***OFFICIAL CYDY/Leronlimab Thread*** (1 Viewer)

[Chaz McNulty]

It's a fair point, that things could have changed statistically from 50% to 75% where they may have recommended a modification.  It happened with HGEN.  

He also makes a fair point about the 42 day review.  The DSMC obviously saw something where they thought there was benefit to a 42 day endpoint.

The argument on this is that the 42 day endpoint may have been necessary at 75% to achieve statistical signifcance but perhaps at the full trial size, it wasn't necessary.  We really don't know either way on this, I would say that it was a calculated risk on Cytodyn's part not to review this.

I believe the 75% review would have happened if not for the speed at which the trial concluded.   It only took 2 weeks from 75% to conclusion, and the company decided to just go with the completed trial.

 

[Don Hutson]

For what reason wouldn't they recommend trial size expansion at 50%?  If they thought that was an issue, what benefit would there be to waiting until 75%?

I'm not sure

The argument on this is that the 42 day endpoint may have been necessary at 75% to achieve statistical signifcance but perhaps at the full trial size, it wasn't necessary.

They recommended adding the endpoint at the 75% for future patients, not for past patients.  You couldn't add that end point for patients already in the trial and they were already past the 50% point.  Pretty clearly, they were anticipating that the trial would end up more than 390 patients.  In other words, phase IV.

 

[Dwayne Hoover]

One thing that Don did leave out is that it was also possible at 75% that the DSMC could have deemed that Cytodyn had achieved statistical significance and recommended to stop the trial.  We can't assume that there would have been a modification so I do differ with Don there.  He insinuated that the reason for the 75% review was for a modification but we don't know that at all nor can we assume that.

 

[Dwayne Hoover]

I'm not sure

They recommended adding the endpoint at the 75% for future patients, not for past patients.  You couldn't add that end point for patients already in the trial and they were already past the 50% point.  Pretty clearly, they were anticipating that the trial would end up more than 390 patients.  In other words, phase IV.

This isn't right.  The data was blinded to everyone but the DSMC so it could be applied to current patients.

 

[Dwayne Hoover]

I believe the 75% review would have happened if not for the speed at which the trial concluded.   It only took 2 weeks from 75% to conclusion, and the company decided to just go with the completed trial.

Yeah for sure, but there was still a risk that they missed a point where they could have gotten recommendations

 

[Don Hutson]

This isn't right.  The data was blinded to everyone but the DSMC so it could be applied to current patients.

You can't retroactively add an endpoint.  You especially can't do it with patients already past 42 days and some of the patients beyond the 50% point were already 42 days past enrollment.  The modifications would have only applied to patient 293 and beyond.

 

[Dwayne Hoover]

You can't retroactively add an endpoint.  You especially can't do it with patients already past 42 days and some of even the patients beyond the 50% point were already 42 days past enrollment.

I don't think you are correct about this.  Why can't they retroactively analyze at 42 days whether the patient is alive or dead?

If the data was unblinded, then sure

 

[Don Hutson]

I don't think you are correct about this.  Why can't they retroactively analyze at 42 days whether the patient is alive or dead?

If the data was unblinded, then sure

Because they didn't gather the information because it wasn't part of the trial.  Modifications to the trial affect patients not yet enrolled.

 

[CGRdrJoe]

Man a lot of doctors and pharmaceutical experts in here now, webmd and google offering Doctorates now I guess

 

[ChiefD]

CYDY moving up. In your face negative nancy's!

 

[Capella]

CYDY moving up. In your face negative nancy's!

Weekend cover time 

 

[ChiefD]

CYDY moving up. In your face negative nancy's!

Nevermind.

 

[Dwayne Hoover]

Man a lot of doctors and pharmaceutical experts in here now, webmd and google offering Doctorates now I guess

Not pretending to be an expert but sorry if that offends you that we are trying to flesh this out, kind of important.  There has been so much great insight in here otherwise.

Anyway, this is exactly what Cytodyn said:

"DSMC also requests another data review when enrollment reaches 293 patients (75%) to analyze all data, including survival rate at 42 days"

 

[Dwayne Hoover]

Because they didn't gather the information because it wasn't part of the trial.  Modifications to the trial affect patients not yet enrolled.

