Reddit Posts
Anthony Scaramucci Joins Diamond Lake Minerals as Strategic Advisor
Cullen Frost Bankers (CFR)?
Monkeypox: a money making opportunity from the strangest timeline
Let's make monkeypox into a moneybox. $EBS, $SIGA
Let's make monkeypox to moneybox. $EBS, $SIGA
Moody's upgrades AMC's CFR to Caa2 and assigns Caa1 rating to new first-lien notes; outlook positive amid cinema industry's continuing recovery - Moody's
U.S. lawmakers traded an estimated $355 million of stock last year. These were the biggest buyers and sellers
Alpha Metallurgical Resources, Inc. (AMR)
SEC Emergency Orders From 2008 Regarding Short Selling ...They already have the tools to get this going ....SEC do your job or we will shut down pornhub
[$ASO] Moody’s upgrades [$ASO] Academy Sports and Outdoors’ debt ratings due to the chain’s “continued outperformance..."
“72 Hours Later” – Another Due Diligence, by the Socially Incompetent. Let's Go Back in Time and take a Historical Look at NYSE Threshold Securities List. But Wait There is More..."I also make Excellent Stroopwafels!" 🤣AMC ❤️GME Together Strong 💎🙌🏽💎🚀🛰🌖🪐
“72 Hours Later” – Another Due Diligence, by the Socially Incompetent. Let's Go Back in Time and take a Historical Look at NYSE Threshold Securities List. But Wait There is More..."I also make Excellent Stroopwafels!" 🤣AMC ❤️GME Together Strong 💎🙌🏽💎🚀🛰🌖🪐
[PBYA] North American Crane Bureau Expands its Training Footprint with Several Fortune 500 Companies
MEGA CHAD and CLF CEO Laurenco Goncalves to be named "Steelmaker of the Year" this week
MEGA CHAD and CLF CEO Laurenco Goncalves to be named Steelmaker of the Year this week
MEGA CHAD and CLF CEO Laurenco Goncalves to be named Steelmaker of the Year this week
$CLF Rating Action: Moody's upgrades Cleveland-Cliffs; outlook positive
How to Abuse the SSR Rule. A Guidebook to Melvin & Friends F***ery
$VTVT, severely undervalued biopharmaceutical company (diabetes) for the long term, with short-term catalyst this week DD
$VTVT, severely undervalued biopharmaceutical company (diabetes) for the long term, with short-term catalyst this week
$VTVT, severely undervalued biopharmaceutical company (diabetes) for the long term, with short-term catalyst
Mentions
Sure, building reactors takes time and money- that’s true for everyone in advanced nuclear. However, calling Oklo a ‘leech’ ignores that they’re the first private company with DOE reactor site authority at INL, have broken ground, and are actively moving forward with infrastructure, pilot operations, and commercial framework deals like the 12 GW with Switch. The first Aurora reactor is designed as a demonstration under DOE oversight, which is exactly how new nuclear designs de-risk for future commercialization; EBR-II, CEFR, and CFR-600 all followed similar phased approaches. As for sodium heat pipes, Oklo’s design has been vetted with regulatory and engineering review, and they’re leveraging decades of research on sodium fast reactors. Yes, technical risks remain, but that’s the nature of early-stage advanced nuclear… it doesn’t make the company a scam or ‘pump and dump.’ Investors aren’t buying instant profits- they’re backing milestones, federal authority, and a credible path to scale, which is very different from hype.
From a very good comment: >Oklo's extraordinary 20+ billion valuation is presumable based upon the premise that it will meet its goals of deploying its 1st Aurora powerhouse by late 2027 & rapidly scale its fleet to meet its 14,000MW of non-binding master power agreements and letters of intent. That's 186 Aurora powerhouses (75MWe) by 2044 or approximately 9 reactors per year. To evaluate how realistic these goals are it is instructive to analyze the most recent newcomer to sodium fast reactor technology (NaFR), China. China is leading the world in the deployment of conventional light water reactors as well as exotic designs like HTGRs, MSRs & SMRs with a total of 29 currently under construction. The Chinese, working closely with the Russians, who have had a continuous NaFR program for the last 70 years, began development of a single 20 MWe CEFR sodium fast reactor in 1992. They began construction in the year 2000, connected to the grid in 2011 at 40% power & achieved their first full power run in December of 2014 which lasted 72 hours. That's 14 years from start of construction to spotty performance of a single NaFR with the experienced Russians providing the Chinese program with hundreds of pieces of critical equipment, installation & commissioning supervision as well as staff training. With lessons learned China has now deployed a Russian inspired, 600MW commercial unit, the CFR-600 after 6 years of construction. Unlike the Chinese, Oklo Inc intends to skip the prototype learning phase, going straight to commercial power production, obviously without help from the Russians. Rosatom operates two commercial NaFRs with a combined output of 1400MW, 1/10th the capacity of Oklo's ambitious power agreement targets. To support its fast reactor program Russia has over 4000 scientists, engineers & specialists with decades of practical hands on experience in its OKBM Afrikantov design bureau. In contrast, Oklo currently employs 120 people, not all of them engineers. To build, service and support a 14,000MW fleet of Aurora powerhouses they will need an army of sodium (Na) systems engineers, Na chemistry & purification specialists, Na thermal-hydraulics & safety analysts, Na component & materials engineers, Na fuel cycle & pyroprocessing specialists & experienced sodium reactor operators & maintenance crews, roles that take decades to cultivate & cannot simply be invented out of thin air. Sadly there is not a significant pool of experienced NaFR experts outside of China & Russia. The last NaFR operated in the USA, EBR-II, a non-commercial 20MWe NaFR ran from 1964-1994 at Idaho National Laboratories. That's a 31 year gap. In short Oklo's deployment scale and timeline just isnt credible. What is desparately needed in the USA is a common sense focus on learning how to competently deploy large, well understood light water reactors not AI inspired fever dreams about leapfrogging science experiments into scalable commercial products on impossibly short timeframes.
FROM A X POST: Oklo's extraordinary 20+ billion valuation is presumable based upon the premise that it will meet its goals of deploying its 1st Aurora powerhouse by late 2027 & rapidly scale its fleet to meet its 14,000MW of non-binding master power agreements and letters of intent. That's 186 Aurora powerhouses (75MWe) by 2044 or approximately 9 reactors per year. To evaluate how realistic these goals are it is instructive to analyze the most recent newcomer to sodium fast reactor technology (NaFR), China. China is leading the world in the deployment of conventional light water reactors as well as exotic designs like HTGRs, MSRs & SMRs with a total of 29 currently under construction. The Chinese, working closely with the Russians, who have had a continuous NaFR program for the last 70 years, began development of a single 20 MWe CEFR sodium fast reactor in 1992. They began construction in the year 2000, connected to the grid in 2011 at 40% power & achieved their first full power run in December of 2014 which lasted 72 hours. That's 14 years from start of construction to spotty performance of a single NaFR with the experienced Russians providing the Chinese program with hundreds of pieces of critical equipment, installation & commissioning supervision as well as staff training. With lessons learned China has now deployed a Russian inspired, 600MW commercial unit, the CFR-600 after 6 years of construction. Unlike the Chinese, Oklo Inc intends to skip the prototype learning phase, going straight to commercial power production, obviously without help from the Russians. Rosatom operates two commercial NaFRs with a combined output of 1400MW, 1/10th the capacity of Oklo's ambitious power agreement targets. To support its fast reactor program Russia has over 4000 scientists, engineers & specialists with decades of practical hands on experience in its OKBM Afrikantov design bureau. In contrast, Oklo currently employs 120 people, not all of them engineers. To build, service and support a 14,000MW fleet of Aurora powerhouses they will need an army of sodium (Na) systems engineers, Na chemistry & purification specialists, Na thermal-hydraulics & safety analysts, Na component & materials engineers, Na fuel cycle & pyroprocessing specialists & experienced sodium reactor operators & maintenance crews, roles that take decades to cultivate & cannot simply be invented out of thin air. Sadly there is not a significant pool of experienced NaFR experts outside of China & Russia. The last NaFR operated in the USA, EBR-II, a non-commercial 20MWe NaFR ran from 1964-1994 at Idaho National Laboratories. That's a 31 year gap. In short Oklo's deployment scale and timeline just isnt credible. What is desparately needed in the USA is a common sense focus on learning how to competently deploy large, well understood light water reactors not AI inspired fever dreams about leapfrogging science experiments into scalable commercial products on impossibly short timeframes.
