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This reinforces my post, as the ICUs study I used was based on very early (elevated) mortality data: March to May. Your point means Cytodyn's expected placebo mortality should fall even further below the 17-25% I had computed, making things worse for Cytodyn.
Full analysis of the expected Cytodyn COVID placebo mortality rate below
Right from Twitter:
1/ As promised, here is why I believe Cytodyn's COVID CD12 trial will be a failure
2/ Obvious disclosure: I am European, English is not my primary lang. I don't work for any fin. inst. and have never worked for/with/against Cytodyn. So, I got no leaks sorry! Last, my posts are solely opinions protected under the 1st
3/ As some have posted, $CYDY needs around 35% mortality in its placebo arm to make it's CD12 trial hit statistical significance in the primary mortality endpoint. We know that because Cytodyn has disclosed its deaths across arms (>=87) on the Jan. 6th conf. call
4/ If the trial placebo arm has a mortality above 35%, it's a win for $CYDY . If it's below, a VERY probable fail. Some have been quick to point out that 35% happens to be the mortality in US ICUs, from there they imply (too quickly as we will prove) that it will be a win
5/ So we asked ourself the question: what are the mortality rates we could expect in the US for the typical $CYDY placebo patients? We had already an answer previously, between 12-25% based on 50+ global studies, both in and out of the US:
Twitter thread
6/ But some retail investors keep coming back to the ICU 35% mortality rate, arguing that they contain both a lot of Severes and a lot of Criticals and thus their mortality rate is representative of $CYDY trial
7/ I will prove below, based the MOST COMPREHENSIVE US ICUs study available to date, that it is wrong, they are much HIGHER RISK than $CYDY patients. And that, again Cytodyn shall expect a 12-25% mortality in its placebo arm, making the trial a failure
8/ First here is the study. is based on 65 US HOSPITALS, early pandemic (March-May), across all US regions (West Coast to East Coast, North to South). I encourage you to read it, particularly the "supplement" PDF. Fast readers, I will also help you
Study link
9/ It had 2215 patients of which 784 died, so a 35% mortality indeed, everything is consistent with the longs’ figures. What is more interesting is how they map to « Severe » and « Critical » $CYDY trial criteria…which are snapshotted below - I will help you read these too
10/ The US ICU study had (read below) 67.4% invasive mech. vent., 1.2% non-invasive mech. vent. and 18.5% high-flow NC or non-rebreather mask. These are all criteria for $CYDY « Critical » patients, not « Severe » ! That’s already 87.1% !
11/ Add in a tiny chunk of the 48.3% patients on vasopressor (also a criteria for «Critical» $CYDY patients, clearly not «Severe») and you end up with 90%+ patients in ICUs which CANNOT BE Severe patients for Cytodyn.That shows ICUs are not very representative of Cytodyn’s trial…
12/ But the most interesting is not that. Remember Cytodyn accepts only patients with PaO2/FiO2 > 150 mmHg (better breathing patients). Now look at the table red values below: median value and 25% and 75% quantiles. Most of these patients would not be accepted by $CYDY !
13/ Excluding the patients that Cytodyn would exclude, and keeping the other ventilation lines unchanged, allows us to estimate an equivalent mortality rate of roughly 30 to 32% for ICU patients that would be accepted by $CYDY
14/ Let’s keep 32% to be conservative (but 30% will make thing much worse for Cytodyn). Remember ICU patients are mostly « Critical » for $CYDY . We need to mix in « Severe » patients. Research papers tell us their mortality is roughly 8-12% with a mix of 1/3rd to 2/3rd of Severes. That gives us a combined mortality of 17-25%
15/ Which is completely aligned with the 50+ research paper we had reviewed previously. This is our expectation of $CYDY placebo arm mortality for Severe/Critical COVID patients…
16/ Which, given the trial combined deaths revealed by $CYDY CEO on Jan. 6th conference call (87+ deaths), would make the COVID trial a VERY PROBABLE failure
17/ Note: some people have pointed out that mortality might have gone up in December, eg UCLA. We DID analyze that and no, it would be minor (doesn't impact the figures a lot) and could not support in our opinion a $CYDY success
18/ Here is the synthesis again - remember, $CYDY has failed ALL its regulatory approvals before, despite countless promises and « impressive results » PRs. Who remembers Thailand, Mexico, UK, Canada, Philippines, Cancer, BBB, Nash, HIV BLA, Remdesivir+Leronlimab, etc…
It is not possible that they are in a worse shape because...Cytodyn excludes the ones with a worse shape!