Not for nothing but Remdesivir changed their primary endpoint when the trial was over and it included a spilover arm of previously enrolled patients.   Pretty sure you are wrong about this but if you can prove it out otherwise, would be great to see.

 

[chet]

Anyone heard the conspiracy theory about Samantha Mottet?  Her and Nader lived 2 miles away from each other.  They had daughters the same age who both ended up majoring in math at university.  In a small town of 39,000.  Samantha's husband is a venture capitalist known for shady dealings.  Oh, and Samantha once went to prison for trying to kill her husband with an axe.  You can't make this stuff up.  I'm not saying it was aliens, but it was aliens.

This is beyond ridiculous.  It's one thing to have doubts about the company but please stop repeating the lies that the shorts are spreading. 

 

[Chaz McNulty]

As long as we get no news item about a future CC, then I like where we are.  

I also think if they knew the trial was a failure, the news would come out on a Friday afternoon to soften the blow.

 

[SouthJersey]

How do we get WSB to champion CYDY the way they have pumped GME?

 

[Dave RL]

Have a good weekend everyone! Hopefully next week will be less uncertain on the future for CYDY. (How's that for walking the fence )

 

[Don Hutson]

This is beyond ridiculous.  It's one thing to have doubts about the company but please stop repeating the lies that the shorts are spreading. 

What is the lie?  I have verified all of the information given.

 

[chet]

What is the lie?  I have verified all of the information given.

Saying that Mottet is part of a grand conspiracy and her recovery was faked.

 

[Chaz McNulty]

What is the lie?  I have verified all of the information given.

Why bother bringing that here?  It's something you expect to see on the Yahoo boards.

They might know each other?  Really.  And they might not.

 

[Dave RL]

Can we end this?

1) The details if true still do not prove collusion.

2) If LL were not working the DSMC would have ended the trial.

3) CD12 Results will soon answer all questions. 

 

[unckeyherb]

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=161132971

From Investorshub:

Credit to Dr. Ross off another board- This is true Due Diligence and knowledge!!

I would like to share some statistics with you that have a bearing on the likely outcome of the CD12 trial. I am a doctor who is part of a large hospital network. In our state right now, the most recent statistics show that 67% of the patients in the ICU are on mechanical ventilation. That would place them in the critical category for the CD12 trial. This is an important statistic because we know that the mortality rate in this population was reported to be as high as 80% in the beginning of the pandemic and is probably still at least 35% or higher. If we assume that most or all of patients enrolled in CD12 came from the ICU you can apply the following math:

394 patients in trial
67% critical and 33% severe
394 x 0.667 = 262 critical patients
394 x .333 = 132 severe patients

Now, conservatively assume 40% mortality rate in critical and 15% in severe
262 Critical x 40% mortality rate = 105 expected deaths
132 Severe x 15% expected mortality rate = 20 expected deaths

Total deaths should have been 105 + 20 = 125 for a 31.7% death rate if Leronlimab did not work at all and placebo group was the same as treatment group. Instead, we saw 87 deaths. Assume 90 total since people may have died after we were told 87. That means we had 35 fewer deaths than expected.
The ratio of LL to placebo was 2:1 in the trial, so the number of people treated was 262. Expected deaths in the treatment group is 262 x .317 = 83. However, according to our calculations, we had 35 fewer deaths than expected. If this difference was all due to Leronlimab, the actual deaths in the treatment group were 83-35=48. That would leave 42 deaths in the placebo group. These number represent a statistically significant difference with p<0.05.
Since these are conservative estimates of mortality in each group, this is another indication that we will get very good results from CD12 IMO.

 

[chet]

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=161132971

From Investorshub:

This post addresses some of the key questions.  Good find.

 

[Charlie Harper]

It honestly just boils down to what mortality rate you want to apply. Anything less than 28% doesn't reach significance based on the online calculator I used. We've seen anywhere from 18% to 40+% in other studies....so we're pretty much a coin flip IMO.

 

[Dwayne Hoover]

It honestly just boils down to what mortality rate you want to apply. Anything less than 28% doesn't reach significance based on the online calculator I used. We've seen anywhere from 18% to 40+% in other studies....so we're pretty much a coin flip IMO.

