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Or Cytodyn will abandon a few thousand investors with 100% capital losses. Like the hundred pump & dump stock frauds who generated exactly the same expectations
Many short-seller funds crawling around CYDY today and announcing it publicly...sharks are gathering for the feast
With an "outstanding" toxic refinancing, because, well, by my calculations >$15 millions are already missing
Nope. Based on all its promotion patterns, It's just a pump & dump fraud like hundreds of fraudulent stocks before. Same patterrns. Same "sure thing" deadlines. Same promoters. Same failure to come.
Great thread on Cytodyn:
Let's talk $CYDY. As an M.D. and a human, I _hope_ their imminent phase 2B/3 trial result for severe covid-19 is a success. However, as an investor, I'm short the stock, because it's trading like it's 1999, with a $4 bil mkt cap, even though its only clinical asset is from 1999.
— Midwestern Hedgie 🏳️⚧️ (@MidwestHedgie) February 12, 2021
Nope if this were true that would be a gold strategy for hundreds of hedge funds out there...buy share of biotechs before approval where the FDA did the same...and sell upon approval. If this were true these hedge funds would have already raised CYDY stock price to $20+. This is not the case so...this does not work.
Nope. For 3 reasons:
(1) Placebo mortality shall not be 27% but 15-25% - because, as written in my post, milder cases have to be mixed in, whether we call them "severe" or "low-risk-severes", and whatever the realistic mix ratio you choose
(2) Deaths are at least 87. Because there were 9 days left in the study when Nader Pourhassan the CEO revealed the 87 deaths. I estimated based on the disclosed December numbers and mortality curves published in various research papers that these days shall have added roughly 3 deaths to the count (plus or minus something). So a total of 90 deaths on average
(3) These are already bad statistics. But what makes it work is statistical power (i.e. probability under these mortality rates that a statistically significant effect is detected): if you compute the power properly you will see...the trial is heading for failure.
The Tocilizumab study SHOWS that Cytodyn's trial will end up with a <25% mortality for its placebo arm, making it a failure.
There are 3 reasons for that:
(1) The Tocilizumab study's placebo arm had a mortality rate of 33% (694/2094)
(2) BUT the Toci study selected only patients with a C-Reactive Protein (CRP) above 75mg/L.
Which are patients with a much higher mortality risk. From this paper, figure 2, panels A and B, simple algebra (remove the first quartile and half of the second quartile) shows us this criterion raised ICU mortality by more than 3% in the Toci study.
(3) WHILE we know Cytodyn's excludes among the criticals the high-risk patients (study specifications, see the inclusion criteria number 3). We estimated based on previous papers, including a large study performed across 65 US hospitals that it reduces the Cytodyn's mortality in ICUs by roughly 3%.
So, the Toci study eliminated low-risk patients, and the Cytodyn study eliminated high-risk patients (plus has milder cases, the "severes").
And we can estimate the Cytodyn mortality for criticals:
around 27% (33% - 3% - 3%).
Mix these with the severes (8-12% mortality) with whatever mix ratios you prefer, and statistical significance is out of reach: Leronlimab acts like saline.
Just like July 20th. Similar trial (COVID CD10). Same expectations. Same price gap in the early afternoon, with same volume. PR out right after close. A failure despite PR spin. Stock fell after for weeks.
Same speculation.
Nope. The trick is not in the "exclusion criteria" of Cytodyn' CD12 study that you have listed, but in the "inclusion" criteria. In reality some of them act like exclusion criteria. Criteria number 3 in particular is VERY strict. It excludes among critical patients the ones with a high respiratory distress. The question becomes then: if it excludes "high distress" criticals, how many are excluded? As I demonstrated based on the number of ar recent COVID study across the entire US (hundreds of med. centers), roughly 40% of the criticals are excludeed. These are the "diers" (sorry for a lack of better word), the ones carrying all the mortality. The tocilizumab study (and >95% of the critical studies I found) do not exclude them.
Nope. Cytodyn does exclude the high-risk criticals from itss COVID study. Inclusion criteria number 3. Most competing studies do not exclude these. And I haven't talked yet about Severes which have a very low mortality rate, so low the only alternative consistent with Cytodyn's 22% combined mortality is that Leronlimab acts like saline. It's game over for Cytodyn.
Nope. Criticals and Severe+Criticals are not the same thing. At all. It' game over for Cytodyn.
Also, the belief that this company may redistribute some value to its shareholders is, I think, erroneous
I wrote yesterday that I think they will steal all the value from shareholders and I maintain that.
All meant all.
I believe the value that will be left in the bankruptcy and/or dilution process for the old common shares will be $0 a share. Like most pump & dump scams. Doesn't mean the company won't survive, but through mass bankruptcy shares cancellation or mass dilution, the old shareholders (not the new ones) will have nothing left.