As I have shown in my post, patients with a high respiratory distress, typical of nearly 60% of ICUs patients, are excluded by Cytodyn. They only keep the « mild » critical cases. That puts a ceiling on the mortality rate. Even if ALL patients were at this ceiling (which is not possible either but for the sake of it let’s just imagine), the primary endpoint would still not be statistically significant. It’s game over...
But your Cytodyn mortality number is not compatible with the 65 US ICUs statistics, West Coast to East coast, North to South...if I use your number, the placebo arm would end up having a higher mortality for Severe+Critical patients than what all these ICUs have with Critical+Overcritical patients...and 50+ independant global studies confirm the US ICUs numbers... they are all consistent together, taken from different countries, while your number is not.
Regarding the EIND papers, you realize they suffer from important methodological biases? Like some patients handpicked (or, conversely, non included) from the papers. Such biases make the number non representative. Also with so few patients the numbers you quote are not statistically significant. With 2000+ patients (and much more if you include the other 50+ global studies), the ICUs study figures are MUCH more precise and significant. Taken together, huge biases + small pop., the EIND papers are not very useful. This is phase III, FDA is looking for hard statistics, not a couple EIND anymore.
Excepted my analysis shows that the pending COVID trial is about to fail exactly like its predecessor:
Full details
And...he cannot uplist to NASDAQ with his negative Stockholders' Equity. I can repost that precise analysis if you wish.
My analysis indicates 50 to 60% of ICU patients are excluded by Cytodyn's respiratory criteria, too distressed.
That's really bad for Cytodyn. The calculation means Cytodyn's mortality in the placebo arm will be FAR BELOW the required 35% mortality to have the trial hit statistical significance. Leronlimab has the same efficacy than ... saline. That is ... placebo. Considering all the expectations that have been piled up on the stock for COVID and their financial distress, I infer that they are about to crash.
The details you were looking for are right there:
Full thread
Excepted all the Cytodyn facts converge...to indicate IMHO that the "if" will never happen. It's the Titanic, loaded up with unmet expectations
As promised - why Cytodyn trial has failed in my opinion 1/As promised, here is why I believe Cytodyn's COVID CD12 trial will be a failure$CYDY pic.twitter.com/WQrutnXFjX
Wrong. He got shares prepartitioned in December at $3.4 a share already. Search for "prepartition" in the SEC filings. He really has the upper hand with regards to Cytodyn. I will post more about this, but the key remark is the following: in the coming 5 business days (so, this week), Cytodyn has to repay him an ADDITIONAL $7.5 millions. I expect a new prepartition.
Excepted if you get any of these in parallel:
- CD12 failure (like CD10 this summer: -40% in 4 weeks without Fife joining the party)
- One or several default events (Samsung Biologics, the company owes them >$40 millions now while Fife is owed $7.5 millions repayment every month)
Second, Fife (Streeterville capital's owner) shares are subject to "full ratchet" terms. So the 0.35% computation is wrong. This will grow if the stock price goes down and the company raises capital through stock sales. That means, if any of these occur, Fife has a good chance to benefit from a re-adjustment downward of his conversion price as the price falls, multiplying in effect by as much the shares due to him...this term has no limit. This is what "toxic" means. He could even short the stock in parallel if he were to be naughty
Last, if any default event occurs, Fife gets additional value again. Read the contract, these are listed as "major" and "minor" default event conditions.
This is what "toxic" means.
Based on what we all saw in early November, this is largely enough to trigger a CYDY stock panic and trigger all stop loss orders down to -30 to -50% fall. If this happens this will not be due to short-sellers...but to the company's financier. And this is only a chunk corresponding to his December repayment. He has 5 other months like that in his sleeves. Plus the full ratchet terms that will dilute these millions even more.
