Cytodyn Inc (CYDY)

[HyGro]

Why would ANVISA approving a trial is by no means an endorsement of the drug -- it means they see the drug will not be a risk for patients. That not an efficacy endorsement.

If you look at the CD12 8K it clearly shows the manipulation of the statistics when the adjusted p-values for age. That was how the subgroup analysis was claimed to be statistically significant when it wasn't.

FDA statement reprimanded the company misrepresenting and manipulating the CoV clinical trial data:

Misrepresenting -- claiming the company met trial endpoints when they didn't - CD10 NEWS endpoint

Manipulating -- using inappropriate statistical models to claim statistical significance when it wasn't (also manipulation).

Read the FDA Statement: https://www.fda.gov/drugs/drug-safety-and-availability/statement-leronlimab

You can deny the FDA Statement and Letter, but they are fully documented by the press releases and the 8K data that NP filed. FDA saw the data and told NP don't bother filing as they saw the misrepresentations and manipulations. You can deny it all you want, but FDA is the law, and LL "fought the law and the law won." FDA handed the evidence to the SEC and the DOJ and now they are investigating NP and the company.