What I checked and what it shows Official Lockheed material on “Compact Fusion” (background / IP). Lockheed’s Skunk Works has long-published material and a product page describing the Compact Fusion concept and patents tied to it. That IP and concept still exist in public records. Lockheed Martin +1 Patent activity (most important signal to watch). Older CFR patents (2014–2018) describing magnetic-coil/cusp approaches are publicly available (e.g., US9934876B2 / US9947420B2 etc.). Google Patents +1 I also found a recent patent publication entry that looks relevant to modular magnetic confinement and lists a 2025 publication — a document identifier US20250218604A1 / EP4258285A1 showing up in patent indexes (owner listed as Lockheed Martin in the index result). That’s the most direct recent IP signal I could find that is fusion/plasma-relevant. (Patent publications ≠ an announced program, but they’re an important indicator). Google Patents Defense / space / science press (news & journals). Major defense/space outlets (Aviation Week, Defense News, Breaking Defense) and major science outlets (Science, Nature, Scientific American) do not appear to have run authoritative stories confirming a revived Lockheed CFR or an imminent production/first-plasma announcement tied to the recent teaser. There’s coverage of Lockheed’s historic CFR work and general fusion progress in industry, but no confirmed new program restart announced publicly. Aviation Week +2 Science +2 Jobs / hiring (operational signal). Skunk Works job postings are active (RF engineers, software, etc.) which is normal for Skunk Works workstreams; I did not find public job ads explicitly calling for “fusion reactor build/test team” or similar highly-specific CFR hiring in 2025 postings. Active hiring is not proof of a fusion program. Lockheed Martin Jobs +1
$CJMB Revival Health JV (May 2025): Strategic partnership for integrated supply chain in wellness and longevity products, sourcing APIs from South Korea to support onshore manufacturing and importation, unlocking new revenue in the booming health sector. India Subsidiary and Pune Warehouse (June 2025): New facility to secure API imports and tissue samples from India, bridging global supply to U.S. onshoring efforts, aligning with reshoring trends for pharmaceuticals. Trump EO/ASPR Alignment (Aug 2025): Company blog highlights role in API stockpiling for critical meds under the EO, leveraging CEO Wayne Williams' Strategic National Stockpile experience for likely federal contracts and funding. City/State Government Contracts: Extended Chicago deal (July 2025) now $9.1M through 2026 for emergency stockpiling; multi-year pacts with Texas DSHS and Oregon Health Authority, plus support for measles outbreaks, tapping billions in resilience spending. Food & Beverage Expansion: Entering high-end perishables like gourmet samples and beverage kits with sustainable VIP shippers and Sentry monitoring, capitalizing on 15% annual sector growth for e-comm and B2B trials. Potential UPS Collaboration: Tech integration eyed for UPS Premium Platinum beta in advanced cold chain, matching reusables with UPS's healthcare investments, potentially scaling via global network. Innovation and Tech Edge: Proprietary Sentry platform for real-time monitoring (21 CFR Part 11 compliant) and patented SHIP2Q sanitization for reusables, plus VAWD accreditation, positioning for FDA-aligned pharma handling and sustainability Management own 71% of shares locked until 2026 feb. 14 institutions holding 16%. The float right now is 500-600k for us retail. Market cap 22m. Any of thoose catalysts show $ and it will eclipse the m cap. Research yourself the ceo. He was second to be called after president of United states when 9/11 happened to handle the emegency logistics.
Charlie was not hateful, he was a man of God. Turn off the news, it’s all brainwashing propaganda. But this young generation have been lied too your whole life by your teachers. The bankers have been trying to bring communism to the USA since 1921 when they formed the Council of Foreign Relations. You won’t find truth about the CFR online, it’s all been scrubbed. They want two classes elites and surfs and if hanging out here your not an elite.
I think it's been said for a while this one is a filler. They seem to be concentrating efforts on the next model which is meant to be a new formfactor. (supposedly) BUT, for the pro camera market, this model actually records CFR, which IS a major leap, as it's the first iPhone to offer it.
Here’s the plain-English take: (GPT 5) * **What this is:** A DEA “notice of application” saying the **VA Cooperative Studies Program** (a VA research arm in Albuquerque, NM) applied to become an **importer** of two **Schedule I** cannabis items: **Marihuana Extract (7350)** and **Tetrahydrocannabinols (7370)**. It’s specifically to import **finished dosage units** **for research and clinical trials only**. * **What it is** ***not*****:** It does **not** change cannabis scheduling, legalize commercial sales, or approve any product for patients. DEA even states authorization **will not extend to importing FDA-approved or non-approved finished products for commercial sale**—only research use allowed. * **Why the notice exists:** Under DEA rules (21 CFR 1301.34), importer applications must be publicly noticed so affected manufacturers/applicants can **comment or request a hearing**. The public comment/objection window is **30 days after Federal Register publication** (this one is scheduled to publish **Sept 8, 2025**). * **Dates/details:** The VA program **applied May 9, 2025**. Publication slated for **Sept 8, 2025**. Comments are submitted via [**regulations.gov**](http://regulations.gov); hearings requests go to DEA’s listed addresses. **Bottom line:** This is a procedural step allowing a VA research group to legally **import cannabis-derived Schedule I materials** for **research/clinical trials**—not a policy shift on commercial cannabis.
Trading on the basis of MNPI (material non-public information) is illegal in the US. Read and understand 17 CFR § 240.10b5-1 first - [https://www.ecfr.gov/current/title-17/chapter-II/part-240/subpart-A/subject-group-ECFRbda83517ce4377f/section-240.10b5-1](https://www.ecfr.gov/current/title-17/chapter-II/part-240/subpart-A/subject-group-ECFRbda83517ce4377f/section-240.10b5-1)
Technically - it's not an SEC rule. It's an FRB (Federal Reserve Board) rule. Rule in the CFR (Code of Federal Regulations) here for people that enjoy reading this type of stuff - [https://www.ecfr.gov/current/title-12/chapter-II/subchapter-A/part-220](https://www.ecfr.gov/current/title-12/chapter-II/subchapter-A/part-220)
I can't say I have a lot of trouble believing this... but I think it means that there might be a more "normal" recession *before* the black swan one that will be caused when an H5N1 genotype evolves to spread easily h2h. Keep watching the novel reassortant in Cambodia currently driving the spike of cases there. Most of its genes come from the 2.3.4.4b clade that's also in the US, but it has kept the 50%+ CFR of the older Asian clade.
Well, one thing to keep in mind is that we'll definitely have a human H5N1 pandemic as soon as a genotype evolves with the specific mutations required for easy h2h transmission. Could be next month, could be a couple of years, but it will happen. Nobody knows what the CFR will be for this genotype, but it's staying steady at 50% right now even when places like Cambodia are finding a lot more cases through improved surveillance. 99.79% of the fatalities current H5N1 genotypes have been in people under 65, and in fact, all flu pandemics ever recorded have fatalities heavily tilted towards younger people. Vance is only 40. So we may not have to worry about that.
Distribution and compounding requires you to comply with GMP regulations 21 CFR 210 and 211. As a former director corporate quality assurance, I could tell you that I would be auditing them and their suppliers for compliance as you do no want to risk your reputation on a third party non-compliance.
I don't think you realize how trivial this is. This was more or less a given. Each jurisdiction has their own civil aviation authority. In the US it's the FAA. In Canada it's TCCA. In Australia it's CASA. Each jurisdiction is responsible for developing their own certification standards. But it obviously makes sense to harmonize cert requirements across jurisdictions, right? Because of that, the respective CAAs will coordinate with each other and develop cert requirements that are consistent, with changes specific to each jurisdiction as they see fit. For example, 14 CFR Part 25 in the FAA is 99.9% the same as TCCA AWM Chapter 525. There are some differences though, such as CAR 525.1301-1 which is a Canada-specific cold-soak requirement that doesn't exist in the FAA realm. That is what this announcement is. It is saying is that the certification framework for advanced air mobility aircraft will be harmonized between these jurisdictions *just like every other aeronautical product.* Despite Archer's CEO's statement kissing the ring of Trump, Archer has no role in this announcement. Everyone in the AAM space 'benefits' equally whether it be Archer, Wisk, Joby, etc. This news release is literally just them making a news release for an agreement that *they aren't a party in.*
I used to work in Computer Systems Validation under 21 CFR Part 11 (Electronic Records/Electronic Signatures). That's a big fancy CFR that requires computer systems from slide strainers to pill fillers to be calibrated and validated for accuracy, tested, and documented with respect to system testing. It gets as specific as the equipment used for animal testing and chemistry and manufacturing. It's a really, REALLY big deal. And that's not a space where cuts need to be made. Drug prices are high because stock prices need to be up. But also, drug prices are high because the scientists and manufacturing techs and everyone in the work flow need to still be paid a high wage for ensuring that the literal medicine supply in the US for humans and animals is consistent, sterile, and safe, from batch to batch.
