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***OFFICIAL CYDY/Leronlimab Thread***


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13 minutes ago, Dwayne Hoover said:

IDK, what if the data is borderline

Only good news can't be reported?  If the issue is that they are still talking with the FDA confidentially about the data, this could apply to borderline as well, then seems like its the same scenario

Im not an expert but I'll weigh in on with the other non experts that post this stuff

We may not be experts, but I can guarantee that anyone that's been along for this ride knows a whole lot more about the FDA, Trials, Approvals, BP, Virology, Snake Oil Salesman, Shorting, and the CCR5 receptor, then we did a year ago.

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Yes, go ahead FC42

I closed.  Cydy operation mountain house completed.

Told my wife I was about to buy some more and she said that’s what I’ll get to keep in the divorce proceedings 😂😂😭😭😤

7 minutes ago, Chaz McNulty said:

We may not be experts, but I can guarantee that anyone that's been along for this ride knows a whole lot more about the FDA, Trials, Approvals, BP, Virology, Snake Oil Salesman, Shorting, and the CCR5 receptor, then we did a year ago.

Very true..

Just tired of some of the armchair experts, mainly on Yahoo which I check out too often, that have some faulty logic.

They all parrot the same thing, "if the data is bad than we would know already, therefore the data must be great"

I hope they are right but you can't just completely leave out the in between

Edited by Dwayne Hoover
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1 hour ago, unckeyherb said:

From Ihub:



Basically, unblinding on Monday + 4 days is Friday.  If we don't hear bad news by then, then the data is presumably good.

Data has been unblinded for weeks already. 28 days of phase 3 was Mid January. It doesn't take a month to unblind it. Again, the RFTLF study finished enrolling 5 days after and had data 2-3 weeks ago. 

Either AMARAX is the worst company you can hire for data analysis or NP is up to something.

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GME up over $100 after hours.  Shorts will likely be getting margin calls and could be doubly hurt with an approval announcement from CYDY.  If so, the upward move in CYDY might get exacerbated into something that looks like GME action.

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5 minutes ago, chet said:

GME up over $100 after hours.  Shorts will likely be getting margin calls and could be doubly hurt with an approval announcement from CYDY.  If so, the upward move in CYDY might get exacerbated into something that looks like GME action.

I imagine that the shorts are finally covering in GME right now.  It looks like there's still 40% shorted.  

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35 minutes ago, chet said:

GME up over $100 after hours.  Shorts will likely be getting margin calls and could be doubly hurt with an approval announcement from CYDY.  If so, the upward move in CYDY might get exacerbated into something that looks like GME action.

I can’t believe the GME thing. Again!! Fills me with joy. 

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WTF are the people in Florida doing?  From iHub:

Quote

Son just told me a friend in Tampa just got confirmed he has Covid for the 3rd time. Each time the side effects are less. He is early 40’s and single so in the bar scene. Covid most likely not going away too soon! 

 

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3 hours ago, chet said:

GME up over $100 after hours.  Shorts will likely be getting margin calls and could be doubly hurt with an approval announcement from CYDY.  If so, the upward move in CYDY might get exacerbated into something that looks like GME action.

GME went from middling $4-7 and then jumped to a high of $483.  Surely you aren’t suggesting that!  Or.....are you.

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11 hours ago, unckeyherb said:

GME went from middling $4-7 and then jumped to a high of $483.  Surely you aren’t suggesting that!  Or.....are you.

I don’t think it will have such an extreme move but I do think if there’s an approval, there will be a short squeeze which could be exacerbated by the margin calls the shorts are getting from the jump in GME. 

if the WSB crowd catches wind and jumps on board, all bets are off. 

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5 minutes ago, Dwayne Hoover said:

The Night King is up to his BS today

https://twitter.com/adamfeuerstein/status/1364931663944368128

Anyone have Stat News, I can't imagine he's saying anything groundbreaking but still would like to know

Quote

CytoDyn CEO Nader Pourhassan has been uncharacteristically quiet this week about a completed clinical trial involving patients with severe, life-threatening cases of Covid-19.

It’s uncharacteristic because Pourhassan has not been shy in touting the potential of CytoDyn’s only drug, an experimental antibody called leronlimab — not currently approved to treat anything. He has claimed leronlimab is capable of effectively treating HIV, 22 different types of cancer, fatty liver disease, multiple sclerosis, and Alzheimer’s disease, among other ailments. 

