CSF

yellowbreadletter

I agree with you, it is enzymatic activity that matters. Hence, I explained in my post why there was likely a reduction of measured enzymatic activity in CSF. Intracellular GCase activity was not measured, however with respect to clinical results it is likely that intracellular GCase enzymatic activity was significantly increased. The fact that there was more GCase protein in the CSF indicates that the protein was being spared instead of destroyed in the ER of neurons.

yellowbreadletter

I think you should re-read the study data on Ambroxol a bit more carefully. They found a statistically significant increase of GCase levels in CSF of 35% which is quite a large increase. The decrease I believe you are referring to is the enzymatic activity of GCase in the CSF. Ambroxol is pH dependent. The pH of extracellular CSF is 7.4, due to its higher pH the GCase that is being tested in CSF does not allow the Ambroxol to detach from the GCase protein, therefore the protein can not function as an enzyme while bound to Ambroxol. Ambroxol is a weak base and binds to GCase at higher pH levels and detaches at lower pH levels, once reaching the lysosome where the pH is approximately 5.0 Ambroxol detaches from GCase allowing it to perform its enzymatic function. Study participants also showed an average of a 6.8 point reduction in MDS-UPDRS part III motor scale, which was a greater increase than was seen in the 1B trial for GT-02287. Certainly GT-02287 appears to be a better targeted treatment not requiring the patient to take 19 tablets per day, but if there is a generic that is "almost as good" then big pharma may be reluctant to make an acquisition here. I do look forward to reading the biomarker data on GT-02287 however.

ImaginationRoutine96

You’re framing this like Gain is clueless about whether the drug gets into the brain, but that shows you haven’t actually looked at the data. They already measured CNS penetration in humans in the Phase 1 MAD cohort. It’s right there in the deck. Healthy volunteers showed clear CSF exposure of GT-02287 — 3.1 ng/mL on average, which matches the levels that worked in rodent models. The rodents actually had 2–8x higher drug levels in actual brain tissue than plasma, which is exactly what you want for a CNS drug. So no, they’re NOT “waiting to find out” if it crosses the BBB. They already know it does. The upcoming readout isn’t about basic penetration; it’s about confirming that long-term dosing in Parkinson’s patients produces consistent CNS levels and that those levels tie into: GCase activation, lysosomal + mitochondrial restoration, sphingolipid reduction and alpha-synuclein-related biomarkers On top of that, they’ve already shown functional improvement by Day 90 in the Phase 1b group. That alone sets them apart from pretty much every symptomatic PD treatment and most early “disease-modifying” attempts. And yes, other companies are working on Parkinson’s. That’s not the point. AskBio’s gene therapy is a totally different approach which is invasive, risky, and expensive. GT-02287 is an oral small molecule that restores GCase function across the entire disease cascade. If you actually compare mechanisms, they aren’t even in the same category. So the idea that Gain is behind or “doesn’t know” whether the drug hits the brain is just wrong. They already proved CNS exposure. What they’re about to share is the translation whether that CNS exposure, in actual PD patients, lines up with biomarkers and functional benefit. That’s the data big pharma waits for before writing a check.

Equal_Dragonfruit_39

You can run the numbers yourself. It doesn’t matter what the total LM market is today. This test detects more accurately and more quickly which is what plans care about for risk adjustment. This test detects more quickly, so a lower ETP is needed. The higher cost of this test is justified with the risk adjustment payments and improved outcomes. LM is currently significantly underdetected because the traditional CSF assays are not accurate. Do you have a source on the $1.5b? Single hub does not limit expansion, many operate on a single lab basis. But they will need to be able to handle volume there. Competition is real - Belay Diangostics is one and I hadn’t heard of Tempus, but it looks valid they just aren’t commercialized. The $528m is not a set number it is a range. You can adjust the formulas how you’d like. I did provide a picture that shows how the revenues lo under different coverage rates.

OldRate5407

The market size and revenue projections are grossly overestimated. Market Size : The total LM market (diagnosis and treatment) is about $1.4 billion. The diagnostics portion is 20-30% of that, making the diagnostics market around $350 million. Since this includes MRI, the specific CSF diagnostics market is closer to $150-200 million. Competitive Landscape : Despite being a leader in LM diagnostics, the company's single hub in Texas restricts nationwide expansion. It is also likely to be outmatched by its competitor, Tempus, in terms of sales and network reach. Realistic Revenue : Based on a 20% m/s, a realistic revenue estimate is $40 million. The original projection of $528 million is unjustifiably high.

Excellent-Cut6477

I'm sitting at 22,222 shares and average cost of .395. The UHC agreement is a big deal. I plan on holding for the next year and will take profit gradually to offset my basis. I may even add to my position. There are many reason to be bullish on the stock. CNSide has a much higher senstitivity and better at detecting cancer than CSF cytology. I've done my own DD and feel good about my decision. Is it a value at it's current price in light of what this stock will likely do in the next 12 months and next 3 years? In my opinion it is. The key here is CNSide can provide meaningful revenue in 2026 making it less speculative than a biotech that hinges soley on trial data and FDA approval. That said, Reyobiq, when approved, will be the perfect match with CNSide diagnostic and testing. Not to mention the orphan drug designation it was granted. In light of the UHC agreement (and the impact it will have on bringing other insurers on board) will most likely result in NASDAQ granting another extension even if they fall short of addressing the Nasdaq delinquency (which they may not be short of the MVLS requirement at this point, but they are the share price of $1).

te7037

"**CNSide Diagnostics**, a wholly-owned subsidiary of **Plus Therapeutics, Inc.** (NASDAQ: [PSTV](http://finance.yahoo.com/q?s=PSTV)), has signed a national agreement with **UnitedHealthcare insurance company**, a unit of **UnitedHealth Group Inc.** (NYSE: [UNH](http://finance.yahoo.com/q?s=UNH)). Effective September 15, the agreement covers over 51 million people throughout the United States, providing the CNSide Cerebrospinal Fluid (CSF) Tumor Cell Enumeration [laboratory developed test (LDT)](https://www.benzinga.com/general/health-care?utm_campaign=partner_feed&utm_source=yahooFinance&utm_medium=partner_feed&utm_content=site&nid=47861805). Under the partnership, Plus Therapeutics Inc. (NASDAQ:PSTV), through its subsidiary CNSide Diagnostics LLC, will provide CNSide Cerebrospinal Fluid Tumor Cell Enumeration laboratory developed test (LDT) to over 51 million people in the US. "

fashionrepsuser2008

Trial data coming from their ReSPECT-LM brain cancer program later this year (conference updates in August). • Diagnostics launch — their CNSide CSF assay is rolling out in Texas in late 2025, with more states after. • FDA/regulatory — possible End of Phase 1 meeting and updates on pediatric brain cancer IND. • Funding — already backed by a $17.6M CPRIT grant, and just restructured financing to cut dilution risk.

Away-Personality9100

You bought BINI? ... In my past, I lost my account two times. And I started again with new capital. Since 2012, I trade only CSF and CC and I am finally in profit. 🙏

Mongoose_Jazzlike

PSTV reports that since 2020, more than 11,000 CNSide tests (across its CSF assay platform, presumably including enumeration and possibly other analytes) have been performed at U.S. cancer institutions. Publicly available information suggests the following pricing structure for the CNSide CSF Tumor Cell Enumeration (TCE) test: Under the licensing agreement, Biocept will charge $6,000 per enumeration when Plus Therapeutics (pre-technology transfer) has the workflow done in Biocept’s CLIA lab. After technology transfer, the agreement allows for a sliding-scale fee starting at $2,800 per CNSide test. So, the cost for one test (CSF tumor cell enumeration) is likely to fall in the range of $2,800 to $6,000 depending on the stage of technology transfer and service provider. At the top end of the ranges, that's 24mil annually (6k x 4k). That's pre-this deal for context.

