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Ockham razor principle - Cytodyn has just failed the trial. If it's not absolutely and simply obvious from the PR (it is I believe but this is only my experience having worked 20 years in financial markets and 10 years hunting for stock frauds like Cytodyn) the stock insiders friends & family over the last 4 weeks (-40%) as well as the stock market over next week (expect -20 to -50%) will make it clear.
The PR gives enough statistical data to realize this is pure data mining. I did the computation today, whatever the ratios chosen for the various missing elements, under all possible scenarios, the trial failed and failed by a LOT. And these were the best, or least worst, facts Nader could come up with in the PR...handpicked post-hoc endpoints that were NOT part of the study design. Not acceptable for a phase III whose goal is not to refine a medical theory or to explore what could happen but to finally confirm a treatment works before unleashing it on million of patients. These datamined numbers are bad...as predicted Leronlimab acts no differently than saline, very expensive saline, and the stock price action will follow the CD10 course. History is just repeating, this was the same last August.
Excepted now the company is fully loaded with toxic loans, its toxic lender is fully loaded with convertible debt that can be dumped at a low price on the market, private investors are fully loaded with warrants they could (and should) dump above $3, and the ex-chairman of the board has million shares yet to be sold, he has just started. That's many, many actors who did not have these incentives to sell last August. Meanwhile the company has no cash to finance its unsustainable cash burn.
Monday and Tuesday will be a bloodbath.
Just waking up to that great failure.
Bravo Cytodyn, didn’t disappoint me. The same company that breaks every promise and misses every trial.
0 out of 5 endpoints met. Exactly what I had predicted, and many more skilled shortsellers had predicted before me. I drew my insights from >100 worldwide research studies that were all consistently showing that this trial was facing an uphill battle that was unwinnable, like the failed CD10 trial before.
As for the critical subpopulation, this is a textbook example of datamining for any student in statistics: they datamined a coincidence that is the result of chance. Let me explain: 63 patients is a tiny set and as such a 25% deviation of their mortality rate on one side or the other is EXTREMELY likely to occur just through random chance alone. For these 63 patients, whatever the placebo mortality baseline we assume (20 to 66% if you wish) and whatever the split between arms (20/80 to 50/50) I end up with p-values that dont support anything else than random chance everytime. Not statistically significant by far.
There is zero chance the regulators approve Leronlimab based on these Lotto numbers. At best, they will authorize Cytodyn to burn cash in yet another trial or extension that will take a year to complete. It took 9 months to get these 63 patients, it will take at least as much to add 100 or 150 assuming current hospitalization and mortality rates are stable in the US. But they are not: they are crashing down due to mass vaccine campaigns everywhere in the US so Cytodyn missed its « window of opportunity ». Worst case, regulators ignore Cytodyn’s demands like they did for CD10. Remember the 50 patients interim that got ignored (zero communication). Remember the patients resizing analysis requested by the DSMC that got ignored by management. It was all a show.
This proves everything I have written on the statistical side.
Now on the business side I have also written that I believe this company is a stock market fraud whose real objective is self-enrichment of its insiders. Everything they have been doing over the last years, and in CD12 in particular. Dumping shares before trial completion. Overcommunicating even small successes while hiding important pieces of bad news from their shareholders. This will continue next week as Nader is pivoting into Long Haulers. It’s a fraud engine that will never get anything approved anywhere. Reread this PR with this framework in mind. Nader is anything but certainly not transparent, the 3-4 key metrics are missing from this PR. It’s on purpose, to prevent non-statisticians (that dont know how to workaround these gaps) from running the numbers.
Every OTC company has PR/IR firms indeed.
But >15 communication/PR/IR/promotion firms declared only in 1 year, that's something.
Just scroll through the disclosures on OTC Markets website for other companies. Cytodyn is way ahead. And we are speaking about OTC companies, the land of the pump & dump, which precisely tend to have a LOT of communication compared to their tiny operations.
