Replies to post #212124 on Cytodyn Inc (CYDY)

[The Dark KnaDDir]

Why has this company refused to release the full HIV data set for peer review? No unbiased outside eyes have seen the data. Wouldn't such ground breaking work be published in a journal by now? All you have is the word of Nader Pourhassan saying the trial was a success. By the way, do you think Amarex collected the HIV data properly? Or were they incompetent here like they allegedly were in other trials?

[kgromax]

But now with medicine , this is something I understand a little , so I will like to explain again what happened with leronlimab in the last few years with HIV and Covid..
--- With HIV , our combo study for MDR patients , with 350 mg had excellent results , 81% efficacy , and not one serious side effect..

But now with statistics, this is something I understand (that's my profession). The numbers you quote are "fake" for statisticians, because they have not been corrected for the data dredging performed by Cytodyn. Nader himself recognized it in the Q&A session of the CD12 conf. call (there was a direct question on that).

I could very easily produce such seemingly good numbers with saline if you give me enough placebo data to slice and dice (i.e., cross many variables, age, criticity, ventilator/no ventilator, first/second injection, race, ...). This the classical trap of data dredging: you can always find "anomalies" if you slice and dice enough the data. Statistical techniques are specifically designed to counter data dredging. However for these numbers, these techniques have NOT been applied by Cytodyn. This is, statistically, a fraud.

Statisticians or biotech analysts can identify these issues. That's why Cytodyn could never convince any of them, and targets instead naive retail investors.

[ClosetInvestor]

“But now with medicine , this is something I understand a little , so I will like to explain again what happened with leronlimab in the last few years with HIV and Covid.”

Question: why hasn’t the combo trial data ever been peer reviewed and published?

[Easka]

Excellent post Misiu.

[theswordman]

I always like when there is ref to Dr J Lalezare. Perhaps the answer to your question can be found in his quote:

So for the rest of this presentation, 1 of the things I'd like you to understand is that whatever data I'm about to show you , is data that actually has been generated using what is likely to be sub optimal dosing of the drug based on the IC 50's. Not only suboptimal dosing but suboptimally delivered--suboptimally dosed for duration. That's an observation that has been completely ignored by CYTODYN


And how can this happen--how can this be true?? Lets once again turn to Dr Lalezare for the very answer:


This is the most INEPT COMPANY I've ever dealt with. I've been an investigator on around 300 studies , probably 50 companies. And THEY hands down win the prize as the most ineffectual GROUP ever.
Their CEO ,he's got no medical training, no training in drug development. He's a terrible communicator and most importantly, he doesn't listen.

[TheProfesser]

Great post! You know it’s good when it garners so much attention from the crew.

[Emergcy]

Thank you. Great summary.

[HyGro]

One problem, Nobody has vetted LL's 81% for HIV MR2+ (i has only been a press release and a poster). This 81% is only among MR2+ patients that are CCR5 tropic and screened. Gilead's capsid inhibitor was 83-95% effective (depending on ART combination), only requires TWO doses a year to LL's 52. Gilead had similar safety profile as placebo. It also has a daily oral dosing option too. It is also useable for ALL MR2+ patients, not just CCR5 tropic.

LL has lost years trying to get a BLA prepared and them filed an incomplete BLA. Now the company is way behind again having just gotten their data back to start the process. The RTF is 20 pages long so they is a lot more just OR testing. All this while they are running out of cash.

LL's S/C CoV data dredging came up with the 82% but the sample was so small that it was NOT significant. Read the FDA Statement - NP manipulated the p-values for the trial. Now Brazil trial is stopped and company has no cash to pay for the trial. As current CoV variants are not as dangerous, the S/C treatment needs are much smaller then before. Unlikely FDA is going to vet any CYDY CoV trial from Brazil. CYDY didn't do a IND for the trial or have FDA audit the trial. NP claimed the trial was only for Brazil approval. Ignored U.S. requirements.

[JPG77]

Great post, Misiu! I stickied your post!