Pharmalucid

The only way they have shown any reduction in oligomers in CSF is through broad smears of western blots.They literally take a giant chunk of the entire lane, jack the contrast, and say that nonspecific blob is oligomers. It’s incredibly imprecise and I don’t think it is good science. Good luck

PenguinnBets

**Plus Therapeutics (NASDAQ:PSTV)** presented positive data from their CNSide® Cerebrospinal Fluid (CSF) Assay Platform at the 2025 SNO/ASCO CNS Metastases Conference. The retrospective analysis, involving **613 CNSide assays** from 218 patients across 5 institutions, demonstrated significant capabilities in detecting and monitoring leptomeningeal metastases (LM). Key findings include **67% detection rate** of CSF tumor cells, with notable observations of immunocytochemistry and FISH probe detection changes in patients with multiple CSF draws. The platform showed **2.8 times higher diagnostic sensitivity** compared to standard CSF cytology and influenced clinical management decisions in **over 90% of LM cases**. [https://www.stocktitan.net/news/PSTV/plus-therapeutics-presents-positive-cn-side-csf-assay-platform-0yh6wolqkrpe.html](https://www.stocktitan.net/news/PSTV/plus-therapeutics-presents-positive-cn-side-csf-assay-platform-0yh6wolqkrpe.html)

Decent_Yogurtcloset3

From today Plus Therapeutics (NASDAQ: PSTV) today announced positive results for its CNSide® CSF Assay platform, which in a large study achieved a higher detection rate and better ability to monitor tumor changes over time than standard methods. At the same time, the company has received a temporary postponement from Nasdaq to avoid delisting. They must document improved equity (min. USD 2.5 million) and raise the share price to above USD 1.00 for ten consecutive trading days by September 8, 2025.

Decent_Yogurtcloset3

From today Plus Therapeutics (NASDAQ: PSTV) today announced positive results for its CNSide® CSF Assay platform, which in a large study achieved a higher detection rate and better ability to monitor tumor changes over time than standard methods. At the same time, the company has received a temporary postponement from Nasdaq to avoid delisting. They must document improved equity (min. USD 2.5 million) and raise the share price to above USD 1.00 for ten consecutive trading days by September 8, 2025.

Freedom5567

Shorts nowadays are rampant unfortunately! This is all great news for the stock. Huge actually! And it gets downvoted! lol shorts are furious to see this news come out! This NCCN update sets the stage for PSTV’s “test + treat” model: • Test: CSF–tDNA liquid biopsy detects residual disease • Treat: PSTV delivers targeted therapy into the same fluid Downvoting is sometimes good! Means I didn’t waste my time here! lol it surely wasn’t the investors downvoting now was it! 😉 This is truly a thing of beauty for those that can grasp what is happening! Stocks are always a gamble but my odds here are way better here than any lottery! lol But seriously, I can’t yell this out LOUD enough! GL

Freedom5567

This NCCN update effectively sets the stage for PSTV’s “test + treat” model: • Test: CSF–tDNA liquid biopsy detects residual disease • Treat: PSTV delivers targeted therapy into the same fluid The market is being prepared before PSTV’s launch.

Worried-Angle6504

Confirmed Dates & Events August  7, 2025 — Annual (Virtual) Meeting of Stockholders at 9:00 AM Eastern Time. August 14–16, 2025 — SNO/ASCO CNS Metastases Conference in Baltimore, MD (Baltimore Waterfront Marriott). Within the conference: August 14, 2025, 6:15 – 7:15 PM ET — LM Educational Symposium hosted by Plus Therapeutics, titled “Reimagining Your Approach to Leptomeningeal Metastases.” August 14, 2025, 7:15 – 9:00 PM ET — CNSide Diagnostics Presentation (FORESEE study: CSF Tumor Cell Detection) by Dr. Priya Kumthekar in Grand Ballroom VI. August 15, 2025, 3:25 – 4:50 PM ET — ReSPECT‑LM Trial Data Presentation (REYOBIQ safety and efficacy results) by Dr. Andrew Brenner in Grand Ballroom As you can see there's lots of catalysts coming yet I think even if a RS was to happen it doesn't matter at this point, you don't book out an entire hall for a conference to give BAD news!

Worried-Angle6504

Confirmed Dates & Events August  7, 2025 — Annual (Virtual) Meeting of Stockholders at 9:00 AM Eastern Time. August 14–16, 2025 — SNO/ASCO CNS Metastases Conference in Baltimore, MD (Baltimore Waterfront Marriott). Within the conference: August 14, 2025, 6:15 – 7:15 PM ET — LM Educational Symposium hosted by Plus Therapeutics, titled “Reimagining Your Approach to Leptomeningeal Metastases.” August 14, 2025, 7:15 – 9:00 PM ET — CNSide Diagnostics Presentation (FORESEE study: CSF Tumor Cell Detection) by Dr. Priya Kumthekar in Grand Ballroom VI. August 15, 2025, 3:25 – 4:50 PM ET — ReSPECT‑LM Trial Data Presentation (REYOBIQ safety and efficacy results) by Dr. Andrew Brenner in Grand Ballroom

Zestyclose-Storm-270

A lumbar puncture (spinal tap) is performed to collect a small amount of CSF, the clear fluid that surrounds your brain and spinal cord. This is much less invasive than brain surgery or a biopsy. No surgery needed for diagnosis or monitoring Faster, safer, cheaper than brain biopsies Enables early detection of tumors in high-risk patients Can track treatment effectiveness in real-time This technology is especially useful for cancers that metastasize to the brain or spinal cord, like lung, breast, and melanoma, or for hard-to-reach tumors.

No_Friendship386

You can tell this is posted by a Non-Science person. Because you don’t know what you talking about, don’t get me wrong I am long on PSTV. But your information is wrong and misleading 1. It’s CFS analysis, it’s already being done as cytology but this method of CSF analysis is more accurate and high s&s. So eventually it may become standardized rather than simple CSF cytology. 2. Leptomeningial cancer is not a difference type of cancer. It’s a metastasis from any cancer such as brain, lungs, ovarian, any cancer can metastasis to spinal fluid and meninges. So far no treatment except symptom relief, RYEOBIQ is targeting that. Having said that it has potential to reach 500 million market cap, that’s 7 dollars.

Rare-Dragonfruit-246

$PSTV HERE BOYS! Its official! NCCN adding CSF - CT DNA. Obviously they cannot add the company names. Guess who does CSF CT DNA testing? Just google it. Only one company! PLUS THERAPEUTICS!!

Rare-Dragonfruit-246

$PSTV – Legit sleeper biotech w/ real near-term catalysts Trading under $1 and flying under the radar. Just filed to WITHDRAW their S-3 offering – which means no dilution for now. That alone is rare in this market (IXHL anyone?). Here’s why I’m watching: ✔️ They specialize in targeted radiotherapeutics for rare, aggressive cancers – like glioblastoma (GBM) and leptomeningeal metastases (LM). Big unmet needs. ✔️ Lead candidate Rhenium-186 is in Phase 1/2 trials for multiple indications and has Orphan Drug + Fast Track designation. ✔️ Key upcoming catalyst: REYOBIQ (rhenium Re186 obisbemeda) - (ReSPECT-LM) Phase 1 data to be presented at SNO/ASCO on August 15, 2025. Phase 2 trial initiation planned. 3 ✔️ Key upcoming catalyst 2 : CNSide - (FORESEE) Presentation due at SNO/ASCO CNS on August 14, 2025. Trial data reported that the trial achieved its primary endpoint, demonstrating that CNSide influenced treatment decisions in over 90% of cases, surpassing the 20% primary endpoint target, noted August 13, 2024. Additional trial data demonstrated enhanced sensitivity in detecting tumor cells (80%) vs. CSF cytology (29%) in patients with LM, noted November 22, 2024. ✔️ Recently granted FDA Rare Pediatric Disease Designation for LM – this opens up eligibility for a priority review voucher, worth $$$ if granted. ✔️ Clean cap table for now – no recent dilution, and they pulled the S-3. Either they’re confident in data or another non-dilutive funding route is coming. ✔️ Plus Therapeutics has restructured its $15 million equity financing to eliminate potential dilution of up to 1.5 billion shares. ✔️ Market cap is under $35M. One good PR and this thing could fly, like we’ve seen happen with other sub-$1 biotechs recently. Target: 1.8–4$ short-term if data is clean.

