Replies to post #203627 on Cytodyn Inc (CYDY)

[Grip it and Sip It]

Have you not seen the email Nader sent their CEO demanding be file the BLA “even if it’s short” because the stock was down 20% and iHubbers were blasting him? It’s a great read. Not only was Nader dumb enough to put it writing, he linked his reason to the stock price then sold $15m on that insider knowledge. But yeah, let’s go with”Amarex bad” instead of years of Nader’s proclamations of “Amarex do fantastic job!” If the Pestell lawsuit or shareholder lawsuits for unjust enrichment are any indication, coupled with Nader’s termination with no backup CEO are any indication, I’ll go with Amarex for the win on this one!

[HyGro]

CYDY has very significant restrictions in reconstructing their clinical trial data. There are very specific regulations on the gathering, communicating, processing, auditing of clinical trial data:

"These electronic records have to comply with a Code of Federal Regulations (CFR), 21 CFR Part 11. This regulation is applicable to records in electronic format that are created, modified, maintained, archived, retrieved, or transmitted. This demands the use of validated systems to ensure accuracy, reliability, and consistency of data with the use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records."

CYDY trying to reconstruct the clinical data held by Amarex would not meet the requirements of 21 CFR Part 11 and therefore would not be acceptable for filing with the FDA.