Cytodyn Inc (CYDY)

[bobshmob]

"2. Do you really, actually, had-to-bet-all-your-CYDY-stock think that the President's FDA/medical advisors/appointees would downplay or minimize Leronlimab's success because we are not in the big pharma 'club?' "

Absolutely. It's not that they say, "CYDY is not a member of the club, so let's minimize its success." Instead, as scientists, they are trained to be skeptical and ask questions. The game is one of eliminating doubt. When big pharma approaches the feds with results, they can afford to have put together an impressive data set wrapped in an equally impressive presentation. A long history of proven work in the past combined with long-held working relationships with FDA give their work a natural benefit of the doubt in evaluation.

CYDY? No way. They get the detriment of the doubt. A smaller study with bungled endpoint definition and less impressive presentation coupled with a CYDY management team that habitually generates doubts (about virtually everything) translates into great difficulty in removing doubts and getting approvals. This is an inherent problem in virtually any small pharma company, perhaps especially so with CYDY because of their hype-machine that always seems to be in overdrive.

The EUA standards are essentially: 1) demonstrated safety, and 2) reasonable expectation of efficacy. Leronlimab easily meets these standards but will have a tough time with the judges who will ask so, so many questions but want big pharma answers that CYDY can't provide without many more months of work.

Trump is aware of this phenomenon and tweeted about it the other day:

The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!

He's frustrated with a sluggish FDA. That's a good start, but then, as is typical, he loses the thread very fast, making lightning quick and goofy conclusions, namely, that FDA is sluggish because they want him to lose and that convalescent plasma is a "major therapeutic breakthrough." If he had a longer attention span, he might be able to see clearly through fog, but the FDA by itself is entirely incapable of doing so.