There is some question about this. CYDY was already operating and eIND trial for LL Cov for critical patients with four doses -- FDA approved it. But somehow CYDY claims that FDA wouldn't approve it for the actual CD12 trial. Questionable.
FDA has very clear Statistical Guidance documents are the methods that are accepted for approvals. Cytodyn manipulated statistics using "adjustments" for their p-values. Sorry no biotech is allowed to do that. But NP did so he could claim statistical significance when it wasn't really -- thus the FDA Statement, SEC and DOJ investigations.
The manipulations were document in the 8K which CYDY filed with the SEC which is now part of the SEC investigation along with press releases, YouTubes, Proactives, etc. when NP repeatedly made false and misleading claims. Again, that is why SEC and DOJ investigation, FDA Statement and Letter.
Cytodyn can try to challenge the FDA's statistical analysis, but FDA statisticians have seen all the statistical manipulations and know the guidelines. Ain't going to change the situation -- it is a done deal.
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