Don't worry, I don't think Trump even knows what 10CFR50 is
You post utter nonsense.. the type B meeting is this month (may) They cannot submit a sBLA for lymphopenia as it’s a new indication.. see fda guidance or CFR 21. They can only do sBLA for bladder. There are no robust studies for treating lymphopenia with NAI. Ibrx will do a study with a comparator arm across chemo, radiation etc Then they will submit a BLA
Commercial truck drivers are already required to be able to speak, read, and write English under 49 CFR § 391.11(b)(2)). It's like they didn't even look at the law before deciding to sign a totally redundant EO that he probably doesn't have the authority to enforce.
There is already a federal regulation under CFR 391.11(b)(2) that requires drivers of commercial motor vehicles to read and speak English sufficiently enough to converse with the general public and respond to official inquiries. This is already the law so the EO seems pretty meaningless?
I agree with most of this but I think a lot people overestimate the current strength of the Chinese economy and view it from 2015 Rose Tinted Glasses. I went to a John Quincy-CFR talk at Citi Bank in summer 2019 and their CIO for East Asia was talking about how they’ve known China has been lying about at least 2-3% of their growth since 2015 looking at raw output in tonnage and correlating it to smoke stack activity, there were several other ways of measuring that also led to the same conclusion. Supposedly their economy is currently growing, while they have been simultaneously experiencing deflationary pressure for the last year. So if I had to pick between Ray Dalio and Peter Zeihan I would say Peter is probably closer to right and most people agree with his assessment but not the apocalyptic degree to his conclusions.
We discuss this in much more detail in r/H5N1_AvianFlu \-- please come and check it out! :) But yes, there is a major preponderance of deaths and severe cases in younger people in all reliably recorded flu pandemics. 1918-1920, 1957-8, 1968, 2009. The 1889-1890 "Asian flu" and "Russian flu" pandemics almost certainly fit into that category too, but the reliability of the records becomes more of an issue. But here is what's so interesting: 80% of all deaths in the 2009 H1N1 pandemic were in people under 65, the great majority in those under 50. Antivirals and antibiotics (for secondary infections) made no difference to these proportions. The genotype that caused the pandemic simply happened to be one with an extremely low CFR, far below 1%. Will we get that lucky again? Anyway, to keep from going more off topic here, I'll leave it at this: think about the economic impact that a flu pandemic with even a 2-3% CFR might have when it's heavily concentrated among young working people.
If a president were to forcibly remove a sitting member of an independent agency it will almost certainly be taken up by the Supreme Court. The Supreme Court would then have to clarify previous decisions and either extend or limit the presidents removal power. I would guess that the Supreme Court would be drowning in briefs supporting the limitation of the president to remove the CFR. If they allowed the removal, I think capital would be flood out of the US so fast you would see major issues.
Agreed. Still. They're "sharing the URLs to buy directly". That's news. Bubble boy it is. For your convenience: (Dunno about Ferrari tho.) Here are 10 of the top publicly traded luxury brands, along with their stock tickers and primary listings as of April 2025: 1. LVMH Moët Hennessy Louis Vuitton • Ticker: MC.PA (Euronext Paris) • Overview: The world’s largest luxury conglomerate, owning brands like Louis Vuitton, Dior, Tiffany & Co., and Hennessy. 2. Hermès International • Ticker: RMS.PA (Euronext Paris) • Overview: Renowned for its Birkin bags and leather goods, Hermès boasts some of the highest profit margins in the industry.   3. Kering • Ticker: KER.PA (Euronext Paris) • Overview: Parent company of Gucci, Saint Laurent, and Bottega Veneta, Kering is a major player in the fashion luxury sector.  4. Ferrari N.V. • Ticker: RACE (NYSE) • Overview: Italian luxury sports car manufacturer known for its exclusivity and high-performance vehicles.  5. Moncler S.p.A. • Ticker: MONC.MI (Borsa Italiana) • Overview: Famous for its premium down jackets and recent acquisition of Stone Island, expanding its luxury portfolio.  6. Burberry Group plc • Ticker: BRBY.L (London Stock Exchange) • Overview: Iconic British brand known for its trench coats and distinctive check patterns.  7. Estée Lauder Companies Inc. • Ticker: EL (NYSE) • Overview: A leading global beauty company with a portfolio that includes Estée Lauder, MAC, and La Mer.  8. Tapestry, Inc. • Ticker: TPR (NYSE) • Overview: Owns Coach, Kate Spade, and Stuart Weitzman, offering a range of luxury accessories and footwear.  9. Compagnie Financière Richemont SA • Ticker: CFR.S (SIX Swiss Exchange) • Overview: Swiss-based holding company owning Cartier, Montblanc, and other high-end brands.  10. Prada S.p.A. • Ticker: 1913.HK (Hong Kong Stock Exchange) • Overview: Italian luxury fashion house known for its innovative designs and recent acquisition of Versace.
You make a lot of good points, and this isn't even taking the future impact of H5N1 into account. There will be a human pandemic within the next year to year and a half at most. I've made some very, very long posts about exactly why this is the case over on r/H5N1_AvianFlu , and I will post more info if people want to see it, but suffice it to say, everything points in that direction. We saw what a black swan event COVID was, but this will have a much more profound and lasting economic impact. The basic reason is that the demographics of the fatalities and serious cases are and will be exactly the opposite of COVID, with the great majority in younger people and relatively very few over age 65. That's exactly how every flu pandemic ever recorded has behaved, and that's how fatalities in the rarer human H5N1 cases to date are actually playing out too. So young workers will be dying. I'm not trying to say that we'll have the same number of deaths as in the 1918-1920 pandemic, but it's unlikely that we'll be as lucky as the world was during 2009, with the exceptionally low CFR of the genotype that happened to be the most communicable one. This is simply not a factor that almost anyone is pricing in.
There is definitely another pandemic coming within the next 18 months, though. We discuss the impending human H5N1 pandemic on r/H5N1_AvianFlu , so check us out if you want to know more. The level of severity that this will have on markets and the amount of time it might last depends on if the CFR is closer to the 1918-1920 pandemic or to H1N1 in 2009. But I do think there will be an effect.
7.) Whether or not the human H5N1 pandemic begins by the end of the year. It's impossible to say if the necessary mutations will happen by then, but if the H2H genotype does emerge and start spreading, then all economic bets are off. There are a lot of reasons, but one is that the demographic for fatalities and serious cases in all flu pandemics is exactly the opposite of COVID. Younger adult workers, teens, and children will be at the greatest risk by far. If the CFR is close to that of COVID, then the ripple effects on the world economy could be unlike anything seen in the past 100 years. You'd really need to go back to the 1918-1920 pandemic to see anything similar.
You're missing the economic impact of the coming human H5N1 pandemic, but to be honest, so is virtually everyone else. This one is very difficult to call. The option of the virus *never* evolving to spread easily between humans is off the table by this point; I would bet every cent on that. Based on the steady, stepwise evolution of the virus since 2020 and the current admin's attitude towards the risk, I would guess that the crucial mutations needed will happen 12-18 months from now. The best case scenario (that is realistic at all) is essentially a repeat of the 2009 H1N1 pandemic. The human impact should not be underestimated-- about 300,000 people died worldwide-- but the CFR was so low that there wasn't much impact in either the markets or the larger economy. However, the demographics of the deaths were the same as in all flu pandemics ever reliably recorded-- largely tilted towards younger people. A full 80% of all deaths were under age 65, and most of those were under age 50. So in a new avian flu pandemic, the CFR of COVID would cause enormous economic problems. It doesn't need to be the 50-60% fatality rate that H5N1 has had so far in humans, which is very unlikely to hold up in an H2H genotype. Anyway, this one factor has enormous economic implications and is almost never taken into account when looking at the next year to year and a half.