Hello,
your copy & pasted block of text seems to be the one we can see for Cytodyn's CD12 trial on clinicaltrials.com.
If this is the case, yes this is what I used to perform the mortality estimate analysis. The inclusion/exclusion criteria lists are quite long and there are a couple subtleties that are not obvious. I encourage everybody to read them carefully.
More to come today.
Nader Pourhassan, Cytodyn CEO, broke a promise again
This press release by Cytodyn said the pending COVID CD12 trial results would be posted mid-january:
"...trial for the severe-to-critically ill COVID-19 population and expects to release results in mid-January 2021."
Yet we are end of January and no news from the company.
Another fail. But I guess we will get some long haulers or cancer news: the Merry Go Round trick.
Wrong, the group « stays » identical because it is assigned for each patient at the beginning of the treatment..I just follow the rules defined by Cytodyn in its CD12 trial specifications.
I believe Cytodyn's data is insufficient to obtain CD12 approval.
I have currently no opinion on RLFTF.
Like Thailand? Mexico? Or the Philippines?
Canada? Or the UK?
They had in the end zero confirmed interest in Cytodyn to approve or acquire any asset, despite overly optimistic press releases.
My opinion is that Cytodyn is a Merry Go Round fraud. Always a new shiny thing to suggest through PRs.
Incorrect. The trial criteria have been organized and worded by Cytodyn in a very smart way. Important things hard to catch there in my opinion. I will explain tomorrow where is the trick. Based on the US ICU research paper, it does exclude a lot of ICU patients. More than half of them.
This kills the thesis that Leronlimab may be most useful for the most critical patients. It can’t because these patients have been excluded from the Cytodyn trial. And it kills any hope that the trial placebo mortality could approach ICU mortality. It can’t, Cytodyn has removed all the high-risk cases. And added all the non-ICU cases (severes mostly) which will drastically lower the placebo mortality rate.
This is in my opinion very bad for Cytodyn.
A synthesis of our upcoming CD12 trial failure estimate - more details on Monday
Cytodyn is in a very bad shape and we believe this explains why they are not disclosing simple statistics (mortality for each arm) publicly. We think their only solution is to datamine (overfit) the dataset to report any random coincidence as a « win », just like the previous CD10 Covid trial which was a complete regulatory failure (stock lost -40% in the following 4 weeks).
A synthesis of our estimate of Cytodyn's COVID trial mortality:
A synthesis of our estimate of Cytodyn’s CD12 trial placebo arm - the research paper we used to estimate it is fully consistent with the 50+ papers we reviewed before - more details on Monday as previously announced$CYDY pic.twitter.com/SX7Sd0Sjn0
— kgromax (@kgromax) January 24, 2021
I would like to thank you for using this study, that's one I had kept aside for later...
Digging deep into the guts of this very same study, I will prove Monday 4 points for Cytodyn's trial:
(1) ICUs contain less than 10% of the milder patients (called "severe" by Cytodyn), not 33% as you suggest
(2) To the contrary, 55 to 60% of their patients are way too critical and excluded from Cytodyn's study (excluded by their criteria, too much risk) - this proves quantitatively a point I have been making many times that this trial doesn't address high-risk patients, no hope there
(3) The consequence is that ICU mortality is way above what Cytodyn could expect for trial placebo patients - adjusting for these 2 differences above, this study proves that the mortality of Cytodyn's "critical" patients shall be around 32% only
(4) Keeping your pessimistic severe/critical ratio assumptions, this will result in a placebo mortality of 25% - or 21% if we split 50/50% the severe/criticals - or 17% if we align on the average of the mixes reported by all worldwide research papers
Meaning, once again and whatever the mix chosen, that Leronlimab, with 2/3rd of patients in a trial with 22% combined mortality, performs not differently than placebo. Like saline.
Exactly in line with the previous Cytodyn COVID trial which got absolutely no approval in the US nor in any country worldwide. We had predicted there again based on statistics that it would be a total failure despite the huge positive press releases by the company...Numbers don't lie and must be used to weight every medical theory, even the most attractive ones.