For years, CytoDyn’s stock price traded for pennies per share. But when the pandemic struck, Pourhassan started pitching leronlimab as a life-saving treatment for patients with Covid-19. His comments helped push the stock as high as $10 per share last year, giving the company a $6 billion market value. 

Last month, Pourhassan said CytoDyn’s stock price — $4 at that time — should trade in the “three or four digits.” At $100 per share, CytoDyn would be worth more than Moderna. At $1,000 per share, it would be worth almost as much as Johnson & Johnson and Novartis — the two largest health care companies — combined. Last year, CytoDyn had no revenue and more than doubled its net loss to $124 million. 

Pouhassan had been priming investors for weeks to expect results from a completed Phase 3 clinical trial designed to demonstrate that injections of leronlimab would improve the survival of patients with severe Covid-19 more than a placebo. He predicted that positive results from the study, known as CD-12, would spur the Food and Drug Administration to quickly grant leronlimab an emergency use authorization. And with that clearance, CytoDyn would be able to deliver billions of dollars in leronlimab sales, Pourhassan said. 

But on Monday, CytoDyn issued a cryptic statement about the CD-12 study: The leronlimab trial had been unblinded — meaning the study results were now known to the company — but would not be disclosed publicly. 

“We are eager to reach a conclusion in our discussions with all the regulatory agencies for the path going forward and will release the details of our data and the results of our discussions with regulatory agencies in the coming weeks,” Pourhassan said in the statement. 

If the CD-12 study results prove leronlimab is saving the lives of perilously ill Covid-19 patients, why wouldn’t CytoDyn disclose the data immediately? 

It’s standard biotech company practice to share the results with the public and investors right away when a trial is unblinded, even if it is holding simultaneous discussions with regulators. The outcome of the CD-12 study is also a material event for CytoDyn, so as a public company, it has an obligation to disclose expeditiously. 

Asked to further explain the company’s statement regarding its CD-12 results, Pourhassan responded via email, “Please clarify your question and your motive for asking such a question.” Pourhassan did not respond to a follow-up email on Wednesday. CytoDyn General Counsel Arian Colachis did not respond to a request for comment. 

Last July, CytoDyn issued a statement declaring leronlimab’s safety profile was “impressive”following the conclusion of a separate clinical trial involving patients with moderate Covid-19. Detailed safety data were not disclosed. 

Ten days later, CytoDyn organized a conference call for investors on which Pourhassan said the leronlimab study in moderate Covid-19 had delivered “positive efficacy results,” again without offering corroborating details.

Weeks and months later, CytoDyn acknowledged that the study failed to achieve its primary goal and that it was unable to provide definitive data showing leronlimab was effective against Covid-19. CytoDyn submitted the leronlimab data to the FDA anyway, requesting an emergency use authorization. The FDA denied the request. 

Last February, in the early days of the coronavirus’s global spread, CytoDyn announced the signing of a letter of intent to license leronlimab to a China-based health care company. One year later, CytoDyn hasn’t said publicly if the letter of intent ever led to a formal deal, or if any progress has been made.

In April, CytoDyn said it was “collaborating” with U.K. health officials to provide emergency access to leronlimab for severely ill patients with Covid-19. Emergency access has not been granted.

In May, CytoDyn said it was preparing a clinical trial to investigate the combination of leronlimab and Gilead Sciences’ remdesivir in patients with Covid-19. The study has not started. 

In May and June, CytoDyn said it had completed negotiations with the government health officials in Mexico to conduct a clinical trial of leronlimab in patients with Covid-19. This study has also not been conducted. 

In August, CytoDyn said it had requested “fast track approval” from U.K. regulators for the treatment of Covid-19 patients with leronlimab. No such approval has been granted. 

 

 

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Agree with everyone, that seems to be a pretty even handed take.

One thing we know he has definitely seen a lot of biotechs in trials.  If he thinks this behavior is weird, he is probably right on that one.

I'm struggling to understand it myself.  This situation is just so far out of the norm and the results are so fantastic that no one can talk about it?

Doesn't make sense.

Chet, do you think it makes any sense honestly?

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I'm having a hard time finding a reason for the stock to be rising right now.  I thought that we would slowly bleed down into the 3's after the PR on Monday morning.  