This isn’t accurate at all. Duties are based on the price the US consumer purchases the item for, plus insurance and freight. https://www.help.cbp.gov/s/article/Article-1162?language=en_US#:~:text=All%20prices%20in%20foreign%20currency,CFR%20141.89%20for%20a%20guidance.
Depends on what value they declare on the commercial invoice. Duties are based on CIF (Cost, Insurance and Freight) Most manufacturers in China declare their selling costs so they pay their taxes upfront when they export. US Customs demands that the seller show the final sale price listed on the commercial invoice, not the cost to manufacture: https://www.help.cbp.gov/s/article/Article-1162?language=en_US#:~:text=All%20prices%20in%20foreign%20currency,CFR%20141.89%20for%20a%20guidance.
**MORE LIES** #1: The intent to treat population (whole) is the main discussion of the paper. They do also have a pre-specified genetic subgroup that covers over 70% of the patient population and has an even better response to the drug. #2: Clinical trials can be conducted outside the U.S. and still be used in support of FDA approval, as long as: • The study complies with Good Clinical Practice (GCP), which includes ethical and scientific quality standards. • The data is relevant to the U.S. population and medical practice. • The FDA can inspect the data and sites if needed. 21 CFR 312.120 is the regulation that governs acceptance of foreign clinical study data not conducted under an Investigational New Drug (IND) application.
You are forgetting one crucial detail here, the world was not nearly as economically interdependent as it is today. Today worldwide shipping is so efficient you can have product be 10x cheaper to produce in 20 factories all in different nations than in one plant. A tv is assembled for instance with parts made in dozens of hundreds of factories in dozens of states around the world. What happens to this system of vast interconnectedness when the largest market takes their ball and goes home? The answer is we don't know, but it will be much worse than before. Im not a professional, I just listen to them. Professor Jennifer Hillman to be exact, an international economic law professor at Georgetown and senior fellow for trade and international political economy at the CFR is who I'm paraphrasing here. I've taken a couple courses the past year around international trade law/regs and every single professor says the same thing, it's going to be worse. Call me a doomer all you want Reddit, it's the truth.
Devils advocate. 1. new tariffs daily (now unlimited power per CFR) 2. Still very high p/e for growth stocks 3. The world is trying to boycott the USA because they view the US as hazardous now. Still waiting on the gdp contraction data to dry.
That’s only a European rule. Americans have a lot of leeway with what can be called champagne. 27 CFR 4.21(b)(2) Champa*gne* is a type of sparkling light [wine](https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=d57d60ac8567f8a242e568bea8e4eb5c&term_occur=999&term_src=Title:27:Chapter:I:Subchapter:A:Part:4:Subpart:C:4.21) which derives its effervescence solely from the secondary fermentation of the [wine](https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=d57d60ac8567f8a242e568bea8e4eb5c&term_occur=999&term_src=Title:27:Chapter:I:Subchapter:A:Part:4:Subpart:C:4.21) within glass [containers](https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=0feb594b0622b7dc28facdfec72b9312&term_occur=999&term_src=Title:27:Chapter:I:Subchapter:A:Part:4:Subpart:C:4.21) of not greater than one [gallon](https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=11eba0dfaa00324cb7561242352cad36&term_occur=999&term_src=Title:27:Chapter:I:Subchapter:A:Part:4:Subpart:C:4.21) capacity, and which possesses the taste, aroma, and other characteristics attributed to champagne as made in the champagne district of France. \^Federal regulation on labelling of wine/champagne. In Europe it’s about the region, in the US, it’s about verisimilitude
so i am now a TSLA put bag holder because of 🥭 violating 5 CFR § 2635.702 - Use of public office for private gain is not allowed. guess i'll just hold them till they expire 4/11, theta gonna eat my ass
Are you sure that folks not investigating and offering their takes in an informed, non-biased manner wouldn’t be better than “questing the vitality under the current administration” constantly which effectively contributes nothing but baseless fear mongering? You know, when the fundamentals are ok—good, according to Powell—maybe we shouldn’t encourage partisans to foment hysteria. Btw, Trump’s actions re Mexico and Canada are simply part of a pre-planned USMCA compliance review that has been scheduled to occur in 2026 since 2020. Our enemy in this market quite literally is fear itself. And partisan nonsense designed to harm Americans and the market. Don’t fall for it. CFR has a great article on Trump and the USMCA!
At a minimum, products that are made from imported materials and subsequently sold in the US will owe tariffs and duties on the imported materials. In most cases, the tariffs and duties apply to the final product. Seeing as how we are trying to encourage domestic chip production, they likely get the benefit of only paying duties on the value of the imported materials, but they are not exempt from tariffs and duties altogether. If they were not importing materials to begin with, there wouldn't be much advantage to an FTZ designation. >If admitted to an FTZ in “privileged foreign” (PF) status (19 CFR 146.41), any U.S. duty(ies) paid is at the rate(s) applicable to the merchandise in its condition at the time of admission – regardless of whether the merchandise was transformed under FTZ procedures into a different product. >If a foreign-status component is used to make a product that is shipped to the U.S. market, U.S. duty(ies) on the value of the foreign-status component generally is payable at the rate that applies to the product. The exception is when the component’s FTZ admission was in PF status – including in circumstances below that are examples of requirements for admission in PF status.
Great birdflu hitting the US. And we got just the man for the job in charge again. And here’s the kicker bois, it can be transmitted through air inhalation. Ooh and to make things worse: NB: This table is updated following updates from the source. Globally, from 1 January 2003 to 12 December 2024, 954 cases of human infection with avian influenza A(H5N1) virus were reported from 24 countries. **Of these 954 cases, 464 were fatal (CFR of 49%).**
The market and economy have been disjointed for several years now. This inflation was not real inflation look at corporate profit. It was designed to take money out of the pockets of the masses and make us poorer. Trumps victory was a hit in the face of the true oligarchs. The (WEF) World Economic Forum, UN, (CFR) Council of Foreign Relations and other oligarchs groups are not on Trumps Christmas card list. He has had run ins with members of these elitists in the past. That is one of the reasons they have taken him to court at every turn, since his first election victory. The WEF lead by Klaus Schwab, Bill Gates, George Soros and elite bankers has plans to chip everyone and have your assets in your chip, you do something wrong and they can take some or all your assets. They’ve been taking lessons from the CCP. We were heading for a two class society, elites and serfs. You can’t watch the brainwashing propaganda more commonly called the main stream media news as they orchestrate just what they want us to believe. I suspect Soros pays a lot of folks on this site to keep the agenda going, it’s sad. I would like to see more leaders that come from business, and have had to make a payroll before, file corporate taxes, pay employees insurance premiums. Typical politicians don’t have a clue how the economy actually works, they’ve never been members of our reality.
It's a very fair question. And tbh - I am not sure that I know the answer. I do not know what defines an investment adviser to be a "fiduciary" - if that concept even exists. Afaik - a fiduciary is a trustee. And the Advisers '40 Act doesn't use the term fiduciary other than to describe bank trustees. Similarly, the SEC rules and regulations related to the Advisers '40 Act - 17 CFR Part 275 also doesn't define "what is a fiduciary". I'm probably splitting hairs - but it's my understanding that it's more that all advisers have obligations to meet the standards of duty and loyalty like a fiduciary versus actually being a fiduciary. The reason why I disclike the usage is because a lot of laypersons believe that it's a distinction that would make an adviser more qualified or somehow more competent. And many people on Reddit lead with the idea that as long as an adviser says that they are a fiduciary - it's all that matters.
Mpox already has a vaccine for it. It’s also not respiratory. This thesis relies on a Covid-19 style event. A novel respiratory virus with high spreadability and not insignificant CFR.
See my other comments. CFR is usually high at starts of pandemics when diseases are clunky. Very likely undercount of cases versus deaths. This is the Congo - what do you think its data collection capabilities are like? The WHO has been advocating for a long time for better monitoring of diseases in Africa and it’s fell on deaf ears.