Why do I think that? Because Cytodyn matches more than 20 patterns that are, in my experience, predictors of a stock market fraud. I have shorted more than 100 frauds over the last decade...and Cytodyn matches all their patterns.
To apply that, I combine different approaches. Thankfully I am not limited by a job in financial markets during the seventies (yes I was already alive back then). Also worked there in the 2000s, a much different time. Computers. Realtime market making everywhere. Stock promotion of scams through the internet. Most importantly, aside from financial markets, I did quite a lot of management consulting. Very useful to learn how top company executives behave. It's critical to be capable of not seeing the stock only as a FINRA/SEC/... transaction detail, but seeing it as a piece of a real business with real stakeholders, executives, investors, patients, customers, etc... in the real world. The big picture is key for an investor, not the mundane details.
The trap with all scams (like Cytodyn in my opinion) is that investors' unrealized P&L is bright green until the scam implodes. There, it becomes bloody red.
Enron, Madoff, Theranos, and countless others.
We are in the bright green stage (for those that bought below $5.5, because those who bought at $5.5-10 are already in a bad seat).
Thanks for the opportunity to make this point.
Yep, mock data is very useful, and not only in the biotech industry. In every place where we prepare data exchanges.
BUT what is unique here is that this level of detail is never written usually in press releases. Because these are obvious and, frankly, as important as they are, still execution details. Cytodyn is the only firm I found who included this level of detail in a press release.
That makes it a strange anomaly.
If the CEO, Nader Pourhassan, has chosen to write them here, it is for a reason. He is smart and only writes 2 kind of sentences in his PRs:
- "Great news" sentences
- Negative sentences, because he is forced to. Why is he forced? Due to SEC regulation: CEOs have to be very careful and prove at every step they they duly informed their investors about potentially negative (compared to past press releases) developments
The later sentences are usually hidden in the middle or bottom of press releases. This one fits perfectly. He wrote it because, in my experience, he was forced to disclose the issue (that their past submission to the FDA was not a complete submission but only a preparatory one with mock data). The last thing he wants is a class action lawsuit from his shareholders. And he knows he may get one some day. So he is strenghtening everything, making sure every negative news is communicated later if not earlier.
In that case, my explanation is the following:
- He announced a submission to the FDA that, in reality, was a mock submission, missing real data
- He later did a PR to reveal the submission had mock data
Only Cytodyn does this kind of thing, it's outrageous to shareholders. Shareholders are the owner of this company and should get first class transparency, not "mock" PRs.
Of course, this is public knowledge, I am short Cytodyn. And long and short many other stocks, way beyond Cytodyn in fact. Cytodyn is a tiny part of my portfolio (as surprising as it may sound): 1% (I belong to the 1% club). The reason I focus intensely on Cytodyn is that, to sharpen my skills, I obsess every 4 quarters on a different stock in my portfolio, trying to get to the bottom of it. Currently this is Cytodyn. This is a great trick to both learn a lot (superficial analysis doesn't help to sharpen skills) while at the same time managing squeeze risk (for shorts) appropriately. Never go above 1% when you are short (or above 10% when you are long). These have been two of my principles and it works well. Another principle is to force yourself to read contradictory analysis. I read a lot of longs articles, posts, everything. If you are long, read Buyer's Strike posts about Cytodyn and everything the shorts post on Twitter. I know this is hated by many but this is how you strengthen your analysis.
So, frankly, what happens to Cytodyn is not my worry. I trust my analysis and I know 1% won't affect my portfolio a lot whether my analysis is correct or is wrong. And I would recommend any investor that is not in that case to seriously assess whether it's a calculated large bet (a la Charlie Munger / Warren Buffett, but they did only a dozen of these over 60 years, so one every 5 years roughly) or a gambling addiction. Often the later is hidden behind the former.
Have a nice day.
That was a typical retail investor trade that created this spike in CYDY stock. Why? Because he apparently sent a large order in a single shot. He was not aware of what market liquidity (tiny on OTC) means and the need to break down large orders into manageable icebergs...as a consequence he lost quite a lot on his execution. Red right out of the gate.
If that’s the kind of traders operating during CYDY power hour today, short sellers and market makers will be bright green!
Yes, Cytodyn has sent mock datasets to the FDA...
Happy to provide assistance and details:
just read the company's own PR
and search for "mock":
The clinical datasets are updated to address FDA comments for mock datasets from March 12 and March 20, 2020.
This was exactly my point: Cytodyn loves to pump up intermediary steps but magically gets nothing through the finish line - how many biotechs write a press release for having scheduled a conference call with the FDA? How many biotechs send simulated data to the FDA instead of real data? How many biotechs decompose the HIV BLA submission in 3 steps, several months (years?) after the trial has been completed? How many biotechs of 20 employees send 5-15 PRs a month while getting nothing approved after several years? We will soon know through press releases how many cars are on the corporate parking lot.