The severe and critical breakdown is directly related to this and since we don't know the breakdown, hard to figure the mortality..  More critical definitely means higher mortality.

 

[Chaz McNulty]

It honestly just boils down to what mortality rate you want to apply. Anything less than 28% doesn't reach significance based on the online calculator I used. We've seen anywhere from 18% to 40+% in other studies....so we're pretty much a coin flip IMO.

Agreed.  I think it will be close.  Saying that, a 20% reduction in death might not get to the .05 p-value needed, but it is probably still the best option people in severe condition have.

 

[Don Hutson]

Agreed.  I think it will be close.  Saying that, a 20% reduction in death might not get to the .05 p-value needed, but it is probably still the best option people in severe condition have.

No miracle drug has been found.  It's going to be interesting if it can get an EUA without a p-value of .05.  It being such a mild drug without SAEs will help it.  I know I would want to take it if it improved my chances of living by 20% over the SOC.  Dr Yo's analogy of the toolbox is a good one for this where a doctor might have a bunch of different drugs of which none are great but each can help.  Maybe each day a different drug is used until one helps.  Obviously, Nader being a greasy buffoon and leronlimab being expensive might prevent an EUA with only marginally good results.  Phase IV is then a possibility.  It'll be interesting what happens to the stock price if a phase IV is the FDA's ruling.

 

[Don Hutson]

Anyway, this is exactly what Cytodyn said:

"DSMC also requests another data review when enrollment reaches 293 patients (75%) to analyze all data, including survival rate at 42 days"

Here is what Nader said in the conference call:

“The DSMC recommendation was to continue the trial as planned but to conduct another interim analysis when 75% of the planned subjects have been randomized and have been under study for 42 days, or withdrawn, which ever occurs first. Sample size reassessment will be considered at that interim analysis.”

A sample size reassessment would happen because the study didn't have enough patients to achieve statistical significance.  They would not be considering increasing the number of patients if they believed that the study was going to succeed in its current format.

 

[Don Hutson]

Saying that Mottet is part of a grand conspiracy and her recovery was faked.

Strawman.  Not a single person is alleging that she faked her Covid.  They speculate that she might have had financial incentive to promote leronlimab.  Her promotion of leronlimab was extremely enthusiastic and constant.  Her and Nader living in the same small town is a big coincidence.  Her husband is a shady venture capitalist.  It is not farfetched to think that there might be a connection.

Any time there is not 100% definitive proof, longs will then say it is 100% false or a lie.  There are probably 100 posts about Mottet in this thread.  She was very effective at pumping leronlimab.  Nader is greasy.  This stock is greasy.  I guarantee that Nader would be willing to pay someone like Samantha to pump it. 

The odds of Nader and associates getting in trouble with the SEC is greater than leronlimab getting an EUA at this stage.  And when you tell the impressionable people here that leronlimab has an 80%+ chance at an EUA, it makes you seem greasy, too.  You are either delusional or lying.  Take your pick.

 

[Dave RL]

I'm not worried in that case. I'd welcome someone with more experience in biotech leading Cytodyn. I don't think it would have more than a blip on the SP either. 

 

[Don Hutson]

For those who believe that results are not intentionally being delayed because they are mediocre, the December 15th press release that stated that the trial was completely enrolled said:

https://www.globenewswire.com/news-release/2020/12/15/2145741/0/en/CytoDyn-Completes-Enrollment-for-Phase-3-Registrational-Trial-for-390-Patients-with-Severe-to-Critical-COVID-19.html

CytoDyn completed enrollment of 390 patients in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population and expects to release results in mid-January 2021.

 

[Dwayne Hoover]

Strawman.  Not a single person is alleging that she faked her Covid.  They speculate that she might have had financial incentive to promote leronlimab.  Her promotion of leronlimab was extremely enthusiastic and constant.  Her and Nader living in the same small town is a big coincidence.  Her husband is a shady venture capitalist.  It is not farfetched to think that there might be a connection.