Terrible healthcare system. Virtually non-existent in rural Congo. Likely the CFR would be lower in the Western world. However, it should be noted that it is teenagers who are largely dying, so this is potentially a much different disease than COVID-19.
It’s the Congo, the data quality is terrible. Counting the dead is easier than counting the infected. Early estimates in Wuhan were 20% CFR and look where that went.
In order to fly one of these in commercial operations you’re going to need an ATP (that’s the certificate beyond a commercial pilots license, and is required by 14CFR135). Additionally, according to the final rule issued a few weeks ago each powered lift aircraft will require a full and separate type rating making it more expensive to train pilots compared to typical fixed wing or rotorcraft.
This breaks it down: [https://en.wikipedia.org/wiki/United\_States\_support\_for\_Israel\_in\_the\_Israel%E2%80%93Hamas\_war#Weapons\_transfers](https://en.wikipedia.org/wiki/United_States_support_for_Israel_in_the_Israel%E2%80%93Hamas_war#Weapons_transfers) basically the US has been sending israel a shitton of weapons for a while, the economic aid was pre-2020. It's now pretty low but I couldn't find the economic aid other than the CFR. I'm open to other sources.
Not really a neutral source, the CFR. AP reports that, of the 18B, about 4B was spent on US stuff and 4B was given to Israel to replenish the Iron Dome. The rest is not explained by the US government.
I’m buying Kering in large quantities. The stock and sector are completely undervalued. I hope the stock will rise by over 20% soon. Louis Vuitton, MC, is much more resilient. It’s dropping less sharply than Kering, which makes Kering a riskier stock. [https://companiesmarketcap.com/luxury-goods/largest-luxury-goods-companies-by-market-cap/](https://companiesmarketcap.com/luxury-goods/largest-luxury-goods-companies-by-market-cap/) CFR could, also, a nice option, with Swatch Group.
It’s the standard across most industries that used to require wet-ink signatures. It is CFR compliant, auditable and holds up to legal scrutiny. They charge for seats and licensing across all of these markets. I’m still dubious on buying before EA. I’ve seen these drop with good earnings. May be a “ya but what else ya got?” Market response.
# 1. Notice of Hearing (21 CFR § 1316.50) * After a request for a hearing is filed, the ALJ issues a notice specifying the time and place for the hearing. The parties involved (typically the respondent and DEA) are notified in writing. # 2. Submission of Pre-Hearing Statements and Evidence * **Pre-hearing Exchanges:** Each party must submit a pre-hearing statement, including lists of witnesses, summaries of testimony, and exhibits. The ALJ sets deadlines for these submissions. * **Evidence Submission Deadline:** Evidence (documents, testimony, etc.) must be submitted before the hearing. The ALJ typically sets a specific deadline for this (it could be 30 days or a different timeframe). # 3. Pre-Hearing Motions (21 CFR § 1316.57) * Either party may file motions, such as a motion to dismiss or for summary judgment. The ALJ rules on these motions before the hearing to decide whether the case should proceed or be resolved without a hearing. * A pre-hearing conference may be held to discuss issues, simplify the matters at hand, or address procedural questions. # 4. ALJ’s Role in Evidence Review (21 CFR § 1316.59) * The ALJ has the authority to receive evidence and rule on its admissibility. Evidence must comply with federal rules, and the ALJ can exclude irrelevant or redundant material. * The ALJ can also issue subpoenas for witnesses and documents if necessary. # 5. Conduct of the Hearing (21 CFR § 1316.54) * During the hearing, the ALJ oversees the presentation of evidence by both parties, ensuring that procedural fairness is maintained. * Witnesses may be examined and cross-examined, and both sides have the opportunity to argue their case. # 6. Decision After Hearing (21 CFR § 1316.65) * After reviewing the evidence and hearing arguments, the ALJ issues a written **recommended decision** based on findings of fact and conclusions of law. * The ALJ submits this recommendation to the DEA Administrator, who makes the final decision. # 7. Dismissal or Cancellation of Hearing * A case can be dismissed or a hearing canceled if evidence is deemed insufficient by the ALJ, or if the parties reach a settlement before the hearing. * Motions to dismiss can be filed by either party, and the ALJ can issue a ruling based on these motions if evidence shows no genuine issue of fact or law. # 8. Appeals (21 CFR § 1316.66) * If either party is dissatisfied with the ALJ’s recommended decision, they can file exceptions with the DEA Administrator. The Administrator then issues a final decision.
52% mortality rate my ass. The cases they have detected have been a verry small amount of people that are severely ill and doesn’t consider anyone that’s had it and went undetected and recovered. The real CFR is a tiny fraction of that.
Seek counsel and read: Gift Tax [26 USC 2512](https://www.law.cornell.edu/uscode/text/26/2512) [26 CFR 25.2512-2](https://www.law.cornell.edu/cfr/text/26/25.2512-2) Estate Tax [26 USC 2031](https://www.law.cornell.edu/uscode/text/26/2031) [26 CFR 20.2031-2](https://www.law.cornell.edu/cfr/text/26/20.2031-2)
That's clade 2. "The CFR for clade 2 is less than 1%, while 1b’s CFR is roughly 6%." [https://www.cidrap.umn.edu/mpox/mpox-cases-spiking-10-african-nations](https://www.cidrap.umn.edu/mpox/mpox-cases-spiking-10-african-nations)
The clade 1b more lethal than Covid-19, at least for now, in the DRC healthcare system. "The CFR for clade 2 is less than 1%, while 1b’s CFR is roughly 6%." [https://www.cidrap.umn.edu/mpox/mpox-cases-spiking-10-african-nations](https://www.cidrap.umn.edu/mpox/mpox-cases-spiking-10-african-nations) [https://www.cidrap.umn.edu/covid-19/episode-164-only-beginning](https://www.cidrap.umn.edu/covid-19/episode-164-only-beginning) [https://www.theguardian.com/world/2024/apr/20/next-pandemic-likely-to-be-caused-by-flu-virus-scientists-warn](https://www.theguardian.com/world/2024/apr/20/next-pandemic-likely-to-be-caused-by-flu-virus-scientists-warn)
>Schedule 3 pharmaceuticals need to be manufactured to CFR 211 cGMP standards per the FDA. This is a federal requirement. But this isn't worse than under Schedule 1, right? My licensed California weed farm was, technically, "a small scale pharmaceutical manufacturing facility" and we were subject to more stringent water quality standards & inspections than say a car repair shop. Agree about the price compression, California has flatlined as far as demand in the 3 - 3.5 million/lbs per year sold to consumers in dispensaries. They let large (10+ acre) grows start operating in 2021 and the market has been flooded since then, in 2021 10M lbs were submitted thru the dispensary system. Enough people went out of business (it me) volume got down to 4-5M lbs available for sale last year, but likely up to 5-6M this year. Nothing works until we can have interstate commerce, but don't listen to this idiot lol...
Schedule 3 pharmaceuticals need to be manufactured to CFR 211 cGMP standards per the FDA. This is a federal requirement. 280e isn’t going to save shit, it’s just going to create more “margin”, which means more room for the price compression that we inevitably see in every state. Or pharma will beat the shit out of every existing canna company (who are all struggling and run by idiots). Take your pick. It won’t turn out well.