Like all frauds, to realize the trick the astute investor needs to stop looking at the illusionist's hands. The illusionist here is the CEO, Nader Pourhassan. The illusionist's hands move a lot to distract attention from what's really going on. Nader has been doing exactly that.
Meanwhile, he earned several millions USD for a product that, 9 months after he became rich, still has zero approval, anywhere. And countless promises have been piled up in between. Yet, ZERO approval.
Expectations have been set very high, and reality is very poor in comparison.
Excepted if the company is a fraud as I and many others are claiming. In such case, Cytodyn takes all its investors capital, distributes it amongst its insiders through payroll & warrants, and ciao, investors lost everything.
And what a coincidence, Cytodyn has already started doing this, judging by the huge packages of the CEO, and how he and the CFO sold >87% of their shares while they were pumping the stock and making great promises for things to come just a few weeks after.
Zero progress on the approval side (despite countless suggestions & promises). 100% progress on the insiders enrichment side. Obviously interests are not aligned between shareholders and insiders.
Well “fake statistical significance” means data mining by Cytodyn without proper corrections for multiple testing, as I have explained already and as every statistician knows. Sorry but that is my academic training, my specialty and has been my career for 25 years.
No, the Leronlimab CD12 DSMC had requested 2 changes:
- A new 75% interim to, I quote the CEO, reestimate the number of patients needed
- An extension of the mortality measurement from 28 days to 42 days
It’s Cyrodyn’s CEO who has refused their recommendation and kept the trial unchanged.
So it is looking a LOT like the RLFTF story....highly probable failure at 28 days and noise after 28 days that may be tentatively spinned as a good news by management...with the added difficulty for CYDY that Cytodyn’s CEO didnt follow the DSMC statisticians recommendations....so any post-28 days data is very probably partial, contaminated by unblinding and heterogenous across oatients and med. centers, putting them in a corner. They shall have gone for 42 days way back in October when it was possible to organize all that.
Yes and thats why that specific RLFTF analysis is doomed. No wonder their stock didnt go up today.
Too late for the 28 to 42 days mortality endpoint extension.
Because...the patients have been unblinded in mid-Jan. and/or disbanded at 28 days. Once it’s done, once everybody knows who had Leronlimab and who had Placebo or has been disbanded, it’s too late to acquire “clean” data. Cytodyn made this bad decision, killing any hope to build a solid case for 42 days mortality dataset for the FDA.
That was a clear mistake from CEO Nader Pourhassan. He should have accepted the DSMC recommendation to extend to 42 days back in October, before it was too late, before the unblinding. That would have been a tough decision, sure to meet challenge with the FDA, but the only sensible one. He did not and chose the lazy road instead. He is stuck with the 28 days data now.
Of course he can try to “sell” whatever post-28 days statistics they have collected and data mined. But that would be ex-post, partial, data from patients and med. teams who had been previously unblinded and/or disbanded. Contaminated and tainted 3 times. Impossible to build a case with that.
The problem with sub-groups is that you lose very quickly statistical power. What I mean by that: this was a relatively small trial (390+ patients is not huge). As you start to slice and dice the subpopulations you end up very quickly in tiny pockets with few patients, too small to prove any significant effect (against a statistical penalty that jumps up very quickly as you multiply the number of tests you want to perform). A trial with 2000+ patients allows this kind of thing. Here it’s an uphill battle right from the start.
And as I wrote several times already, i think the DSMC already faced a challenge with the number of patients for the primary endpoint, because they requested the new 75% interim review to, I quote Cytodyn’s CEO, perform a “sample size reestimation”. Which is what you do when you are not sure you have enough patients to reach statistical significance for an hypothetical effect. We are not talking subpopulations there, just the primary endpoint alone! The reason for this error is, I believe, because the trial was severely underpowered right from the start. Because it assumed back in April when it was designed a placebo mortality rate way above what it has really been afterward. I think the DSMC realized that misspecification issue during the 50% interim review and, instead of cutting the trial, asked for a trial size reestimation at a new 75% interim. Too bad it has been refused by the CEO. He will pay for that mistake.
You stated
As a statistician, you should appreciate that "pure random chance" and statistically significant are diametrically opposed.
I agree, not following the DSMC recommendation was a crazy and stupid move by Cytodyn’s management. Now, after the facts, picking a different endpoint will be next to impossible to explain to the FDA. Too easy to engineer fake statistical significance if they can handpick ex-post the data fields and sub-populations that happen through pure random chance to serve their storyline. It’s data mining and the FDA will be very cautious and strict there, too much human stakes on the line to let the company play these tricks.
Nope. The Relief trial specification explicitation requested ventilated patients. These are Criticals by definition for Cytodyn. Sorry.