Rare-Dragonfruit-246

$PSTV – Legit sleeper biotech w/ real near-term catalysts Trading under $1 and flying under the radar. Just filed to WITHDRAW their S-3 offering – which means no dilution for now. That alone is rare in this market. Here’s why I’m watching: ✔️ They specialize in targeted radiotherapeutics for rare, aggressive cancers – like glioblastoma (GBM) and leptomeningeal metastases (LM). Big unmet needs. ✔️ Lead candidate Rhenium-186 is in Phase 1/2 trials for multiple indications and has Orphan Drug + Fast Track designation. ✔️ Key upcoming catalyst: REYOBIQ (rhenium Re186 obisbemeda) - (ReSPECT-LM) Phase 1 data to be presented at SNO/ASCO on August 15, 2025. Phase 2 trial initiation planned. CNSide - (FORESEE) Presentation due at SNO/ASCO CNS on August 14, 2025. Trial data reported that the trial achieved its primary endpoint, demonstrating that CNSide influenced treatment decisions in over 90% of cases, surpassing the 20% primary endpoint target, noted August 13, 2024. Additional trial data demonstrated enhanced sensitivity in detecting tumor cells (80%) vs. CSF cytology (29%) in patients with LM, noted November 22, 2024. ✔️ Recently granted FDA Rare Pediatric Disease Designation for LM – this opens up eligibility for a priority review voucher, worth $$$ if granted. ✔️ Clean cap table for now – no recent dilution, and they pulled the S-3. Either they’re confident in data or another non-dilutive funding route is coming. ✔️ Plus Therapeutics has restructured its $15 million equity financing to eliminate potential dilution of up to 1.5 billion shares. ✔️ Market cap is under $15M. One good PR and this thing could fly, like we’ve seen happen with other sub-$1 biotechs recently. Target: 1.8–4 short-term if data is clean.

wsb_moonshot

\[Off topic for a second\] I know many of you are burning the midnight candle spending way too much time bird-dogging the market so I have a helpful aid for you. [This is the best spill-proof coffee mug](https://www.amazon.com/dp/B0CSF3TLQF?ref_=ppx_hzsearch_conn_dt_b_fed_asin_title_1&th=1) for your your desktop that keeps coffee hot for hours.

Wendelah

Apologies, I should have been more clear about my source for the indicative cognitive effect. That specific comment is verbal overlay provided by the CEO in two follow-up interviews held today where he expanded upon the results that were posted last week. In the press release they're more careful in their phrasing, basically saying that they "see an apparent dose-dependent positive trend". In the interviews, he clarifies that this dose-dependent positive trend was in fact complete stabilisation for certain patients. The interviews are unfortunately in Swedish, but I'll link them below including time stamps. Interview 1 (2:30-3:40): https://www.alzinova.com/news/carnegie-interview-with-our-ceo/ Interview 2 (2:40-4:20): https://www.alzinova.com/news/ceo-interview-by-redeye/ Regarding the biomarkers, at the moment we only have the first interim results from this spring, where they showed positive trends in all relevant CSF biomarkers. More granular data will unfortunately not available until the full study wrap-up, I'm afraid. Link to the AAIC poster where this was covered: https://alz.confex.com/alz/2024/meetingapp.cgi/Paper/95440 I expect the full analysis from A1+B to be available in Q1 with more commentary, including biomarkers for part B. The full dataset from the phase 1b study (all legs) is expected for Q2'25.

nezroy

15% from the 28 day trial. The 6-month P2 open label CSF markers on 25 patients showed a 84% increase in Ab42

Hl_IM_MR_MEESEEKS

You know it CSF 🫵😮‍💨☝️

Nebula_Whinch

I only made the comment for historical purposes. So i can come back later. @Twit_Ripper - As a Reminder P2 - 216 patients. 47% with Cog improvement and 23% stabilized after 12/mo P2 - after 24 mo - 90 requested to enter the P2 OLE, BTW there were 155 who were in the CMS so 90/155 = 58.7% 2 Large P3, both received SPA (how many SPA's does the FDA give out per year and this company got two! The answer is around 12 each year out of the tens of thousands of drug trials) First P3 fully enrolled in Sept of 2023, last patient will complete dosing Sept/Oct of this year and data will be released Q4. Second P3 fully enrolled in Oct of 2023, trial will be completed by mid 2025 (even if it is converted to a confirmatory trial). ALL P3 patients were screened by plasma Biomarkers as a condition of entry into the trials. 25 to 60 of the P2 patients received biomarker screening (CSF). Patients who had Biomarker screening in the P2 had a mean cog improvement of -4.96 pts! 71%+ of the P3 Patients are early to mild patients while 133/216 P2 patients were mild or 61.5%. Mild 24mo. 0% decline. I really hope you short this stock through Q4 it’s a brilliant idea if you are so sure of yourself. Thank you.

KeyIntroduction8735

It is literally washed by CSF

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Dystempre

While having people in what seems to be a cash equity sub opine on medical progress as if they are experts is entertaining… > chronic poor sleep quality (your brain “cleans” itself in deeper phases of sleep) This is hardly a ground breaking opinion and it certainly isn’t one you came up with; this has been opined on since before 2013. See below “ While the brain sleeps, it clears out harmful toxins, a process that may reduce the risk of Alzheimer's, researchers say” - NPR/Medical News Today/Nih/Harvard Medical etc. It’s going to come out? It’s already been “out” for a number of years. There was a study that proved that CSF flushes the brain of impurities and debris whilst you sleep - Boston Uni 2019 > It’s gonna come out in the next decade that it’s due to various things like chronic poor sleep quality (your brain “cleans” itself in deeper phases of sleep), repeated head trauma, drug use, poor diet (ultra processed foods etc). Sources please (other than your “breaking news” about CSF cleansing the brain)? Without sources you are just talking out of your ass To be clear, I’m not saying your opinions are incorrect, you just need to differentiate between what you know and what you think

Phonemonkey2500

Dude, you're fucking up the narrative! How is Aladdin supposed to maintain complete control of the markets when some Yahoo Retard is out on Reddit spittin' facts?! Larry Fink's Executive Secretary's Assistant's Junior Secretary's 1st Dumpster Helper will be contacting you in the morning to arrange for kidney extraction. Abigail Johnson will oversee the procedure. She may require some of your CSF, as stipulated in your signed contract. Get it together, you know we billionaires gotta stick together when the proletariat rises up!

