Replies to post #200741 on Cytodyn Inc (CYDY)

[ClosetInvestor]

“I guess in the end all that needs to happen to get the DOJ and others off of Cytodyn's back is to verify trial results.”

If the investigation were only that simple.

HIV was added to the investigation list in the most recent 10q. Why? Well, we have a good idea. The lawsuit against Amarex revealed three things: 1. The email from NP to Amarex appears to show he knew the BLA was incomplete; 2. The Amarex CEO stated the company had told NP multiple times the BLA was incomplete: and 3, per the RTF, the BLA was grossly incomplete.

SEC filings show that NP and SK sold approx $20 million worth of shares in the days following the filing of the BLA, which may be insider trading if the DOJ can prove NP/SK were aware of the discrepancies in the BLA when it was filed.

So, simply showing efficacy of leronlimab will not be enough.

[HyGro]

The company provided the FDA with all of the CD10 and CD12 data. The FDA saw all of the company's claims and the actual data and came to a different conclusion. From the FDA Statement still posted on the FDA website"

"With the conclusion of both the CD10 and CD12 clinical trials, it has become clear that the data currently available do not support the clinical benefit of leronlimab for the treatment of COVID-19. In the smaller study that CytoDyn conducted in patients with mild-to-moderate COVID-19 disease (CD10), there was no observed effect of the drug on the study’s primary endpoint or on any of the secondary endpoints."

"the data from CD12 illustrated imbalances in mortality among subgroups, some favoring leronlimab and some favoring placebo. None of these analyses met statistical significance when using established and reliable analytical methods that correct for multiple comparisons."

Dr. Jay is wrong. Even NP has admitted in both cc and press releases that LL failed to meet ANY of the primary or secondary endpoints. The post-hoc data dredged subgroup analyses were also not statistically significant and the company had manipulated the p-value computations to make them look like they were. FDA reported this to the SEC and DOJ as false and misleading data reporting and this initiated the investigations. They have since expanded their investigation to include HIV and mTNBC data communications too.