Cytodyn Inc (CYDY)

[RTBhub]

Hi Misiu - (and also replying to JPG) -
"Fraud" is a strong word to apply to the HIV trial. I prefer to say that that trial is/was "fatally flawed" in some way. I don't think LL is "approvable" based on that trial, and I have strong doubts that the BLA will ever be submitted. I mean, really, it has been about 4 years and they are still citing a data conversion issue? Of course, I don't know the specific problems, but I think they stem from the small number in the trial and the "blending" of other trials and doses to document the safety. Just too "non-traditional" and complicated to get the approval.
My "proof" is quite simply the fact that they haven't been successful yet after four years. They could have spent a full two weeks on every single patient's data in this time to make it perfect. This has been going on for a lot longer than the pandemic. For all the hand-wringing about "saving lives," they could have helped themselves simply by getting this data organized. Since they didn't/haven't, I have concluded that it likely isn't possible.
I do not doubt that LL works really well for some people. I do doubt that the team knows exactly why or how. My "proof" is their inability to design a trial of sufficient size and rigor to definitively hit p-values with the entire population.
But, in summary, yes, I agree with the original poster that the HIV trial will not yield an approval, and perhaps not even a submission.