The FDA is not judging the safety of Leronlimab, they are judging the Company, not their job, and judging our "Housewives" CC's. Or what I would say is that they are really doing is using the PERCEPTION of the ineffectiveness of CYDY to keep Leronlimab off the market.
Because as far as safety is concerned, CytoDyn has been quite effective in proving it. Forget the 8 years of HIV work under the FDA, lets look at CD10, CD12, Long Haulers, mTNBC, and NASH. Each trial had a Data and Safety Monitoring Committee (DSMC) and support staff that operates independently of the CRO and PRMC. Each DSMC approved the safety of Leronlimab. It's their experts saying it's safe (and to use only two doses.) That takes CYDY and Amarex out of the safety question.
So to cover their ass for watching reruns of our "Housewives CC's" the FDA had an HIV Powwow with outside experts to show us how to do it right by having us do an HIV trial protocol, (WTF since we weren't pursing that indication), and by my estimation it was submitted Oct 18 and will be lifted before Thanksgiving.
BTW, Craig just wants to say that the company is ineffective so he can buy back that half of his holding he sold hoping the SP would go down.