Okay I got some info about that filing. >§ 240.14a–6 Filing requirements. (a) Preliminary proxy statement. Five preliminary copies of the proxy statement and form of proxy shall be filed with the Commission *****at least 10 calendar days prior to the date definitive copies of such material are first sent or given to security holders, or such shorter period prior to that date as the Commission may authorize***** upon a showing of good cause thereunder. So we should get the filled in version complete with call/vote date sometime in the next 10 days. [Sauce](https://www.govinfo.gov/content/pkg/CFR-1997-title17-vol3/pdf/CFR-1997-title17-vol3-sec240-14a-6.pdf)
50% CFR is a big reason for the low R
This is from the S3 NPRM: >...The decision whether an in-person hearing will be needed to address such matters of fact and law in the rulemaking will be made by **the Administrator of DEA**... >**If the Administrator determines to grant an in-person hearing** to address such matters of fact and law in this rulemaking, **the Administrator will then designate an Administrative Law Judge (“ALJ”) to preside over the hearing**. The ALJ’s functions shall commence upon designation, as provided in 21 CFR 1316.52. The ALJ will have all powers necessary to conduct a fair hearing, to take all necessary action **to avoid delay, and to maintain order**... >The ALJ’s authorities include the power to **hold conferences to simplify or determine the issues in the hearing or to consider other matters that may aid in the expeditious disposition of the hearing...** https://www.federalregister.gov/documents/2024/05/21/2024-11137/schedules-of-controlled-substances-rescheduling-of-marijuana
Or this one: Comments must be submitted electronically or postmarked on or before July 22, 2024. Interested persons may file a request for a hearing or waiver of an opportunity for a hearing or to participate in a hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR 1316.47 or 1316.49, as applicable, which must be received or postmarked on or before June 20, 2024. [https://www.regulations.gov/document/DEA-2024-0059-0001](https://www.regulations.gov/document/DEA-2024-0059-0001)
I was wondering why the DEA never formally stated their position: "The CSA vests the Attorney General with the authority to schedule, reschedule, or decontrol drugs. 21 U.S.C. 811(a). The Attorney General has delegated that authority to the DEA Administrator, see28 CFR 0.100, but also retains the authority to schedule drugs under the CSA in the first instance, see28 U.S.C. 509, 510. The HHS Assistant Secretary for Health has provided a recommendation for transferring marijuana to schedule III. In light of that recommendation, the Attorney General is exercising the Attorney General's authority under 21 U.S.C. 811(a) to initiate a rulemaking that proposes the placement of marijuana in schedule III.
>Types of Marijuana to Be Rescheduled >This rescheduling of marijuana would apply to marijuana as listed in 21 CFR 1308.11(d)(23). The rescheduling also would apply to marijuana extracts as defined in 21 CFR 1308.11(d)(58) because they meet the statutory definition of marijuana and, prior to 2017, were included in 21 CFR 1308.11(d)(23). See Establishment of a New Drug Code for Marihuana Extract, 81 FR 90194 (Dec. 14, 2016). In addition, this proposal would apply to Δ9-THC derived from the marijuana plant (other than the mature stalks and seeds) that falls outside the definition of hemp, because it meets the statutory definition of marijuana. This proposal would not apply to synthetically derived THC, which is outside the CSA’s definition of marijuana. Those tetrahydrocannabinols that can be derived only through a process of artificial synthesis (e.g., delta-10-tetrahydrocannabinol) are excluded. HHS provided a recommendation only relating to “marijuana” as defined in the CSA. That definition is limited to the plant (other than the mature stalks and seeds) and derivatives of the plant. Therefore, synthetic THC will remain in schedule I. This rulemaking would not affect the status of hemp (as defined in 7 U.S.C. 1639o), because hemp is excluded from the definition of marijuana. This rulemaking is not proposing to reschedule any drug product containing marijuana or THC that previously has been rescheduled out of schedule I (e.g., Marinol and Syndros). Nor does it impact the status of any previously scheduled synthetic cannabinoids. Really happy to see synthetics like delta8 and delta10 are excluded.
We do NOT need Anne Milgram to sign the rescheduling order. In 1998 it was the DEPUTY ADMINISTRATOR of the DEA who signed the rescheduling of Marinol from Schedule II to Schedule III. "Under the authority vested in the Attorney General by section 201(a) of the CSA (21 U.S.C. 811(a)), and delegated to the Administrator of the DEA by the Department of Justice regulations (28 CFR 0.100) and redelegated to the Deputy Administrator pursuant to 28 CFR 0.104" The Deputy Administrator of the DEA is George S. Papadopoulos. [https://twitter.com/WeedStreet420/status/1787587894384714101](https://twitter.com/WeedStreet420/status/1787587894384714101)
You are right that recreational marijuana will continue to be illegal and operate basically the same. > Medical cannabis is currently already only sold by medically licensed suppliers. Yeah, but those licenses won't be valid anymore. The FDA is going to start treating them the same way as any other schedule 3 drug manufacturer or seller. Its easier for an existing CFR 21 company to manufacture marijuana products than it is for current MSOs to become CFR 21 compliant. Its also easier for Walgreens to stock marijuana than for an MSO to become a general purpose pharmacy.
You don't go to specialty stores for any other drug. You go to a general purpose pharmacist or big established chain. The main reason marijuana dispensaries worked as a business is that laws effectively prohibited any broader purpose business from selling the stuff. Even worse for current operators, the FDA might start subjecting them to the same regulations that apply to every other schedule 3 drugs. So your dispensary has to hire a pharmacist and deal with all the laws that go with selling pharmaceuticals. Your grow operation has to become CFR21 compliant. Those are *really* complex and expensive things to do, with existing players that have a lot of experience and connections to do it.
Major sell again EOD CFR https://preview.redd.it/kw3e500saoxc1.png?width=1008&format=pjpg&auto=webp&s=6fcc9c9bee8daaecffabf4663febaaa6dd0ba9aa
Here's an update specifically to CFR for selling the last two days massive outflow https://preview.redd.it/ek39zsf4fhxc1.png?width=1008&format=pjpg&auto=webp&s=226e7a7fe7d01641044fb771d1c008bcc53c9bd5
Smart. I prefer CFR but a lot of things is see occuring in NYC and CT point to MTB being worse off
u/Fit_Paramedic_4977 has some good DD [here](https://www.reddit.com/r/wallstreetbets/s/w6atliN08C) CFR and MTB
Please see my DD post about CFR and MTB. two large banks with cheap puts, HIGH CRE loans and ready to fall
From the denial letter opening paragraph: “The purpose of this letter is to inform Oklo Inc. (Oklo) of the U.S. Nuclear Regulatory Commission (NRC) staff’s decision to deny the custom combined license application for the Aurora micro-reactor pursuant to the requirements of Title 10 of the Code of Federal Regulations (10 CFR) Part 2, “Agency Rules of Practice and Procedure,” Section 2.108, “Denial of application for failure to supply information.” Because Oklo has provided insufficient information, as discussed below, for the NRC staff to establish a schedule to review key safety and design aspects of Aurora, the agency is ending its custom combined license application review and denying the application without prejudice. Oklo is free to resubmit its application supplemented by additional information in the areas described below.”
When it comes to commodities, the first derivative will be a futures contract. They are already being traded in Europe: [https://www.ice.com/products/82800207/Ammonia-Outright-Argus-Ammonia-NWE-CFR-Future](https://www.ice.com/products/82800207/Ammonia-Outright-Argus-Ammonia-NWE-CFR-Future) As far as I can tell, the CME is not yet trading futures on specifically ammonia (only on more general agro-fertilizer), but it's probably a matter of when, not if. Once there are US futures contracts, that's when options on those futures might be viable.
More traditional vaccines could still be useful simply due to existing production capacities. The H5N1 vaccine from Baxter and Audenz from CSL don't rely on eggs. But keep in mind that in case of a high CFR most people would like to have the most effective vaccine possible. And [details matter](https://www.biorxiv.org/content/10.1101/2023.04.30.538854v1.full.pdf). And I refuse to acknowledge Novavax as an equal opportunity. The headlines range from the possibility of bankcrupty to customers paying them so they don't have to actually receive their product.
This is not what I'm talking about. A Quality System is not the same as a Quality organization, and Boeing’s QA organization must be removed out from under their Manufacturing org chart. The FAA does perform quality system audits to determine compliance with the applicable requirements of 14 CFR part 21. The FAA then issues a Production Certificate, FAA Form 8120-4, and a Production Limitation Record, FAA Form 8120-3. What happens after this Certificate is issued? This audit as well as AS9100 certification won't address Boeing DERs (Designated Engineering Representative) acting as the FAA’s representative, signing off on behalf of the U.S. government that they are in compliance with federal safety regulations, as was in the case with the Max 8 MCAS. An FAA certification doesn't mandate that a QA organization be a separate entity from Manufacturing.
It varies by the size of the bank. [From the federal reserve:](https://www.federalreserve.gov/monetarypolicy/reservereq.htm) > The dollar amount of a depository institution's reserve requirement is determined by applying the reserve requirement ratios specified in the Board's Regulation D (Reserve Requirements of Depository Institutions, 12 CFR Part 204) to an institution's reservable liabilities (see table of reserve requirements). The Federal Reserve Act authorizes the Board to impose reserve requirements on transaction accounts, nonpersonal time deposits, and Eurocurrency liabilities. As of January 1, 2024: Low reserve tranche amount = $644.0 Million Exemption amount = $36.1 Million So if a bank has less than $36.1 Million of loans, then the reserve amount is zero. If the bank has between 36.1 and $644 Million, the reserve amount is 3%, and if the bank has above $644 Million, then the reserve is 10%.