The difference lies in the numbers and the intensity. More Proactive videos than updates on the clinicaltrials official website. More "outstanding" and "promising" PRs than most biotech firms out there. This company operates as a Cult: promotion and insiders self enrichment are THE major corporate activity.
Just in the previous disclosures! That's how they started the Leronlimab COVID fairy tale in 2020.
I listed more than 18 firms declared in 2020. These are facts from their own disclosures.
If Dr. Rahman had all these qualities with such superhuman capability to only research winning drugs, he would not have left MESO 2 months before its trial was publicly revealed as failing to meet its primary endpoint, and the story there would have been successful instead.
He is just a human not a superhuman: making mistakes, misjudging situations, jumping to another ship when given the opportunity, not refusing a good package.
Certainly not an investment thesis by himself.
Yep Cytodyn like every fraud is very careful about declaring the absolute minimum required legally, and nothing more. In that case they had to disclose it to OTC Markets:
https://www.otcmarkets.com/stock/CYDY/disclosure
Unfortunately we will have to wait until next August's OTC disclosure to know the service providers who are pumping the stock today (2021). But we already know there must be Proactive (they did a couple videos so they are still working together obviously) as well as several of the old timers.
When a company has only a couple employee, promotion with so many providers is a red flag. This explains a LOT of the to-da-moon posts seen on various media - I believe these were not honest articles or posts by true fans but manufactured articles to create enthusiasm. I suspect some of these providers are operating illegally, by not revealing that they are being paid to promote the stock. Once the SEC investigation goes public, this fact (whether it is true or wrong) will be revealed.
In all stock market frauds I tracked over the last 10 years this reveal always came as a big surprise. It's large scale manipulation, as old as Wall St.
A sample of service providers declared in 2020 by Cytodyn:
Alliance Advisors
Lippers/Heilshorn & Associates
Equisolve
BioScribe
NetworkNewsWire
Robert Schatz
Michael Sheikh
Investor Awareness
Content Carnivores
Red Chip Companies
Proactive Investors
Global Discovery Group
Resources Unlimited
LifeSci Public Relations
Edison Investment Research
Marek Ciszewski
Michael Elliot dba CEO Live
MoneyTV
Wall Street Reporter, Octagon Media Corporation
Shift Media Lab
Results Media
Stir-Communications
That's way more than 12. A tiny company that declared more brand awareness/promotion/IR/marketing/consulting/stock promotion firms than employees! It's one of the signs that Cytodyn shares with all the stock market frauds I have successfully shorted in the past. And far from the only sign. That's one of the reasons, and far from the only one, I keep hammering here that Cytodyn is a promotion business, not a biotech business. Its real purpose is to pump its stock, and dump shares for the benefit of its insiders (through salaries, stock grants and warrants).
It's the only explanation consistent with the low quality of their research, their constant delays and the staggering amount of "great results" announced by management that went absolutely nowhere afterward.
Yep - a textbook example of a fraud stock.
A cult leader, CEO Nader Pourhassan.
A promised land that never comes, Leronlimab.
Everlasting choirs, the >10 stock promotion firms paid by Cytodyn.
It's a machine designed to steal money, and a nice one.
Stock down for the fourth week, fourth -10% fall.
I sense fear.
This emotion happens to be rational because Cytodyn is a fraud and Leronlimab acts like a placebo.
It will only fall down more and more to less than $0.5 as the financial hurdles and statistical deficiencies compound.
I havent taken the time to answer the statistical and medical long thesis. I obviously think it is wrong for several factual reasons that anybody can check based on SEC filings. I may answer it.
Stock going down to the seventh circle of hell. My proverbial kids and I are very happy to be short this stock fraud.
I AM DIP BUYING !!! AH AH AH AH
Wrong. The p-value threshold is not the probability that your result is not valid. This is something learned in first year of Statistics course for any student in mathematics (I am a statistician so...I know). In these courses it's exactly presented by the professors as the fundamental fallacy in statistics.