Any time there is not 100% definitive proof, longs will then say it is 100% false or a lie.  There are probably 100 posts about Mottet in this thread.  She was very effective at pumping leronlimab.  Nader is greasy.  This stock is greasy.  I guarantee that Nader would be willing to pay someone like Samantha to pump it. 

The odds of Nader and associates getting in trouble with the SEC is greater than leronlimab getting an EUA at this stage.  And when you tell the impressionable people here that leronlimab has an 80%+ chance at an EUA, it makes you seem greasy, too.  You are either delusional or lying.  Take your pick.

You are too confident and you don't know anything either.  You've had some bad reads lately, starting to feel like you might be having another one here.  At this point, the more you post with confidence that it's not going too happen, the more bullish I get.

 

[Chaz McNulty]

Impressive what it can do to mice with TNBC.  Lets hope it translates to humans.

https://breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-021-01391-1

 

[Dwayne Hoover]

For those who believe that results are not intentionally being delayed because they are mediocre, the December 15th press release that stated that the trial was completely enrolled said:

I'm not saying it's great that we haven't got any news if results are good, I do see it as a red flag too, but also acknowledge that there are still reasons why they may not be ready.  Cytodyn has never been great with their timing estimates so it's also not surprising that it may be later than projected.

 

[Taxguy]

For those who believe that results are not intentionally being delayed because they are mediocre, the December 15th press release that stated that the trial was completely enrolled said:

I read your link and no where did it say ‘mid- January’

Here’s the actual quote from the article you linked.  Doesn’t specifically say ‘mid-January’ so not sure why you laid it as you did.

VANCOUVER, Washington, Dec. 15, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it had reached full enrollment in its Phase 3 registrational trial for patients with severe-to-critical COVID-19. The 390-patient data will be analyzed in approximately 28 days, with expected results to be announced shortly thereafter.

 

[Don Hutson]

I read your link and no where did it say ‘mid- January’

Click on the link.  Simultaneously press the "ctrl" button while pressing the letter "f".  Then type mid-January in the box provided.  Voila!  It will bring you to the part of the pr that I quoted.

 

[Dwayne Hoover]

I think Don Hutson has had some valid criticisms and at times brings things up that I question myself.  This week though he's getting further from the reservation.

The Samantha Mottet potential links to Nader are interesting but don't mean anything.  The most important thing to recognize is that she was on a ventilator, Dr Otto Yang recommended leronlimab and she recovered quickly.  This is the truth so any of the other stuff is meaningless. It's a pretty amazing story in leronlimabs favor.  Unless you think Yang is on the conspiracy too, probably should drop the noise.

I see no point in attacking Chet. From what I can tell Chet has been pretty dialed in here. I can't think of any cases, unlike Don, where he has been wrong about CYDY. The greasey comment is laughable but I believe that Chet is as confident as he says and us not trying to lead anyone astray.  Sure, he may not be right in the end but really nothing I can see to call him into question.

 

[Don Hutson]

I see no point in attacking Chet. From what I can tell Chet has been pretty dialed in here. I can't think of any cases, unlike Don, where he has been wrong about CYDY. The greasey comment is laughable but I believe that Chet is as confident as he says and us not trying to lead anyone astray.  Sure, he may not be right in the end but really nothing I can see to call him into question.

Chet pumps.  He owns/owned shares that are/were locked.  He has never been forthright with his opinion.  Cav says that Chet was upset with him for Cav telling us what his daughter thought that about the M2M trial results.  Cav's daughter is an expert.  She does trials on pharmaceutical drugs.  So Cav was supposed to not tell us her opinions because they did not reflect well on leronlimab?  Greasy.  I sold because of what Cav's daughter said and I will be eternally grateful that Cav did not keep that information secret.  Another one is how Chet is always telling us that he knows that leronlimb works because he has insider information about its efficacy.  He can't tell us what that information because it is secret.  On the other hand, when it is suggested that Michael Mulholland might have sold his shares because he has insider information, Chet says it is highly unlikely that Mulholland could have insider information.  So Chet has insider information but the Chief Financial Officer who works in a small office with Nader doesn't have insider information?  Of all of the numerous red flags, the fact that the top 3 people in CytoDyn have all sold millions of shares is the biggest.