It seems that filing this information as an exhibit to the 8-K is allowed by the SEC in lieu of a prospectus. Learned something new. Thanks again. Here is the rule from the SEC website for anyone interested: "Regarding an offering of asset-backed securities registered on Form SF-1 (17 CFR 239.44) or Form SF-3 (17 CFR 239.45), in lieu of providing the static pool information as required by Item 1105 of Regulation AB (17 CFR 229.1105) in a Form of prospectus or prospectus, an issuer may file the required information in this report or as an exhibit to this report."
PBAX filed form 25NSE, checking box 17 CFR 240.12d2-2(a)(3). Is this the same as when a SPAC dissolves ? They just voted to complete the combination. https://capedge.com/filing/1870404/0001354457-24-000075/PBAX-25NSE
It seems like the SEC is about to publish daily Short Interest reports too, which were only available on a biweekly basis. [https://www.reuters.com/markets/us/us-sec-finalize-rules-increasing-transparency-short-selling-market-2023-10-13/](https://www.reuters.com/markets/us/us-sec-finalize-rules-increasing-transparency-short-selling-market-2023-10-13/) It also says: >The rules will be effective 60 days after being publishing in the federal government's register. I found the final rule 17 CFR 240.13f–2 was published on November 1 in the Federal Register [https://www.federalregister.gov/documents/2023/11/01/2023-23050/short-position-and-short-activity-reporting-by-institutional-investment-managers](https://www.federalregister.gov/documents/2023/11/01/2023-23050/short-position-and-short-activity-reporting-by-institutional-investment-managers) So in theory, the new SEC rule is effective since Jan 1... but where are those reports?
I think i saw a few lawyers cite marinol - In the marinol ruling it does cite 811(d) - bc its THC. Its schedule 2 in the UN convention of psychotropics - but still subject to treaty considerations. Heres the reschedule info on marinol - “”DEA will continue to require import and export permits for international transactions involving Marino®, even though Marino® will be transferred to schedule III of the CSA. (As set forth below, to accomplish this, DEA is hereby amending 21 CFR 1312.30 to require import and export permits for international transactions involving Marinol®.) After determining that Marinol® could be transferred to schedule III while maintaining the controls required by the Psychotropic Convention, and after gathering the necessary data, on August 7, 1997, DEA requested from the Acting Assistant Secretary for Health, Department of Health and Human Services (DHHS), a scientific and medical evaluation, and recommendation, as to whether Marinol® should be rescheduled, in accordance with 21 U.S.C. 811(b). https://www.govinfo.gov/content/pkg/FR-1999-07-02/pdf/99-16833.pdf They did a proposed rule.
"rior to FDA approval of Epidiolex, CBD was a Schedule I substance, based on its derivation frommarijuana. To address the Epidiolex approval, DEA placed “approved cannabidiol drugs” into Schedule V of the CSA in September 2018, under 21 CFR 1308.15(f), 6 and asserted that the placement was necessary to carry out United States obligations under the Single Convention.Notably, though, FDA’s review of the NDA for Epidiolex, as well as the subsequent HHS 8FA , found that, “Based on the totality of the available scientific data, CBD does not have meaningful abuse potential. In support of this finding, the evidence for any abuse potential is also substantially less than that of all substances currently in Schedule V.”
Federal Aviation Regulations (FARs) are different. 14CFR is not driven by corporate interest, and is not suggested or subjective. The FARs are the backbone of why the US has the safest air travel in the world. It's not about IP, patent control, or design selection, it's about keeping people alive in the air. This is why it's astronomically worse when a company like Boeing captures the regulators and overlooks the regulations. When the FARs are not followed people die, and in potentially large numbers on one event. Corporate interest is always driven towards bending the FARs as far as possible, or even pencil whipping and breaking them when you have your own regulators like Boeing. I see your argument, but my day job is repairing aircraft, and more specifically paperwork and regulations. You are taking more about creations of industry standards, bidding wars and product solutions. FARs are written in blood.
I got you - you have a much better handle on this than me. I see what you mean - but ya - DEA likely to not complicate this further. Epidiolex made an appearance: This included the FDA-approved product Epidiolex, which contains plant-derived, highly purified CBD as its active ingredient and was approved by FDA in June 2018, just prior to the enactmentofthe Farm Bill. Prior to FDA approval of Epidiolex. CBD was a Schedule I substance, based on its derivation from marijuana. To address the Epidiolex approval, DEA placed “approved cannabidiol drugs” into Schedule Vof the CSA in September 2018, under 21 CFR 1308.15(f)," and asserted that the placement was necessary to carry out United States obligations under the Single Convention.
The issue is the court may decide civil penalties and administrative justice is not constitutional. How would that not be catastrophic? Courts haven't been expanded since 1990 even though our population is larger by 82 million. CFR is 4x as large as US Code. Suddenly pushing all administrative justice on to the courts so everyone gets a trial for when they break every federal statute would be chaotic... at best.
This is so absurdly overblown get real. As someone who has wasted his life on combing through the CFR, there is no way that the “catastrophic” effects described by this “opinion” piece would materialize. Moreover, the SEC is a complete joke have you read some of their rules? 10b-5 needs to go back into the garbage anyways.
It's 16 CFR § 233.1. No idea if there are any actual penalties for breaking said law. [https://www.law.cornell.edu/cfr/text/16/part-233](https://www.law.cornell.edu/cfr/text/16/part-233)
Afaik - it's not considered insider trading in your scenario. The misappropriation theory as it applied to insider trading would require that the material non-public information be obtained through a breach of fiduciary duty. You can read more details of 17 CFR § 240.10b5-1 in the eCFR here - [https://www.ecfr.gov/current/title-17/chapter-II/part-240/subpart-A/subject-group-ECFRbda83517ce4377f/section-240.10b5-1](https://www.ecfr.gov/current/title-17/chapter-II/part-240/subpart-A/subject-group-ECFRbda83517ce4377f/section-240.10b5-1) This was codified after US v. O'Hagan - [https://supreme.justia.com/cases/federal/us/521/642/](https://supreme.justia.com/cases/federal/us/521/642/)
**UNITED STATES** **SECURITIES AND EXCHANGE COMMISSION** **Washington, D.C. 20549** **FORM** **8-K** CURRENT REPORT **Pursuant to Section 13 or 15(d) of the Securities and Exchange Act of 1934** **Date of Report (Date of earliest event reported):** **October 18, 2023** **PRESSURE BIOSCIENCES, INC.** (Exact name of Registrant as specified in its charter) **Massachusetts** **001-38185** **04-2652826** **(State or other jurisdiction** **of incorporation)** **(Commission** **File Number)** **(IRS Employer** **Identification No.)** **14 Norfolk Avenue** **South Easton,** **MA** **02375** **(Address of principal executive offices, including zip code)** **(508)** **230-1828** **(Registrant’s telephone number, including area code)** Check the appropriate box below if the 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions: ☐Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)). Securities registered pursuant to Section 12(b) of the Act: **Title of each class** **Trading Symbol(s)** **Name of each exchange on which registered**N/A N/A N/A Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ **Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.** On October 18, 2023, the Board of Directors (the “Board”) of Pressure BioSciences, Inc. (the “Company”) approved an amendment (the “Amendment”) to the Pressure BioSciences, Inc. 2021 Equity Incentive Plan (the “Plan”). The Plan originally provided that no one person could be granted awards pursuant to the Plan during any one fiscal year to purchase more than 300,000 shares of the Company’s common stock, par value $0.01 per share (the “Common Stock”). Pursuant to the amendment, the yearly limit for any one person was raised to 500,000 shares of Common Stock. On the same date, the Board granted stock options to a number of employees and consultants along with the stock options detailed below to four members of the Board (Jeffrey Peterson, Kevin Pollack, Vito Mangiardi, and Mickey Urdea) and to each of the Company’s named executive officers (Richard Schumacher, Edmund Ting, and Alexander Lazarev) with each option having an exercise price of $0.25 per share (one cent higher than the $0.24 closing price of the Common Stock on October 17, 2023). Each award of options expires on October 18, 2033. The options for the members of the Board vest in equal amounts over twelve (12) months. The options for Mr. Schumacher and Drs. Ting and Lazarev were each vested 25% on the date of issuance and 25% of the options vest each year for the next three (3) years. The Board members were granted the following options to purchase shares of Common Stock: Mr. Peterson – 162,980; Mr. Pollack – 86,103; Mr. Mangiardi – 79,953; and Mr. Urdea – 73,802. The named executive officers were granted the following options to purchase shares of Common Stock: Mr. Schumacher – 338, 261; and each of Drs. Ting and Lazarev – 92,253. In addition, on the same date, the Board approved the repricing of all outstanding options (including those held by the Board members and the named executive officers) to $0.25. The previous exercise prices of the outstanding stock options held by the Board members and the named executive officers ranged from $0.69 to $1.50. **SIGNATURE** Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. **PRESSURE BIOSCIENCES, INC.