That's the reason blind studies analyzed by real statisticians are critical to neutralize biases as much as possible, and the reason eIND studies are just storytelling by cult doctors and their patients. At some points the medical "science" has to be confirmed or rejected by unquestionable hard statistics. That's another "science", different skills, different rigor, and it often rejects the medical theories. Like it already did for the first Leronlimab COVID trial (a failure, the Leronlimab MOA didn't work as expected!).
This entire company and its drug are just a stock market fraud, as I have pored through every paper they have published, every statistic presented there and the number and depth of their defects are astounding. But that's another discussion.
My post above was exactly this evidence, right from the company itself - all of that disclosed in their SEC filings available for free from the SEC EDGAR portal. The company did not make it easy as they always delay and present negative information in a convoluted way, often on the very last line of unrelated documents. That's for the first COVID trial, the one that was supposed to be a "sure bet". Well, the sure bet has failed.
As for the second (pending) COVID trial, I posted many other analysis of comparable research papers on this board and on Twitter, compiling information from more than 100 research papers from the very best research teams. These paper show that in Asia, in Europe and most importantly in the US (I focused my analysis also on US-centric papers to make sure that I would be as close as possible to Cytodyn's trial conditions), that Cytodyn's mortality rate seems not different from Standard of Care mortality rates for a mix of Severe and Critical patients. Based on these statistics, Leronlimab is behaving no differently than the old standard of care.
A last fact: Nader is hiding, again, under his desk. He has been dreaming for more than a decade to get public recognition. Yet, with the results on his desk, he is still hiding under his desk. Back to statistics, we know that everytime Nader has been silent and delaying information, the result was revealed to be bad or aborted 6 months after, or delayed by 12 months. This was the case for several HIV trials. For the Remdesivir + Leronlimab trial (who remembers it? I didn't initially). For Thailand. Mexico. The MHRA. For the 50 patients CD12 interim (who remembers it? I didn't initially) which got conveniently forgotten. For the NASDAQ application. For the Philippines. For the HIV BLA application. It's a pattern. It's the Constant Nader Failure model.
Failed primary endpoint, 17/18 secondary endpoints failed, last secondary endpoint datamined with a post-hoc change of its definition, no regulators interests in any country, detailed data never published by the company. These 5 points are the very definition of a complete failure.
5 out of 5. Impossible to do worst than that.
Saline within a fraud company would have gotten the same results.
We had a good laugh this afternoon again with my proverbial kids.
Going through Cytodyn's studies' gaps - always funny to realize the most important metric, measurement or statistic is missing or has been concealed on the side of a complex chart or table without any comment in the text sections.
Watching the promotion firms paid by the company (read the SEC filings, 12 such companies are listed there) trying to advertise on Proactive or elsewhere every bad news as a "secret" good news. This inverted thinking really made us laugh.
While the stock has been fading of course today, filling its quota to lose another 10% this week, like each of the 3 previous weeks.
A perfect example of compound losses, if we had used this fake opportunity to "buy the dip". Fortunately we didn't. We know the difference between a stock market fraud and a real deep value opportunity.
Saline does not have data proving that treated patients got worse after they were treated. Yet Saline does not beat standard of care and never got approved as a treatment against COVID.
Simple logic. Really.
To be approved a treatment must prove that it performs better than standard of care, not that it doesn't perform worse.
Obvious logic. Really.
As much as Cytodyn is up 10 cents today. AH AH AH SUCH A FRAUD STOCK
I teach my kid not only compound interest but also compound losses. Works the same but in the other direction. I feel this is equally important regarding Cytodyn stock and their future financial life. We have good laughs considering all the gross lies the CEO has gone through and how he manages to pump the stock yet never deliver anything. It's an important lesson.
CYDY is most probably going below $0.3 below the end of year. It's a fraud and it has played most of its tricks. The Merry Go Round fraud of the CEO Nader Pourhassan can only play for so long.
Cytodyn is a stock market fraud
It's only objective is to enrich its insiders through false hopes, paid promotion firms, delayed and convoluted communication of its trial results.