Both_Presence_5163

Maybe it’s a CSF leak

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SPAC_Time

FirstMark Horizon Acquisition Corp FMAC FMAC.WS [signed non-redemption agreements](https://www.sec.gov/Archives/edgar/data/1822219/000121390022011363/ea156617-8k425_firstmark.htm) with "certain accredited investors", in essence lowering the cost basis for those investors' 2.4 million shares to about $8.50 per share, in exchange for them not redeem at next week's meeting. That was likely done to make sure the minimum cash condition would be met and the deal could go through. Tim Horton's China SLCR SLCRW did something similar this morning. They signed [new subscription agreements](https://www.sec.gov/Archives/edgar/data/0001826553/000110465922031790/tm2125996d19_8k.htm) for 9,450,000 ordinary shares of THIL (the “PIPE Shares”) at a price of $10.00 per PIPE Share; however SLCR also "will issue to certain PIPE Investors in the aggregate, an additional 600,000 ordinary shares of THIL and 1,200,000 warrants to purchase ordinary shares of THIL at an exercise price of $11.50 per share" to those subscribers. That lowers the effective price of the PIPE shares to $9.40, ***not counting*** the value of the warrants. The deal gets better for Shaolin Capital Management LLC, who are purchasing up to 5 million of those PIPE shares. According to the [Equity Support Agreement](https://www.sec.gov/Archives/edgar/data/0001826553/000110465922031790/tm2125996d19_ex99-2.htm) , Shaolin gets 10 cents per share returned at closing; 40 cents per share returned for the first 1/3 of the total shares returned 85 calendar days plus 25 trading days after the closing; 60 cents per share returned for the second 1/3 of the total shares returned 145 calendar days plus 25 trading days after the closing; and 90 cents per share returned for the final 1/3 of the total shares returned 235 calendar days plus 25 trading days after the closing. ( That's if I'm reading the Equity Support Agreement correctly, it's a pretty dense agreement, but think that's correct ). Plus: "Tims China has executed a letter of intent for a $100 million committed share facility (“CSF”) with a global financial services firm (“Investor”). The facility will be governed by an Ordinary Share Purchase Agreement, under which the Company will have, in its discretion, the option to sell up to $100 million of its ordinary shares to Investor over a 36-month period". Notice it doesn't specify the *price per share* for those $100 million committed shares. Nothing in the 8-K filing outlining the terms of the letter of intent, other than it exists for a $100 million equity sale over 36 months, at Tim Horton China's discretion. At least in the case of SLCR, the sponsors are forfeiting 50% of the Sponsor’s shares and warrants, and the pre-transaction equity value of THIL was reduced from $1,688,000,000 to $1,400,000,000. TL/DR: SPACs are being forced to find creative ways to finance the deals and get them completed.

potatojoey

So much of the data in the preclinical work for this compound is literally western blots. They do shady shit like this... Lindsay Burns of Cassava Biosciences comments on Alzforum "A correction: In 2020, CSF data were not reanalyzed; backup CSF samples were reanalyzed, producing new data that did not show unexpectedly large changes over one month in placebo patients as the prior analysis did, nor improvements in some biomarkers concurrent with worsening in other biomarkers in the same patients. In short, the second analysis showed high correlations between biomarkers in changes from baseline. The first analysis showed no correlation between biomarkers in change from baseline (r=0.06 on average in placebo only)." The data is shit, no one gives a fly fucking about acetylcholine receptors, there is no omic data to support a role for FLNA, the doses used in preclinical data are nowhere near the Ki. You don't know anything about Alzheimer's disease. You are trying to scam people. You're a fraud, this company is a fraud. No one at all anywhere in this company or on its board is even remotely respected in the field

wavemasterz1

Reports from SAVA also had increase beta-amyloid in patients after 6 months. You can argue association doesn't equate to causation but I'm going to trust Nature articles stating that high beta-amyloid levels are theorized to be toxic and may be related to a cause of Alzheimers. There are also issues with the results as they change the baseline for the ADAS-cog. And the CSF markers for decreased neuro-inflammation has been done before but again you can't associate the decrease inflammation to cause improved disease progression. You can argue if the drug improves cognition that's all that matters. But for me, when so many things smell fishy especially within a small 9 person team, I'm out.

Level-Possibility-69

I would hate to be a CEO of one of those companies. They are doomed by the Cramer Shit Finger (CSF) touch.

gopoohgo

*eyes my portfolio* I can't guarantee my brain and CSF aren't prion-riddled oatmeal

Pretend_Vanilla_5080

Neutropenia has been shown to be associated with solid tumors especially breast cancer, as about 25% of breast cancer patients develop neutropenia. Lyman and Wilmot (2006) and Wolf et al. (2005) found that among patients with solid cancer, breast cancer patients had the highest risk for developing severe neutropenia and febrile neutropenia during the first cycle of chemotherapy. Due to the neutropenia, 40% of the breast cancer patients had the chemotherapy delayed and about 25% had their chemotherapy treatment doses reduced. The possibility of breast cancer patients to develop neutropenia at point during chemotherapy was 78%. A study in mice has shown that G-CSF may decrease bone mineral density. Combination of drug is said improve the quality of life, reduce bone pain. The treatment is said to prevent Grade 4 neutropenia within the first cycle of chemotherapy in solid tumor. The design is fitting. The only flaws I saw was the sample size.

TheCampingComedian

BeyondSpring Seeks Nod For Combo Treatment In Chemotherapy-Associated Toxicity Company: BeyondSpring Inc. (NASDAQ:BYSI) Type of Application: chemotherapy-induced neutropenia Candidate: plinabulin + G-CSF Combination Indication: NDA Date: Nov. 30 Plinabulin. in combination with granulocyte colony-stimulating factor, is being studied for the prevention of chemotherapy-induced neutropenia Each year in the U.S., 110,000 patients receiving chemotherapy are hospitalized after developing CIN, a severe side effect that increases the risk of infection with fever. It isn’t a cure for lung cancer…

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Good_Homework9096

CRTX is out today. They failed PH2/3 readouts. This is good news for SAVA, CRTX PH1 biomarker reading is so little, can't compared with SAVA. Especially CRTX did not have the T-tau, P-tau181 CSF biomakers in their pre-PH2/3 trials.

commiebits

I gave the PDF a read and it was good to see there were no dropouts, but they didn't give the reason why a patient didn't do the CSF catheter (I guess maybe it's PPI?). They also seemed to use the PCR in this slide to only show correlation but not to show any improvement delta. The RANTES info seemed to be completely omitted, as well as any biomarker plots, in the youtube's slide deck. The overlap in ranges for MMSE and CANTAB were admitted in text, so I appreciate the honesty, but I guess let's just cross our fingers on the next batch of results.

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WestTexasCrude

Ok, before you apes go full fucking retard on $SAVA or talk about "hit pieces" or what the fuck ever. Listen up: The link the OP posted did show a placebo control group but the statistical power of the study is ridiculously LOW. There were a total of 64 patients total. TOTAL. Sixty four. Thats less boy friends than y'alls' wives have. This study is underpowered PERIOD. Now, that being said TWO of the patients in one of the drug arms didnt have the med present in the samples, likely meaning they didnt even take the drug. Furthermore, the end point of the study had a minimal amount of patient oriented outcome data. Meaning that they could find the spice melange in their CSF but that dont mean shit. What matters is that gramps is doing integral calculus or is teaching the kids how to use a slide-rule like the olden days. They didnt look. They administered a "mini mental status exam" that is basically a quick bedside test to asses the likelihood of whether or not dementia is present. The granularity of an improving test is NOT meant to test the progression or regression of the disease state itself. Again, this is a stastically insignificant and underpowered study that did NOT appear to me to prove superiority to placebo. But the lack of power is the reason. This means that no conclusion can be made for or against. These people's brain mass are gone, never to return, much like ours. But, fuck it. Buy your calls.

Jaffrojones

SAVA up another 9%. Reason below... On Monday, July 26th, at approximately 10 am ET, scientists for Cassava Sciences will show a poster presentation at AAIC, titled “SavaDx, a Novel Plasma Biomarker to Detect Alzheimer’s Disease, Confirms Mechanism of Action of Simufilam”. On Thursday, July 29th, at approximately 11 am ET, simufilam will be featured in a live podium presentation at AAIC, including a brief Q&A session. This oral presentation will announce results of an interim analysis on safety and cognition for the first 50 patients with Alzheimer’s disease to complete 9 months of open-label treatment. Scientists for Cassava Sciences will also present biomarker data analyzed from cerebrospinal fluid (CSF) collected from 25 study subjects at baseline and again after completing 6 months of open-label drug treatment Cassava Sciences plans to launch two Phase 3 clinical trials evaluating the efficacy of simufilam, its investigational oral treatment for Alzheimer’s disease, in the second half of this year. The decision follows the successful completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for simufilam. The FDA agreed to key elements of the planned Phase 3 trials, such as the outcomes that will measure treatment effectiveness. FDA officials also agreed that findings from these Phase 3 trials, in combination with previous trial data, would be sufficient to show evidence of clinical efficacy for simufilam as an Alzheimer’s treatment.