The PR has been written (1) early on and (2) for the general public, where words like "severe" and "critical" are not as rigorous as what clinical specialists use.
The clinical trial specification has been (1) updated all along and (2) written by clinical specialist.It is directly comparable to Cytodyn's specification written according to the same scientific standards.
It's the same with tech company PRs versus what you read in the API documentation, etc... CEOs PR vs specialist documents.
The second ones are much more reliable. CEO PRs, well... serve a different purpose and/or don't follow the same standards.
Nope. Their detailed trial specifications on clinicaltrials dot com clearly states, both in the very title and in the specification details, that these are clinically critical patient. It has been kept up to date by Relief clinical experts, they know.
How is that immoral to short-sell a stock fraud like, all short-sellers believe, Cytodyn?
Nope. The RLFTF numbers are public. Cytodyn's combined mortality numbers are public.The 100+ research papers I have reviewed in the past are public. I am just showing yet another time that all this data indiicates that Cytodyn, if it is aligned with the rest of the world, shall have failed its trial.
RLFTF MORTALITY RATE ANALYSIS FOR PLACEBO ARM
From its recent disclosure, we know RLFTF placebo arm had 67 patients, out of which 20 died at 28 days. So a 29.8% mortality rate.
Reading the study description tells us these are ONLY critical-clients. And in fact, the high-risk ones regarding Cytodyn's criteria (some Cytodyn criticals would have been refused from the RLFTF study, too "mild").
So that confirms what I have demontrated through 3 reviews of the worldwide and US-centric COVID research litterature in the past: we shall expect a roughly 30% maximum mortality rate for Cytodyn's CRITICAL patients. Not more. In fact, Cytodyn shall even be lower given that it excludes patients with high respiratory distress (criteria [3] of its inclusion criteria list)
But the Cytodyn trial also has SEVERE patients. We know from litterature their mortality is usually somewhere around 8-12%.
Mix both with various ratios (e.g., 1/3rd to 2/3rd) and you realize that Cytodyn's placebo arm shall have a mortality between 15 and 24% MAXIMUM. Which confirms ONCE AGAIN all the estimates I did in the past from all the research litterature I could find on this topic. This is all consistent.
And this placebo mortality rate, as Cytodyn's investor know, would make its COVID trial a failure. Because with a combined mortality rate at 22%+ with a trial that has 2/3rd of patients treated with Leronlimab, that would mean Leronlimab acts like saline...a placebo...
PS: also RLFTF did the same "keep going with the study" interim thing as Cytodyn. Which proves, as I have been explaining in detail before, that having the DSMC and management asking to continue a study is NOT a proof that it will succeed. In Cytodyn's case, management even dismissed new requests from the DSMC to introduce a new interim to reevaluate the number of patients needed...this may explain why today the company is still silent, more than 3 week after its promised disclosure of the trial results
The exact same rationale could be used for Cytodyn long positions. Following this rationale, if long positions were correct (=if Cytodyn were such a great investment),, everybody would be long. Yet this is not the case. So we reach a contradiction. That shows the rationale doesn't work. The fact that there are both long investors and short-seller is symmetrical, both regarding their correctness (it doesn't prove any is more correct than the other) and morality (it doesn't make any of them more moral).
So, again, why is it immoral to short-sell Cytodyn when someone thinks it is a stock market fraud?
Excepted if Cytodyn is indeed a fraud. In such case everything there is accurate and shall not be discounted. There are many, many fraud signs and pattern that are matched. The probability that Cytodyn is a fraud is much, much higher (to me) than the probability of Leronlimab getting any approval.
Cytodyn looks just like Theranos and dozen other frauds.
So fighting against a perceived Cytodyn's fraud is immoral? Please expand
But Cytodyn short-sellers are stating that Cytodyn is a fraud, whose goal is to enrich its insiders at the expense of minority shareholders. How is it immoral to state that?
Nope. I was just writing that this statement is wrong:
"There's no way the FDA would have given OLE and eIND if the trial failed. "
"No way" is obviously wrong. Otherwise there would be tons of biotech traders and hedge funds who would lift any stock who gets OLE or eIND to its target drug FDA approval price immediately. This is not the case. So there are "ways" and the statement is wrong.
I implied nothing else.
None of that investigation helps Cytodyn in any way. A distraction at best. Because companies succeed or fail on their own. For example if Leronlimab is unable to cure COVID (my own conclusion based on past disclosed data and lack of transparency from the company on closed trials and interims) there is nothing that will save CYDY stock from oblivion. Now any stock promoter who has pumped this stock without disclosing a payment by the company will be investigated and convicted by the SEC, as it is illegal. They shall not believe they are protected by anonymity, everything is logged. But my point is that, even if that will make me happy to know that justice has been served, these are side shows - they won't change anything for the stock that will go to $0.25 once the failures combine with the bankruptcy to trigger a mass investors exodus.