As I have shown many times through >100 research papers, it's entirely normal that Leronlimab failed for the CD10 mild/moderate COVID trial, and will fail again for the pending CD12 severe/critical COVID trial.
The HIV published studies are all fishy, curious gaps in the communicated results, uncomplete statistics. Same for the COVID eIND studies, they magically never disclosed obvious figures. Same for the cancer mice studies. It's an illusion designed to be "sold".
It's the Titanic, but run by a fraudster. Great "dip" prices on 1st class cabins. Excepted it's going down down and down and the captain has already left on his luxury lifeboat (and has no room for you).
CD10 is a failure based on the press releases from Cytodyn itself, its shareholder’s committee pack as well as the lack of interest of all country regulators, in the entire world, for each and every week and month since last July. Quite some time has passed. Yet here we are. I could also copy&paste the last line from Cytodyn’s Christmas PR. This company is a cult. Like every cult it promotes fake promises, and takes money away for the benefit of its leaders.
Bruce Patterson had Cytodyn shares. So he was incentivized by Cytodyn. He has tried to hide it, claiming that he has not aware (!!!), until this got proven through Cytodyn SEC filings. You were not aware of that?
As for the FDA, they are precisely the only ones, along with regulators from other countries, to block Cytodyn. Because they have no financial incentive to let them go through if Leronlimab is a failure (which it is based on what got disclosed).
I heard exactly the same during the first week. Then the second. Then the third. Problem is the weeks counter is going to infinity...Cytodyn is just going down, like the Titanic, because the company is a medical failure, a stock market fraud, and soon a financial bankruptcy. Great deals for 1st class cabins all along the way but the ship never goes up anymore.
Wrong - this was tracked by the CD10 COVID Leronlimab trial completed last summer which failed on all these endpoints. Primary endpoint failed. 17 out of 18 secondary endpoints failed including mortality, need for ventilation, SpO2, etc...
Basically Leronlimab could not prevent these « soon to be severe » patients from switching to ... severe.
The company datamined only 1 endpoint which, due to the datamining, got a NO from the FDA as well as all foreign regulators. A failure.
Leronlimab could not prevent anything bad from happening. Last Xmas the company recognized, hidden in the very last line of an unrelated press release that CD10 results were not good enough to request anything from regulators. And the FDA reoved the eINDs for these patients. That’s pretty clear...
Exactly plus the critical statistical defects of everything that has been published by Cytodyn:
- The HIV studies which all have strong methodological defects + bad stats once these are looked for (no wonder why the HIV BLA has been delayed for years)
- The Leronlimab eIND studies the same (no wonder Cytodyn is delaying now that serious studies, CD10 and CD12, could reveal the truth)
- The cancer sideshow the same
Note these studies are all done by people who have a financial link with Cytodyn. This is what I call sell-side research. Like sell-side research on Wall Street, same rosy glasses and same important factual questions magically sidestepped in the papers. No wonder why smart, educated people avoid answering the key questions in their paper: of course they know perfectly about these questions, they just don't want to answer these! Why killing the golden goose when it gives you golden eggs.
I am happy waiting for the long haulers study which will demonstrate the same qualities.
I am sure an incredible Cytodyn share opportunity at $4.0 will be offered. As well as $3.5. Also $3. Then $2.5. $2 along the way. Sliding to $1.5. Fading to $1. Then $0.5.
So i am not sure how to « time » the « dip ».
This job posting is the ugly truth about Cytodyn.
They are getting ready to dump a LOT of shares on the tiny OTC market.
Doesn't speak confidence about the pending CD12 trial. Does it.
If I had bought the stock I would be really worried. Happy I took the correct side.
If I had « bought the dip » during the recent fall from $7.5 to $4.5 I would be crazy worried.
CYDY has gone down 3 weeks in a row. We know how this 4th week will go...
Nope
CD10 is a failure - after 6 months no regulator worldwide, in any country has been interested. It’s the most direct proof and nothing can change this ground truth.
I have never assumed CD12 excluded critical patients. To the contrary my point was that including them could not save the trial from failure whatever the mix ratio with severe patients.