I don't think the paid article could be responsible for this uptick.  Someone I know suggested that it could be small leaks.  It seems if they are discussing results with a couple advisory boards, then there would be a much larger group that would be aware of the results.  The more people who are aware, the more likelyhood that information leaks out.

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26 minutes ago, Dwayne Hoover said:

Agree with everyone, that seems to be a pretty even handed take.

One thing we know he has definitely seen a lot of biotechs in trials.  If he thinks this behavior is weird, he is probably right on that one.

I'm struggling to understand it myself.  This situation is just so far out of the norm and the results are so fantastic that no one can talk about it?

Doesn't make sense.

Chet, do you think it makes any sense honestly?

His main goal is to erode the confidence of the longs.  That's it.  I don't think he'd ever write anything complimentary about CYDY. Don't base your decision in anyway on anything he's written.  He's the scum of the Earth and is trying to enrich his scummy friend Joe Spiegel from BuyersStrike!  Those two should rot in hell for their actions.

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7 minutes ago, chet said:

His main goal is to erode the confidence of the longs.  That's it.  I don't think he'd ever write anything complimentary about CYDY. Don't base your decision in anyway on anything he's written.  He's the scum of the Earth and is trying to enrich his scummy friend Joe Spiegel from BuyersStrike!  Those two should rot in hell for their actions.

We get that...but I think DW is asking?

Do you really believe NP is keeping quiet on statistically significant results?

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20 minutes ago, Chaz McNulty said:

I'm having a hard time finding a reason for the stock to be rising right now.  I thought that we would slowly bleed down into the 3's after the PR on Monday morning.  

I don't think the paid article could be responsible for this uptick.  Someone I know suggested that it could be small leaks.  It seems if they are discussing results with a couple advisory boards, then there would be a much larger group that would be aware of the results.  The more people who are aware, the more likelyhood that information leaks out.

Possibly. I still have a very hard time believing they just unblinded Monday though.

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Just now, Charlie Harper said:

We get that...but I think DW is asking?

Do you really believe NP is keeping quiet on statistically significant results?

I do.  I think he's in negotiations/discussions with the FDA and doesn't want to say anything that could jeopardize them.

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Just now, chet said:

I do.  I think he's in negotiations/discussions with the FDA and doesn't want to say anything that could jeopardize them.

Ok. So why would the FDA care? Why does it have to be kept under wraps?

I would imagine Biden would love to announce there's a "cure" for COVID and after seeing what's going on in GME, I don't doubt institutions would be gobbling up shares. 

I had don't understand the logic for NP or the FDA to keep this mum.

Not arguing. Just trying to think out loud and discuss.

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1 minute ago, Charlie Harper said:

Ok. So why would the FDA care? Why does it have to be kept under wraps?

I would imagine Biden would love to announce there's a "cure" for COVID and after seeing what's going on in GME, I don't doubt institutions would be gobbling up shares. 

I had don't understand the logic for NP or the FDA to keep this mum.

Not arguing. Just trying to think out loud and discuss.

NP has a horrible reputation with the regulators and the industry in general.  The FDA would care because they would be getting external pressure to approve before logistics (production, distribution, sharing with Canada and the UK) are finalized.  CYDY is a small company that struggles with easy tasks.  This approval will be unlike anything they've ever undertaken and NP and SK don't have the skill or experience to succeed without help. 

This is my best guess as to what's happening.

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14 minutes ago, chet said:

NP has a horrible reputation with the regulators and the industry in general.  The FDA would care because they would be getting external pressure to approve before logistics (production, distribution, sharing with Canada and the UK) are finalized.  CYDY is a small company that struggles with easy tasks.  This approval will be unlike anything they've ever undertaken and NP and SK don't have the skill or experience to succeed without help. 

This is my best guess as to what's happening.

That's the best take on this I've heard. Makes total sense. It also explains why NP would not be so eager to advertise what is happening.

Edited by Dave RL
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1 hour ago, chet said:

His main goal is to erode the confidence of the longs.  That's it.  I don't think he'd ever write anything complimentary about CYDY. Don't base your decision in anyway on anything he's written.  He's the scum of the Earth and is trying to enrich his scummy friend Joe Spiegel from BuyersStrike!  Those two should rot in hell for their actions.