Substantial_Ad7612

A big part of my job in medical affairs at a global pharma company is to read and interpret clinical trials. Maybe that makes me even less credible to some 🤷🏼‍♂️. I’ve seen a lot of hype around this company and it could pay off, especially in the short term. That being said, there is a bear case that I haven’t really seen presented. Bear case - small trial (<500 patients in the mITT), barely met the primary endpoint (p=0.041), and not published in a reputable journal (not peer-reviewed). Other attempts to target GM-CSF have not panned out. This is an unproven strategy and the FDA may have trouble approving based on LIVE-AIR. Potential for pipeline is good but that isn’t what is driving the value right now. Do or die on the COVID indication.

inquisitorthreefive

I had posted a version of this elsewhere in the thread, but it should really be a top-level comment so I've expanded and reposted it. This is not just a COVID play. There's much more to Lenzilumab than COVID. The links I'm posting are literally the first I'm finding off a simple google search, but there's more and better to be had. It was originally meant to treat certain types of leukemia. It's still in Phase 2 for that, if memory serves. https://www.ashclinicalnews.org/news/from-the-blood-journals/written-in-blood/lenzilumab-demonstrates-clinical-benefit-patients-chronic-myelomonocytic-leukemia/ However, it binds to GM-GSF, which is the primary driver of cytokine storm. Prior to COVID, testing began with CAR-T drugs to reduce the major obstacle for high doses of CAR-T, cytokine toxicity. That was phase 1, phase 2 is in the works with multiple CAR-T drugs, but the issue spans the entire family. https://www.healio.com/news/hematology-oncology/20210422/lenzilumab-before-cart-induces-high-response-rates-without-severe-toxicities Finally, it is being tested for graft vs host, since it turns out that cytokines are responsible for that killing you, too. Phase 2 being planned. https://www.globenewswire.com/en/news-release/2019/10/08/1926409/0/en/New-Blood-Advances-Publication-Supports-Humanigen-s-GM-CSF-Neutralization-Strategy-with-Lenzilumab-in-GvHD.html Additionally, Humanigen owns the patent for CRISPR Knockout of GM-GSF, which would make CAR-Ts safer and more effective, so other companies will either need to license the GM-GSF KO or patients would need Lenzilumab for higher CAR-T doses. Even if the EUA is not approved, this is a drug on the cutting edge of oncology and other areas of medicine that should be incredibly exciting. So exciting that Astra Zeneca's VP of Oncology, Adrian Kilcoyne, left AZ to take a job at HGEN. Further, Humanigen's pipeline looks really good. There's Ifabotuzumab, which is geared to solid tumors and has completed phase 1 for Glioblastoma Multiforme, which is currently considered to be incurable. It works by attacking the tumor's vascular structures, which have similarities in other forms of cancer as well. https://www.biospace.com/article/releases/humanigen-announces-positive-results-from-phase-1-study-of-ifabotuzumab-in-glioblastoma-multiforme/ Finally, there's a CAR-T of their own in the works along with a slew of useful patents being developed.

__nerman

I think OP left out the fact they did a public offering after P3 results. That was a major part of the decline after the huge run up. BUT, they used that money to spend $50M in Q1 and $50M in Q2 to develop drug. The SP would no doubt be higher today if not for that offering. It was 5M shares at 18.50 gobbled up by institutions. Now we have a PM price of $17.30. I've been in for 9 months. Most are in shares due to the high IV and the games being played with options over the last few months. The ones playing the games are almost out of firepower though. I'm waiting to buy options after July 16th OPEX. I think they may be able to control it another month if we don't see approval by the 16th. But again, I'm in with shares so I'm not missing the boat if approval is before July 16th. The UK is as exciting as the US in regards to approval...if not more. Major studies about GM-CSF and Covid-19 have been published out of the UK this year. NICE (National Institute of Health & Care Excellence) actually reached out to HGEN and they applied for EUA there immediately after the US. With the variant raging in the UK we could possibly see a faster approval there. The ultimate reason I've been in this long is management. They've hit every milestone they've put on the calendar over the last year. From joining Nasdaq (Russell last week) to completing trials and getting data together and applying for approval they've done it. There are no games from management and no pumps.

inquisitorthreefive

There's much more to Lenzilumab than COVID. The links I'm posting are literally the first I'm finding off a simple google search, but there's more and better to be had. It was originally meant to treat certain types of leukemia. It's still in Phase 2 for that, if memory serves. https://www.ashclinicalnews.org/news/from-the-blood-journals/written-in-blood/lenzilumab-demonstrates-clinical-benefit-patients-chronic-myelomonocytic-leukemia/ However, it binds to GM-GSF, which is the primary driver of cytokine storm. Prior to COVID, testing began with CAR-T drugs to reduce the major obstacle for high doses of CAR-T, cytokine toxicity. That was phase 1, phase 2 is in the works with multiple CAR-T drugs, but the issue spans the entire family. https://www.healio.com/news/hematology-oncology/20210422/lenzilumab-before-cart-induces-high-response-rates-without-severe-toxicities Finally, it is being tested for graft vs host, since it turns out that cytokines are responsible for that killing you, too. Phase 2 being planned. https://www.globenewswire.com/en/news-release/2019/10/08/1926409/0/en/New-Blood-Advances-Publication-Supports-Humanigen-s-GM-CSF-Neutralization-Strategy-with-Lenzilumab-in-GvHD.html Additionally, Humanigen owns the patent for CRISPR Knockout of GM-GSF, which would make CAR-Ts safer and more effective, so other companies will either need to license the GM-GSF KO or patients would need Lenzilumab for higher CAR-T doses. Even if the EUA is not approved, this is a drug on the cutting edge of oncology and other areas of medicine that should be incredibly exciting. So exciting that Astra Zeneca's VP of Oncology, Adrian Kilcoyne, left AZ to take a job at HGEN.

Came_to_name_a_puppy

Excellent job, you covered the company very well. I hope others will see this and decide to dive deeper. I have been adding shares for over a year here. I think buyout is probably the most likely outcome, but if not this company is well positioned on thier own to be extremely successful. Anyone looking should pay attention to Patents in GM-CSF Supression and it's roles in GVHD and Car-T .

jmaldana7

Casino also has “No” in it. Which I’ve never said before. CSF to the moon.