It’s over and the stock price slide is just starting to reflect this ugly reality. Reality.
The stock has gone down for 3 weeks in a row, during a time frame where it was supposed to explode upward due to the anticipation and insiders friends & family buying based on tips.
That shows there is an issue. A deep issue. Like every promise and trial done by Cytodyn before, this one is going nowhere. Leronlimab has failed, again. Again. And again... Explains perfectly Nader's behavior, his CFO programming a sale of his shares after the interim, etc... it's over and today the sale price is a time-limited offer to exit the Titanic without too much pain.
I have shown many times here the statistical reasons (across >100 worldwide research studies) explaining why Leronlimab is a statistical failure, and the business signs that Cytodyn is a stock market fraud whose real purpose is to steal cash from its investors to enrich its insiders. Everything is consistent and aligned.
Wait the stock has gone down for 3 weeks in a row, during a time frame where it was supposed to explode upward due to the anticipation and insiders friends & family buying based on tips.
That shows there is an issue. A deep issue. Like every promise and trial done by Cytodyn before, this one is going nowhere. Leronlimab has failed, again. Again. And again... Explains perfectly Nader's behavior, his CFO programming a sale of his shares after the interim, etc... it's over and the sooner the mourning occurs the better the sale price to exit this Titanic.
I have shown many times here the statistical reasons (across >100 worldwide research studies) explaining why Leronlimab is a statistical failure, and the business signs that Cytodyn is a stock market fraud whose real purpose is to steal cash from its investors to enrich its insiders. Everything is consistent and aligned.
Compare instead the press releases and the shareholders statement to the clinical trial definition. Compare carefully. There is a huge difference.
Advertised results have been handpicked and do not follow the trial specifications
It is not logical for a country regulator to not approve an available treatment in the middle of a pandemic because it also has severe/critical patients. That simple fact alone proves CD10 and Leronlimab were failures. Zero country went for Leronlimab or Cytodyn. Zero. Zero. Zero. Etc...
When a country has no treatment available (and the next trial won't deliver results for at least 6 more months, remember CD10 was completed last summer) it doesn't need to "focus" anywhere. It just validates whatever comes through with statistically significant results. This in turn could provide more treatment opportunities to physicians, including borderline moderate/severe patiens. Zero country did that with Leronlimab after CD10. Let's face it, CD10 was a complete failure, worldwide.
Endpoint modified ex-post, which means it was a failure. And the 17 other secondary endpoints were failures. As well as the primary endpoint. Then, zero regulators, across all countries in the world, were interested in approving Leronlimab for mild/moderate patients based on that study. It's pretty obvious: CD10 was a huge failure
You do realize the endpoint formula here has been changed ex-post - this is a classical example of datamining. It proves the company had really nothing robust to show...and instead tried to trick its shareholders by changing the definition to overfit the noise in its data
It states this only for legal reasons. Legal disclaimers are present in every "pro" blog or website. Even on Seeking Alpha. Nothing strange there. The opposite would be surprising.
Buyer's Strike is an outstanding old-timer analyst. His posts about Cytodyn list only facts, from a variety of sources that make me jealous (often I discover a new public database thanks to his posts). It's a great source to decipher through the eyes of an expert what the company is trying to hide/tell.
A proof that it is Cytodyn, not the FDA, that is slowing down things:
https://buyersstrike.com/2021/02/26/while-we-wait-5-what-other-study-results-are-cytodyn-hiding-cydy/
The FDA has zero responsibility in that failure. It all comes down to the company who has generated over-the-moon expectations that it can't meet. Through >12 promotion firms that it pays, exagerations in each and every conf call, and dissimulation of bad outcomes from past Leronlimab trials. The company knows it can't meet the expectations.
The FDA is just counting the points, it is not responsible for a failed drug.
Every regulator from every other country will just reach the same conclusion.
They are not evil, they are just the first transparent organizations ever to deal with the data. The messengers that get shoot in that public eyes-opening process.