I don't trust him, don't get me wrong.  He's proven he's not trustworthy.  Ive seen him lie outright.

This article didn't see as off to me but obviously we aren't seeing the whole picture behind the scenes. I also have not seen enough biotech trials to know if this is even somewhat normal

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8 minutes ago, Dwayne Hoover said:

I don't trust him, don't get me wrong.  He's proven he's not trustworthy.  Ive seen him lie outright.

This article didn't see as off to me but obviously we aren't seeing the whole picture behind the scenes. I also have not seen enough biotech trials to know if this is even somewhat normal

His articles come off as paid advertisements now.  They used to mean something, but now I view it the same way I would view a Seeking Alpha article.  I think AF has lost a lot of credibility.

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Sometimes having faith in this stock is akin to believing the Easter Bunny is going to come to visit in a month's time.

I don't think they hit their primary endpoint, I'll just leave it at that.  Doesn't mean game over but that's where the holdup is if you ask me. 

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From Ihub regarding endpoints.  FDA apparently changed guidelines 4 days ago...

Quote

FDA Changes EndPoint Guidelines for Severe/Critically Ill COVID Therapeutics/Biologics on Feb 22, 2021

I found this information interesting and possible explanation of why Cytodyn did not release TLD and why they are talking with the FDA. However, make your opinion on these findings.


FDA Guidelines (sources)

May 11, 2020 guidelines:
https://issuu.com/greeley2/docs/fda_guidancecovid_19-developing-drugs


Feb 22, 2021:
Press release: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-policies-guide-medical-product-developers-addressing-virus

Updated Guidelines: https://www.fda.gov/media/137926/download[/url][tag]insert-text-here

Comparison
Quote:
- In a trial in severe and/or critically ill patients, examples of
appropriate endpoints could be
- All-cause mortality at an appropriate time point
(e.g., at least 28 days for hospitalized noncritically ill
patients,(footnote27) 60 days for critically ill
patients(footnote 28)

- Footnote 28
"C Karagiannidis, C Mostert, C Hentschker, T Voshaar, J Malzahn, G Schillinger, J Klauber, U Janssens, G Marx,
S Weber-Carstens, S Kluge, M Pfeifer, L Grabenhenrich, T Welte, and R Busse, 2020, Case Characteristics,
Resource Use, and Outcomes of 10021 Patients with COVID-19 Admitted to 920 German Hospitals: an
Observational Study, Lancet Respir Med, 8(9):853–862."

(This study seemed to influence the change)

The FDA has changed the guidance for endpoints related to Critically Ill Covid Patience on All-Cause Mortality from 28 days (May 11,2020) to 60 days (Feb 22, 2021).

Is it a coincidence that Nader issues a press release the same day the FDA updated guidance? I think this was intentional.

With this new guidance the CYDY CD12 Trial is in a gray area. The trial is concluded with data at 14 days, 28 days and 42 days (reco from DSMC). However, the FDA is reco/asking for 60 days of data for Critically Ill. I doubt that the FDA revised this guidance on Feb 19th and probably was pulling this together over the past month, the same time CYDY was ready to report.

Either CYDY was aware of these changes in early FEB (after Nader said TLD was going to be reported) OR FDA contacted CYTO to let them know (less likely) or CYDY went to share the unblinded data with the FDA first and they realized they had an conflict between the data collected and the new guidelines being developed. Maybe the FDA needed some time to provide guidance to CYDY on how to manage the data from the trial and path for submission.

This quote (IMO) makes a little more sense now. “We are eager to reach conclusion in our discussions with all the regulatory agencies for the path going forward and will release the details of our data and the results of our discussions with regulatory agencies in the coming weeks.”

You make your own decision, but did not see anyone talking about this point.

 

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They could be looking at 42-day and 60-day data.  With ventilators and ECMO, many placebo patients could live to 28-days and then pass away a week or two later.  Makes sense to me. 

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20 minutes ago, chet said:

They could be looking at 42-day and 60-day data.  With ventilators and ECMO, many placebo patients could live to 28-days and then pass away a week or two later.  Makes sense to me. 

This makes the most sense but I have a dumb question.  The OLE basically moved all the placebo patients on to LL, correct?  When was that done?  Presumably prior to 60 days.  Wouldn't that make an analysis of 60 day endpoint impossible and necessitate a new study?  I hope I am wrong.

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