dickdaddyjrexttreme

I made a shot post earlier about Plinabulin and its parent company B Y S I. Plinabulin is the companies main drug is Plinabulin, originally studies as a chemotherapy drug for non small cell lung cancer. During the studies it was noted to have an immuno protective effect as well, this immuno protective effect will be the main money maker for the drug with the chemotherapy aspect being a free lottery ticket attached. Chemotherapy induced neutropenia protection (Protective 1 and Protective 2)- Last fall, the company released the top line results of the CIN prevention trials, protectives 1 and 2 which showed a reduction of CIN by 33.8% when combined with the current standard of care treatment G-CSF. Until the recent discover of plinabulin, no significant improvements in CIN prevention have been made in 30 years. The cost of CIN is enormous, representing up to 29.1 billion dollars a year. > "91,560 adults and 16,859 children with cancer were treated at a hospital because of neutropenia. The total cost for adults being hospitalized for cancer-related neutropenia was $2.3 billion, and $439 million for children. That was about 8% of all cancer-related hospital costs for adults ($27.5 billion) and 27% of all cancer-related hospital costs for children ($1.6 billion)."\* https://www.cdc.gov/cancer/dcpc/research/articles/neutropenia.htm#:\~:text=91%2C560%20adults%20and%2016%2C859%20children,and%20%24439%20million%20for%20children. The mounting costs of CIN in chemotherapy use bodes well for insurance approval of plinabulin. If the drug can decrease indicdence of CIN by 33.9% it will save payers 10 billion dollars for a significantly lower cost, passing one of the major barriers to adoption of new drugs. Some quick and dirty math can be used to create an extremely conservative valuation for the market of plinabulin in CIN use. Lets just take the most conservative approval in terms of the patient population that is allowed to be treated by plinabulin and run some rough price estimates. Lets say is is only approved to be combined with C-GSF in breast cancer patients and no other and remove China from the population since the company only owns 51% of the rights in China. There are roughly 290,000 cases of breast cancer a year with 50,000 requiring chemo, that will be our target population. Patients tend to get about 3 cycles of chemo when its needed, so 50,000 x 3 doses. C-GSF, a 30 year old drug makes 6,500 a dose, 19500 a patient. In total about 1 billion a year. Conservative estimate, lets say the brand new drug plinabulin gets 6,500 per dose, 1 billion a year on this extremely conservative patient population. Taking another conservative estimate, 30% of those 50,000 patients will receive it, personally I think it will be standard of care to combine it with every dose of G-CSF but lets be conservative, it puts revenue at 300 million a year, for a company valued at 400 million. 3X peak sales for company valuation (again conservative, biopharm sometimes uses 4-5x peak sales) places an estimated valuation at 900 million, so more than double the current value. The beauty of plinabulin for CIN prevention is that it is well underway for FDA approval in both the US and China. In China it received priority review on Tuesday which will be officially announced following the end of the one week period for public discourse. See the image attached in the post. https://stocktwits.com/Gozira/message/328976015 . Plinabulin was submitted for FDA approval March 31 so a response is expected by June 1. Plinabulin received breakthrough drug status following prospectives 1 and 2 and will likely receive priority review in the US as well, slating FDA approval at <6 months from June 1. This sentiment was echoed on the conference call as the company stated approval was likely by the end of Q4 with the commercial rollout of the drug starting after the holiday seasons. The last stock offering was Done last winter, on the conference call the CEO stated at their planned rate of cash burn they planned on being able to begin sales of the drug before another offering would be needed, potentially in Q1 of 2021. The Chemotherapy Lotter Ticket- The bank price targets ranging from 25$-45$ state they only price in the CIN use of the drug, yet plinabulin was originally studied for its anti cancer uses. The chemotherapy phase 3 study Dublin-3 is currently underway and the results are planned to be reported mid summer 2021. The possibility of a positive phase 3 trial for NSCLC has not been priced in and would cause a massive, quick jump in the price. The possibility was discussed between the BOA analyst and the CEO at BOA fireside chat yesterday. https://www.chartmill.com/news/BYSI/globenews-2021-5-10-beyondspring-to-present-at-the-bank-of-america-securities-2021-health-care-conference-on-may-13-2021?utm\_source=stocktwits&utm\_medium=pressRelease&utm\_content=BYSI&utm\_campaign=social\_tracking Although the chances of a strong anti cancer response are relatively low, showing any anti cancer benefit at all would be amazing as it would theoretically help with every chemo treatment plinabulin will be added for the immune support. The anti cancer benefit would speed adoption. Upcoming Catalysts Plinabulins parent company was recently accepted to present 4 papers at ASCO, the American society of clinical oncology's yearly conference. In the past this has bode well for smaller biopharm companies as a way to raise awareness and has often resulted in drastically increased stock prices, a phenomenon dubbed the ASCO effect. https://www.streetwisereports.com/article/2012/05/03/what-is-the-asco-effect.html They will be presenting the full data on Protectives 1 and 2 as well as presenting the data on plinabulins reduction of bone pain, a common complaint of patients on G-CSF. June 1 we should see a response by the FDA for approval of the submitted NDA as well as probable priority review. May 20-25 we will see the close of the public discourse period for review in China and announcement of official priority review for the drug in China. Mid summer we will see the results of the Dublin-3 lottery ticket. Seed Therapeutics Subsidiary The parent company B Y S I also fully owns SEED therapeutics, a company focused on creating "molecular glue" to denature harmful proteins. They have an 800 million dollar deal in place with Eli Lilly, which provides even more base value to a company with a market cap of only 383 million For WSBs obsession with short interest The company is currently heavily shorted following the bleed out of biopharm over the past three months, with SI climbing to 10.77%, this should add a nice amount of powder to the keg if any of the upcoming catalysts catch or will help to raise the SP as the company progresses into a revenue generating company Q1 2022 TLDR: Biopharm company with a novel drug designed to prevent chemotherapy induced neutropenia, the stock price has been battered down the last 3 months with the bleed of the biopharm market but a catalyst rich near term future will help to break from XBIs downtrend. The company comes with 2 free lottery tickets in the form of an anti cancer study and its SEED Therapeutics subsidiary. Bank PT ranging from 25-45, potential easy double in a few months. Position 8,097 shares at 13.48 July 21 Strike 17.5, 20.0, 25.0

dickdaddyjrexttreme

For valuation a quick look can give some dirty numbers. Total breast cancer cases in the US, about 280,000. Now an estimate for how many will receive chemo we can say roughly half, although I'm sure a more exact and uptodate number can be pulled, https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21565. Lets say140,000 are receiving chemo, pre Covid NCCN guidelines stated only high risk patients received prophylactic G-CSF, however with the advent of Covid patients in the intermediate risk group can receive it as well. It is hard to determine if the guideline will revert, but based on studies it does seem to be the more cost effective solution, so hopefully it stays. https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.29\_suppl.73 About 1/3 are high risk patients, another 1/3 are intermediate risk patients. Being conservative lets take 1/2 of the a140,000, 70,000 per year. In the conference call the CEO stated 70% of oncologists were interested, so lets take 70% of that, using 50,000 out of the 280,000 breast cancer patients as our market. Using the price of G-CSF as a stand-in, it would still put the yearly revenue over the current price of the market cap. A market cap of 2-3x revenue is a 3-4X return on the current SP. I can't find a number anywhere for the total number of breast cancer patients a year that receive Filgastrim currently but I'm sure it exists in either a conference call or company paper for companies that produce their version of it. That would be the best bet for the most accurate market size of Plinabulin. Edit: I believe the goal of their NDA is for approval in all solid tumor chemo regimens that G-CSF is currently used in, breast cancer is just what their protective studies measured due to the prevalence.

IvanThinking

Hop on board, this should soar today. \- Phase 3 GENESIS study in stem-cell mobilization (SCM) demonstrated highly statistically significant positive results across all primary and secondary endpoints - \- \~90% of patients in treatment arm underwent transplantation following only one dose of Motixafortide and only one apheresis session; potentially positions Motixafortide + G-CSF to become new standard of care in this indication - \- Company proceeding with activities in support of NDA submission targeted for H1 2022 - \- Management to hold conference call today, May 26, at 10:00 am EST - TEL AVIV, Israel, May 26, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the quarter ended March 31, 2021 and provides a corporate update.

RichSteps

This post mentions: **$CDC, $HTM, $BYSI, $CSF, $GSF** /u/AWAS666's account was created **5 years ago**. It has **1157** comment karma and **1178** link karma. ----- ^You ^may ^see ^tickers ^you ^didn't ^mention ^-- ^I'm ^casting ^a ^wide ^net ^because ^y'all ^don't ^always ^$TAG ^your ^ticker ^symbols. ^This ^was ^an ^automated ^response. ^If ^you ^have ^feedback, ^please ^reply ^to ^this ^comment ^or [^(send me a message)](https://www.reddit.com/message/compose?to=RichSteps&subject=bot%20feedback)^.