Stay tuned, this explains why the CEO is not disclosing to shareholders the trial mortality information that is sitting on his desk.
Pestell as the boss of this paper happens to be ... Cytodyn’s Chief Medical Officer. Far from independent, he is one of the organizers of the Merry Go Round.
He decided to release that paper with the CEO (Nader Pourhassan) while they were supposed to disclose the pending COVID trial result.
If that is not clear...
Merry Go Round.
I am just comparing Cytodyn’s regulatory outcome (zero FDA aproval, same in every other country) with what was predicted by its shareholders as a « sure win ». And observing a wide discrepancy there. Retail investor education about pump & dump fraud companies (like Cytodyn in my opinion) is indeed necessary in financial markets.
In this case it was indeed not the lack of results of the Cytodyn phase II trial (that I had predicted based on statistics) that was the issue, but the widely unrealistic expectations of success that had been generated by promotion firms paid by Cytodyn. They are listed in the quarterly reports. More than 12 promotion firms, which is staggering for a biotech (clinical results usually are the best promotion).
I predict the same unrealistic expectations have been generated for the pending phase III. The loss of shareholder capital will be tragic as the company insiders and its toxic lenders have been dumping stock on them and overpromising fairy tales.
So we are in agreement.
Cytodyn is just like Theranos. Same number of regulatory approvals, same IP, same achievements at the end of the day. Same fraud.
I agree that it's an extraordinary thought, to think that Cytodyn would not have thought about and/or been capable of collecting and presenting proper assay data to the FDA, something that seems so obvious. If I were the FDA I would be really surprised by such an obvious mistake. I think that's why they rejected the initial HIV BLA filing. It's fishy and the FDA will be even more careful going forward with anything they present. Bad behavior and bad reputation doesn't help biotech firms.
Thank you SmileyRiley. I infer that Cytodyn is just like Theranos.
This doesn't change my reasoning. The doses required for a monthly injection are not in the vicinity of current doses and thus are pure speculation from the company both from an efficacy standpoint and an SAE standpoint.
Additionally, what is interesting is that this paper linked doesn't measure the half-life nor shows any data. It just talks about "internal estimates". No table, no chart, no measurement, nothing. I know many other Cytodyn estimates, e.g. that Leronlimab had "impressive results" in the previous COVID trial, with the ensuring disaster we all remember. Whereas the previous 3.x estimates all come from various clinical databases after having been duly disclosed in appropriate studies.
Why is that interesting? Because it touches the current issue with the HIV BLA. It seems the company is unable to prove what's going on with the current doses of Leronlimab, both from a half-life standpoint and receptor occupancy standpoint. Said differently: the elephant in the team room is that it seems the company has not checked how Leronlimab interacts with CCR5 for the trial patients, or if it has, the information is mysteriously missing from an FDA standpoint. I quote Dr. Bruce Patterson, a few days ago on Twitter:
You don’t think blaming the BLA delay on IncellDx’s RO assay when we didn’t even run it in the combo trial and only a third of the mono trial is bad? It is so critical in all CCR5 trials because of the variation in CCR5 level day to day.
Even the required doses with that half-life would be a high multiple of what has been tested. They are still testing with bi-weekly and weekly injections...the difference is so high adjusting the half-life doesnt change the issue
You can look it up, Cytodyn has published these facts on the I.N.T.E.R.N.E.T. Open your IBM Personal Computer. Type google.com. Type in the field "leronlimab half-life". Click on one of the links.
With a half life of 3.7 days there is no chance Cytodyn can validate any monthly injection of Leronlimab based on the past trials. That would require very roughly 33 times higher doses than anything they have tested before. Just ouf of the tested bounds by a huge margin regarding efficacy & SAE. This is pure speculation once again from company's management without any serious data to back it up.
Management lovse dropping hints like that, without any scientific basis, because they know such lies work.
Sorry that was very clear. A sample size reassessment is a specialist's operation that isn't done just because it can be done, particularly in a new interim that was not planned initially, with the statistical penalties incurred to perform that new interim review.