Long and Strong

 

[Dwayne Hoover]

Chet pumps.  He owns/owned shares that are/were locked.  

Where do you come up with this stuff? 

 

[stbugs]

Man, I check in here every once and a while and I am so glad I’ve been out for a while. Thanks again to Chet for paying for some of my kid’s college (was 4 years at peak, ~2 years after selling after peak). This thread was so much fun until that bear raid and it’s definitely not anymore. 

 

[Capella]

I need this to go to the moon or zero so I can stop reading this crap. 

 

[Don Hutson]

This Ihub post from "kgromax" is pretty persuasive.  Leronlimab's study excluded the worst of the critical patients.  So any study showing the mortality rate of critical patients isn't an exact correlation.  Is it possible for the placebo arm to have a 28%-30% mortality rate when severe patients were included but the worst off critical patients were excluded?

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=161144611
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.

 

[Dwayne Hoover]

This Ihub post from "kgromax" is pretty persuasive.  Leronlimab's study excluded the worst of the critical patients.  So any study showing the mortality rate of critical patients isn't an exact correlation.  Is it possible for the placebo arm to have a 28%-30% mortality rate when severe patients were included but the worst off critical patients were excluded?

Now you are quoting a guy who is 100% anti cytodyn. Virtually unreadable.

I'm getting more confident about cydys chances if this is where you are at

 

[Don Hutson]

Now you are quoting a guy who is 100% anti cytodyn. Virtually unreadable.

I'm getting more confident about cydys chances if this is where you are at

It is unreadable to you because you are offended by anti-CYDY beliefs.  It would be the same as a Christian reading an atheist's thoughts.  They won't be openminded and will insult the source.  kgromax and justdafactss are definitely anti-cydy but the Longs on the message boards are just as biased.  And the Shorts definitely support what they say more than the longs.  I read what both Longs and Shorts have to say and separate the wheat from the chaff.  The above post by kgromax is wheat and you are gluten intolerant.

 

[CGRdrJoe]

This Ihub post from "kgromax" is pretty persuasive.  Leronlimab's study excluded the worst of the critical patients.  So any study showing the mortality rate of critical patients isn't an exact correlation.  Is it possible for the placebo arm to have a 28%-30% mortality rate when severe patients were included but the worst off critical patients were excluded?

He’s the same guy that went full court press against overstock.com, didn’t work out so great for him on that one.

 

[Don Hutson]

He’s the same guy that went full court press against overstock.com, didn’t work out so great for him on that one.

I drafted David Wilson in every one of my drafts in 2014.  

 

[Capella]

This Ihub post from "kgromax" is pretty persuasive.  Leronlimab's study excluded the worst of the critical patients.  So any study showing the mortality rate of critical patients isn't an exact correlation.  Is it possible for the placebo arm to have a 28%-30% mortality rate when severe patients were included but the worst off critical patients were excluded?

From yahoo; kgroMax tweet dates, prices and performance since 'expert' recommendations: 

1/30/20 APT closed at $6.24, 52 week high of $41.59, currently $13.73 

1/30/20 LAKE closed at $13.82, 52 week high of $31.95, currently $27.18 

1/31/20 OSTK closed at $8.12, 52 week high of $128.50, currently 64.41

Lmfao

 

[Don Hutson]

From yahoo; kgroMax tweet dates, prices and performance since 'expert' recommendations: 

1/30/20 APT closed at $6.24, 52 week high of $41.59, currently $13.73 

1/30/20 LAKE closed at $13.82, 52 week high of $31.95, currently $27.18 

1/31/20 OSTK closed at $8.12, 52 week high of $128.50, currently 64.41

Lmfao

You are attacking the source instead of his argument.  Do you believe that the placebo arm could have a 28%-30% mortality rate when the trial included severe patients but not the worst of the critical patients?

 

[Capella]

So are you attacking the source instead of his argument.  Do you believe that the placebo arm could have a 28%-30% mortality rate when it included severe patients but not the worst of the critical patients?

I don’t have an opinion because this is nowhere near as important to me as it is to you. Either it hits or it doesn’t, the kid still gets up at 6:30 every day either way. 
 

And LOL at “attack”. It was copied from the yahoo board.