TheRealBeardedDonut

BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today announced positive top-line results from the Company's GENESIS Phase 3 trial evaluating its lead clinical candidate, Motixafortide, in combination with granulocyte colony stimulating factor (G-CSF, the standard of care in this indication), for hematopoietic stem-cell mobilization for autologous bone marrow transplantation in multiple myeloma patients. This immenses effort accomplished by the company made possible to win an important battle against cancer! Despite the great results, MMs and shorts once again have played this stock and punished the ones believing and investing in science to help people suffering from cancer. At some point we should all raise against this behavior and make them pay!! Time for short squeeze!! I will personally try to invest along the way holding everything single share until a Partner takes over!! \#FUCKCANCER #BLRX

RichSteps

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deSeingalt

Humanigen HGEN Nasdaq - Proprietary ***Humaneered*****®** monoclonal antibodies, designed to optimize antibody properties, show promise in prevention/treatment of cytokine storm induced by SARS-CoV-2 (COVID-19), chimeric antigen receptor T-cell (CAR-T) therapy and graft versus host disease (GvHD) by neutralizing GM-CSF which is up-regulated in these conditions. \- got that? biotech / 11-50 employees / California / public since 2001 << average price target $34 (43 high, 21 low) "buy" > > I don't have an opinion on HGEN

dragonfliesloveme

>Motixafortide + G-CSF Maybe it is reading that CSF \^ as if it’s a ticker? Lol, not sure just a guess

RichSteps

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Plenty-Appointment40

I did some of my own DD. This is posted in other threads but here.. EUA expected in 1-4 weeks. Shorts are trying to silence this company. Please do your own DD. I’ve been following this company for 6 months and I am in it for the long haul. this drug is immune to mutations of COVID-19, simply because it does not target COVID-19. This “in the weeds” company is called Humanigen and their therapeutic drug is called Lenzilumab. Lenzilumab, with other treatments including steroids and/or remdesivir, help prevent and treat an immune hyper-response, (cytokine storm). GM-CSF is responsible for activating macrophages and monocytes that contribute to disease severity, Mapping Severe COVID-19 in the Lungs at Single-Cell Resolution – NIH Director's Blog .[mapping severe covid](https://directorsblog.nih.gov/2021/04/13/mapping-severe-covid-19-in-the-lungs-at-single-cell-resolution/) Fully administered in one day, Lenzilumab improves patient SpO2 levels within the first 24 hours as shown by mayo clinic study and can prevent progression to invasive mandatory ventilation by 54%. It helps get patients out of the ICU/ hospital sooner, making more room for other critical patients in need. Humanigen Inc. - Humanigen Reports Positive Phase 3 Topline Results Demonstrating That Lenzilumab™ Improves Survival Without Need for Mechanical Ventilation in Hospitalized Patients With COVID-19[phase 3 results](https://ir.humanigen.com/news/news-details/2021/Humanigen-Reports-Positive-Phase-3Topline-Results-Demonstrating-That-Lenzilumab-Improves-Survival-Without-Need-for-Mechanical-Ventilation-in-Hospitalized-Patients-With-COVID-19/default.aspx) One item that may be a concern is the cost of the drug. However, the need for mechanical ventilation significantly increases the costs of COVID-19 care, as well as having a prolonged stay in the ICU. I’m not sure on Canada’s numbers in our healthcare, but in the States, it’s 5x the cost Mechanical Ventilation Adds 5X the Cost to COVID-19 Care | Premier (premierinc.com)[5x cost ](https://www.premierinc.com/newsroom/blog/mechanical-ventilation-adds-5x-the-cost-to-covid-19-care) The FDA has revoked EUA for Monoclonal Antibody Bamlanivimab because of its ineffectiveness against newer strains while being used for mild-to-moderate COVID-19 symptoms , FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab (govdelivery.com)[bam is bad](https://content.govdelivery.com/accounts/USFDA/bulletins/2cd68e3) Of the currently available vaccines with mutations on the rise and reduced efficacy against them, I believe that Lenzilumab can help save lives and solve multiple problems that we are currently facing. Such as, reduce need for invasive mandatory ventilation, immune to mutant strains, reduce hospital stay ie. More bed availability, fast reoxygenation response, fully administered in 1 day, cost savings on healthcare, etc. I want to put eyes on this because it seems that it’s getting silenced from HF shorts. So much amazing news. Again please do your own DD but I think this is a diamond in the rough.

Came_to_name_a_puppy

Company has been working with BARDA and NIH since October. They have mentioned in past calls they will look to provide 100K doses in 2021 and would be discussing stockpiling with Govt for future needs. It's really important to understand the role of GM-CSF in Covid ARDS which is very similar to Cytokine Release Syndrome in Car-T. They hold numerous Patents in it's application with Mayo Clinic. The shortsighted will say Covid is over, Vaccines make it so we don't need it, but the real value is in Car-T, Solid Tumors and GVHD. I've been holding for over a year, and read allot about them. It's most certainly worthy of Due Diligence time and efforts. In addition to EUA Application which is any day, I'd also keep an eye out for Perr Review of Phase III Data.

Doxy-Cycling

Right I understand. The example I was trying to suggest was that you’ve heard about G-CSF as the current gold standard for CIN even though you aren’t specialized in that area. But never heard about pina until now so you aren’t alone in not knowing what this drugs potential are and rightfully so cause we know statistically more drugs fail than get approved by fda. Therefore, I don’t think this approval is priced in just yet as it’s been pretty much flying under the radar.

dickdaddyjrexttreme

When combined its a bit over 50% more effective than G-CSF alone, which is a pretty nice improvement. They lay out some of the basics in the press release given out with the NDA filing. The application is based on findings from the phase 3 PROTECTIVE-2 trial (Study 106; NCT03294577), which showed that the combination of plinabulin and pegfilgrastim (Neulasta) was 53% more effective in reducing CIN incidence than pegfilgrastim alone in patients who were undergoing chemotherapy.2 The incidence of profound neutropenia was 21.6% with the combination vs 46.4% with pegfilgrastim alone (*P* = .0001) in patients with breast cancer who are undergoing a chemotherapy regimen comprised of docetaxel, doxorubicin, and cyclophosphamide (TAC). The combination also resulted in a 41% reduction in the risk of febrile neutropenia vs pegfilgrastim alone, based on a reduction of profound neutropenia. [https://www.onclive.com/view/approval-sought-for-plinabulin-plus-g-csf-in-united-states-and-china-for-prevention-of-cin](https://www.onclive.com/view/approval-sought-for-plinabulin-plus-g-csf-in-united-states-and-china-for-prevention-of-cin)

UncleT_Bag

CIN isn’t something I deal with in my specialty but if the standard therapy becomes G CSF + this drug then that would be pretty big. And to be fair I need to do some more thorough DD on the studies to see the design and the magnitude of the the therapeutic affect.

dickdaddyjrexttreme

Ill repost a short conservative market summary I replied to InB4uR >Lets just take the most conservative approval in terms of the patient population that is allowed to be treated by plinabulin and run some rough price estimates. Lets say is is only approved to be combined with C-GSF in breast cancer patients and no other and remove China from the population since the company only owns 51% of the rights in China. There are roughly 290,000 cases of breast cancer a year with 50,000 requiring chemo, that will be our target population. Patients tend to get about 3 cycles of chemo when its needed, so 50,000 x 3 doses. C-GSF, a 30 year old drug makes 6,500 a dose, 19500 a patient. In total about 1 billion a year. Conservative estimate, lets say the brand new drug plinabulin gets 6,500 per dose, 1 billion a year on this extremely conservative patient population. Taking another conservative estimate, 30% of those 50,000 patients will receive it, personally I think it will be standard of care to combine it with every dose of G-CSF but lets be conservative, it puts revenue at 300 million a year, for a company valued at 400 million. 3X peak sales for company valuation (again conservative, biopharm sometimes uses 4-5x peak sales) places an estimated valuation at 900 million, so more than double the current value. Now letting out imagination run wild, we open it to the Chinese population as well and open it to every patient who recieved G-CSF we receive a yearly revenue in the billions for the CIN use, with a company valuation over 10 billion. This is only for the CIN use, there is a non zero chance that the chemo use of the drug is approved as well following good results later this year, that would instantly skyrocket the company a few tens of billion in valuation. It is essentially a free lottery ticket included with the CIN use.