It's a matter of legal opinion and interpretation and I would not be surprised if they try to play tricks there. The primary endpoint may have failed but the CEO and his counsel could try to argue that, until they have clarity on the secondary endpoints analysis (datamining!), the material event is not "complete" and thus that they had to wait. I don't believe that logic stands and I think any class action lawsuit would try to find an angle there, but I would not be surprised if they try such things. Because they have always postponed as much as they could all the bad news they have accumulated over the last couple years, on every topic, in sometimes very tricky ways (eg dissimulating bad news at the end of unrelated press releases, or in the middle of a long 10-Q filing).
As I already wrote, the DSMC did request a new 75% interim and did request to extend the mortality measurement from 28 to 42 days.
These are professionals and they did that only because they were forced to.
It is Cytodyn's CEO, Nader Pourhassan, who refused to follow this recommendation.
I already detailed these points, anybody can read in my history.
I disagree. most biotechs dont have toxic loans like Cytodyn. Most don't have history of over-promising so much. They are not radioactive (shady reputation) nor poisonous (poison pills preventing an acquisition). That makes them very attractive for a potential buyer, because he can trust that he will be able post-acquisition to perform the transactions he needs to bring them to fruition. In Cytodyn's case, there are red flags everywhere. And who knows what has been kept hidden from the public in the drawers.
When Cytodyn's former Chief Medical Officer has a lawsuit, accusing the CEO of exagerating and lying to his own shareholders about the reality of the company, this is hair-raising to any professional investor or acquirer.
A simple statistic, someone called that the "Nader constant failure model": he made more than 30 enthusiastic press releases over the last 3 years. Yet, none of them have been delivered. By delivered, I mean a regulatory approval. 0%. That is not what I see with most biotechs. They may not deliver but PRs are very limited in number, choice of superlative adjectives, carefully worded and not crazily positive. Also most of these startups don't deal with Fife the toxic lender.
This is a very toxic combination and Cytodyn has it. It's I believe a mini-Theranos
Well the good news once a Cytodyn trial is completed is that data tells everything. Scientific theories, like Leronlimab hypothetical mode of action, can all be tested and data measured to assess if they stand correct or incorrect.
It seems odd to me that Cytodyn's CEO, the man who pushes out PR about anything positive, even a conf. call with the FDA, is mysteriously unable to share deaths totals per arm from the data that has been sitting on his desk for quite some time now. This is not the man we know. Only one explanation: the data is horrible and he needs time to datamine it with his team to find any spurious correlation he could "sell" as a win. However last time he tried that, with the previous COVID trial (CD10), the stock crashed -40% in a couple weeks. The market saw through it. Theranos.
Yes but it comes back once again to Leronlimab success or failure. It shows there is no other hope: NASDAQ is saying no otherwise. SPAC buyers would be saying no otherwise. In fact, the company, if it cannot prove anything good with Leronlimab, is radioactive (reputation) and poisonous (legal terms) for any third party
I agree these facts have an apparent contradiction.
The "bug" comes simply...from Cytodyn's market cap. It bears no relationship to any other element. Once the pump & dump Merry-Go-Round fraud is stopped, it should be $200 millions maximum provided they manage to escape the toxic loan. However I believe they won't be able to escape it.
Yes I thought about that. I think their balance sheet and toxic loan act like a poison pill to any buyer. The toxic loan terms make unattractive many, many future potential transactions a buyer could wish to perform after the acquisition. These terms are detailed in the last 10-Q and several filings before.
Wrong due to the Cytodyn facts I already quoted, from the CEO itself:
"sample size reassessment".
Cytodyn stock is crumbling. Facts are facts
Thats precisely the trick used by Cytodyn:
They make very positive PRs.
And, because they would be legally liable otherwise, they disclose the bad news or real issues in hard-to-reach sources:
conference calls, last line of unrelated (very positive again) later PRs dealing with another trial, guts of the quarterly report that is 40+ pages long.
Conference calls and SEC filings are key. And the tiny details and last lines of every PR.