** Date: October 23, 2023By:*/s/ Richard T. Schumacher* Richard T. Schumacher President and Chief Executive Officer
Slide 21 and slide 11 [https://s201.q4cdn.com/298572669/files/doc\_presentations/2023/10/ICU-Investor-Presentation-101023-final.pdf](https://s201.q4cdn.com/298572669/files/doc_presentations/2023/10/ICU-Investor-Presentation-101023-final.pdf) They have already shown probable benefit and there are zero safety concerns, shown in their trails. "The correspondence further indicates that an Approvable Letter, which is a standard part of CBER’s approval process, is expected to be issued within a month. The Approvable Letter will outline conditions, including language for safety, probable benefit and labeling for intended use, which will be required for formal marketing approval. " [https://investors.seastarmedical.com/news/news-details/2023/SeaStar-Medical-Provides-Regulatory-Update-Regarding-Selective-Cytopheretic-Device-Use-in-Pediatric-Acute-Kidney-Injury-Under-a-Humanitarian-Device-Exemption/default.aspx](https://investors.seastarmedical.com/news/news-details/2023/SeaStar-Medical-Provides-Regulatory-Update-Regarding-Selective-Cytopheretic-Device-Use-in-Pediatric-Acute-Kidney-Injury-Under-a-Humanitarian-Device-Exemption/default.aspx) To be given the CBER approval means they have met the criteria. And just need to submit for "Formal Marketing Approval" which they will get back between December/January, then the order will be placed at the same time. # "Biologics License Applications (BLA) Process (CBER) The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards. Form 356h specifies the requirements for a BLA. This includes: * Applicant information * Product/Manufacturing information * Pre-clinical studies * Clinical studies * Labeling" [https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber](https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber)
FDA roles under the Controlled Substances Act (CSA): • Assisting the Drug Enforcement Administration (DEA) on protocol registration for Schedule I drug research (Under 21 CFR 1301.18 and 1301.32) • Conducts scientific and medical analysis (‘8-factor analysis’) to recommend appropriate controls under the CSA (working with NIDA) – At DEA request – Responding to citizen petitions – New approved drug products with need for scheduling action • Under the FD&C Act, any product, including a cannabis product (hemp or otherwise), that is marketed with a claim of therapeutic benefit, or with any other disease claim, is considered to be a drug. A new drug must be approved by the FDA for its intended use **before it may be introduced into interstate commerce.** we dont need to agree
[Dalian met coal rising](https://i.imgur.com/AHPwtQ7.png) (that's a domestic Chinese benchmark). > Chinese coking plants implementing a 3rd rd of coke price hikes, w increases of up to RMB 150/t (~$20.56), effective Oct 11. However, steelmakers are largely resisting this proposed hike due to widening losses & some are scheduling maintenance on blast furnaces & re-rolling lines India hiking steel prices: > Indian #steel co's considering price hikes of $25-50/t for various grades by Dec due to **escalating import costs of raw materials** [met coal....], primarily from major producer Australia. India aims to diversify import sources, including Russia & US, and increase domestic #cokingcoal production. Asian seaborne met coal prices rising: > Asian #metcoal has risen due to tight supply and strong demand. PLV HCC is at $361/mt FOB Australia & $285/mt CFR China. An Indian end-user in discussions for a part cargo of Nov-loading Australian PMV, w fixed price indications ~$370-$375/mt. Dutch TTF natural gas up 12% today. (Good news for thermal coal). US natural gas also rising: "NYMEX prompt #naturalgas futures reached their highest since mid-Jan, trading at $3.47/MMBtu, before settling ~$3.38." (I think that's the same thing as Henry Hub?) Overall, good news for coal.
and the former CEO of Foxconn is running in Taiwan on the presidential campaign: Reunite under me, or get destroyed in war ... i think US gov estimates 2027 being when China will be ready to invade. thats also when their hyper-sonic arsenal will be ready, China did few tests only recently. also from i read in some CFR article, Taiwan can be invaded only in spring or in Autumn
Aviation parts Brokerage or 14 CFR part 145 repair station
On the subject of CFR’s balance sheet, do you have a view on the bank’s loan portfolio exposure to commercial real estate (CRE)? The commercial real estate market is looking pretty grim right now, most especially in commercial office space. To take one example, [Morgan Stanley](https://www.bloomberg.com/news/articles/2023-04-08/a-1-5-trillion-wall-of-debt-is-looming-for-us-commercial-properties#xj4y7vzkg) forecasts that over the next 18-24 months, overall CRE prices will decline by over 27%, ranging from -15% for multifamily housing to an eye-watering -40% for commercial office. CRE transaction volume is around half what it was a year ago, and shaping up to be the lowest we’ve seen since 2012 or 2013. I mention this because Cullen has among the banking sector’s highest loan portfolio concentrations of CRE, as a whole, and commercial office, in particular. My understanding is that CRE makes up about 35% of Cullen’s loan portfolio, of which about 30% comprises office. So about 10% of the total loan portfolio is commercial office. How do you expect Cullen’s CRE loan portfolio to perform over the next couple years, and what impact do you see that having on the bank’s balance sheet and stock price?
The HHS and DEA don’t make laws. Holy shit, did you read the article you linked? It just repeated everything I’ve said here… thank you for bringing my argument full circle Current hemp manufacturing is only up to CFR 111 and 117 for supplements and food, which they say is insufficient. The FDA needs them to be up to date with 211. As far as the FDA regulating the space; “The FDA will continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate. We will remain diligent in monitoring the marketplace, identifying products that pose risks and acting within our authorities. The FDA looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the public’s health and safety.”
CFR 211 is hardly just about facility requirements. Do you work for MariMed or something? You seem completely brainwashed
You clearly don’t understand GMP if you think being certified from 111 or 117 means you’re anywhere near prepped for 211 🤣🤣 I do this shit for a living, CFR 111 and 117 are a joke. My off the cuff math may be poor, but not as poor as having invested in any of these MSO’s!
No, lmao, you are incorrect. There are multiple different GMP levels. MariMed is CFR 117 certified for FOOD, maybe 111 for supplements. GMP CFR 211 for pharmaceuticals is an entirely different ballgame. Go do some research and come back to me before you talk about things you don’t understand.
Here’s more proof. They’re only GMP for supplements (CFR 111). Do some damn research before you try to tell me I have no clue what I’m talking about 🤣🤣🤣 [“… is pleased to announce that its manufacturing facility in Boulder, Colorado was recently added to NSF International's dietary supplements Good Manufacturing Practice (GMP) registration. Earning GMP registration from NSF International verifies that a manufacturing facility has the proper methods, equipment, facilities, and controls in place to produce dietary supplement products.”](https://investors.charlottesweb.com/press-releases/press-release-details/2020/Charlottes-Web-Earns-NSF-Internationals-Good-Manufacturing-Practice-Registration/default.aspx)
CresTco is a joke. Why do you think charlottes web is partnering with an actual, pharma GMP, pharmaceutical company to manufacture the drug???? BECAUSE THEY’RE NOT CFR 211 PHARMA GMP COMPLIANT! Holy shit, do even the slightest bit of research before you come at me with this nonsense.
You’re mistaken. Charlottes web is CFR 111 or 117 compliant, not 211 for pharmaceuticals. Whole different ball game.