dickdaddyjrexttreme

Ill repost a short conservative market summary I replied to InB4uR >Lets just take the most conservative approval in terms of the patient population that is allowed to be treated by plinabulin and run some rough price estimates. Lets say is is only approved to be combined with C-GSF in breast cancer patients and no other and remove China from the population since the company only owns 51% of the rights in China. There are roughly 290,000 cases of breast cancer a year with 50,000 requiring chemo, that will be our target population. Patients tend to get about 3 cycles of chemo when its needed, so 50,000 x 3 doses. C-GSF, a 30 year old drug makes 6,500 a dose, 19500 a patient. In total about 1 billion a year. Conservative estimate, lets say the brand new drug plinabulin gets 6,500 per dose, 1 billion a year on this extremely conservative patient population. Taking another conservative estimate, 30% of those 50,000 patients will receive it, personally I think it will be standard of care to combine it with every dose of G-CSF but lets be conservative, it puts revenue at 300 million a year, for a company valued at 400 million. 3X peak sales for company valuation (again conservative, biopharm sometimes uses 4-5x peak sales) places an estimated valuation at 900 million, so more than double the current value. Now letting out imagination run wild, we open it to the Chinese population as well and open it to every patient who recieved G-CSF we receive a yearly revenue in the billions for the CIN use, with a company valuation over 10 billion. This is only for the CIN use, there is a non zero chance that the chemo use of the drug is approved as well following good results later this year, that would instantly skyrocket the company a few tens of billion in valuation. It is essentially a free lottery ticket included with the CIN use.

dickdaddyjrexttreme

Lets just take the most conservative approval in terms of the patient population that is allowed to be treated by plinabulin and run some rough price estimates. Lets say is is only approved to be combined with C-GSF in breast cancer patients and no other and remove China from the population since the company only owns 51% of the rights in China. There are roughly 290,000 cases of breast cancer a year with 50,000 requiring chemo, that will be our target population. Patients tend to get about 3 cycles of chemo when its needed, so 50,000 x 3 doses. C-GSF, a 30 year old drug makes 6,500 a dose, 19500 a patient. In total about 1 billion a year. Conservative estimate, lets say the brand new drug plinabulin gets 6,500 per dose, 1 billion a year on this extremely conservative patient population. Taking another conservative estimate, 30% of those 50,000 patients will receive it, personally I think it will be standard of care to combine it with every dose of G-CSF but lets be conservative, it puts revenue at 300 million a year, for a company valued at 400 million. 3X peak sales for company valuation (again conservative, biopharm sometimes uses 4-5x peak sales) places an estimated valuation at 900 million, so more than double the current value. Now letting out imagination run wild, we open it to the Chinese population as well and open it to every patient who recieved G-CSF we receive a yearly revenue in the billions for the CIN use, with a company valuation over 10 billion. This is only for the CIN use, there is a non zero chance that the chemo use of the drug is approved as well following good results later this year, that would instantly skyrocket the company a few tens of billion in valuation. It is essentially a free lottery ticket included with the CIN use.

RichSteps

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TomTom_ZH

Can you please just write out the ticker somewhere obvious? CSF is an ETF on nasdaq, do you mean another exchange?

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DrXaos

The original plan for GM-CSF antagonists is to reduce the severe side effects in some new cancer immunotherapies. There are some amazing CAR-T therapies coming to market but they have some significant acute inflammatory dangers, and a GM-CSF inhibitor appears to reduce that substantially. That's the longer term future for the drug. Obviously Covid revenue now would speed commercialization for cancer substantially.

__nerman

The drug is 100% dependent upon top line results coming out within 5 days. The recent studies out of the UK (among others) showing the role of GM-CSF in severe covid-19 patients reinforces the science behind Lenzilumab targeting GM-CSF. Current mRNA vaccines are helping tremendously BUT there is a significant portion of the population who refuse to take them, it's a big world (look at Brazil) and there are variants that we don't yet fully understand how the vaccines will handle them. There will be at minimum a multi-year demand for this drug if effective. That doesn't include DOD stockpiling. That's plenty of time for the Car-T trials, and others, the company is running to complete. Other drugs available to help suppress the cytokine storm are mostly ineffective. Ask the doctors watching patients die every day. Remdesivir, Dexamethosone, Tocilizumab offer help to some patients but not the most sick. The other approved MAB's are not approved for hospitalized patients that are hypoxic. There is a void in SOC that Lenzilumab can fill. The drug was selected by the NIH to be part of the ACTIV 5/BET trial that continues to add sites to the study. They chose Lenz out of 100's of drugs to compare to Remdesivir. These studies shut down quickly if they are not showing positive results. You can verify this looking at the other ACTIV trials. The data from the trial is being shared directly with the DOD even though the company has not seen them. The DOD, through BARDA, has assigned fill/finish capacity to Humanigen. That is one of their greatest resources. They can throw money at anything but actual resources are limited. Through CRADA (Cooperative Research And Development Agreement) they had Janet Woodcock working on behalf of the company with the FDA to make sure all their ducks are in a row. They are currently meeting with OWS on a weekly basis on CMC's (Control, Manufacturing and Controls). Every bread crumb you follow with this company highlights the favorable position they are in should anticipated results reach statistical significance. PT is more in the $5 - $50 range on initial results. With EUA it will go beyond that. $2 is too low due to the rest of their trials with KITE Gillead on Car-T and brain tumors.

IDLH_

Ah I see. This must scale with age too. In my mind, while were young we should just follow our instincts. As we get older, say maybe into our 30's we gain insight and control over this complex cascade of sexual energy. I think there is something to purposeful suffering, in this case abstinence even if just once in a while you say (I'll pass) even though you really want to get off. There's something on the other side, while you're on that edge. I'm so interested that SO many cult like followings get down to this same concept. Here's Jim Carey after spending some time on the other side talking like an insane person. He's joking right? https://youtu.be/MsQoofHvgDM?t=54 One time Will Smith was interviewed as he prepped for that boxing role in Ali. The reported says, "blah blah Will, what's the secret to transforming your body this way" (paraphrasing), and he responds, "No sex." I mean it's SO dumb but it sticks with me. There's obviously entire mystic traditions surrounding this thing too (kundalini, CSF cycle [Christ Oil / honey and milk]), etc. There's the confounding factor of porn stimulation vs. real human contact too. I don't know anything really, but I've enjoyed the path of seeing these things as "tools" and using them "on purpose".

DeepFuckingSquoze

Nahhhh.... can’t remember it... my crusty old boomer brain has all dried up. Need my monthly injection of unborn fetus CSF into my skull.

Came_to_name_a_puppy

$HGEN Not only are they on the Cusp of an EUA in Covid treating ARDS which could produce $1 Billion in 2021, but much more importantly: "The company is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Additionally, Humanigen and Kite, a Gilead Company, are evaluating lenzilumab in combination with Yescarta® (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration." https://www.businesswire.com/news/home/20201106005073/en/Humanigen-Announces-Cooperative-Research-and-Development-Agreement-with-the-Department-of-Defense-to-Develop-Lenzilumab-for-COVID-19 These breakthroughs would reduce side effects and costs associated with HSCT & Car-T which are slated for massive growth over the next 5-10 years. By greatly improving efficacy both treatments would advance much quicker, and at a lower overall cost making them more affordable/available to both Patients and Insurers. They are debt free with a highly experienced Management Team and well connected. Exclusive Licenses and Patents are in place. Worthy of the time required to do Due Diligence. It's just starting to run and with Phase III Data due in March for Covid and Car-T Phase 1 & Phase II data coming in 2021 the time to move is now.