What is also possibly interesting is cytodyn’s strategy. It is looking like, in my opinion, that when the unblinding occurred and they gave the FDA the raw data, the FDA went right to the P value for the primary endpoint. I am sure the discussions were over all the data and all the endpoints and Cytodyn asking is this good enough of a trial to support the obvious benefit of leronlimab. I don’t see how leronlimabs efficacy can be doubted, the only problem is the flawed trial. The FDA I am guessing stuck to the P value and cytodyn released the data in its typical cryptic way to the public. Cytodyn knows no matter how the pr is written, the shorts will spin it negative. However, the doctors and intelligent public will see clearly the situation. This is a negotiating tactic in discussions with the FDA, now they have many begging and demanding this drug and putting blood on the hands of the FDA for every day they don’t give an EUA. There is plenty of data in this trial to support the drug, and the FDA know it.

The FDA would really prefer things go the way that they want , but the public is putting them in the hot seat. If they require the extension trial and the trial confirms what we already know, then they wasted lives to create a trial they like. If a foreign agency approves leronlimab and recovery of severe/critical patients becomes the top story, the FDA is in the hot seat. It is not difficult to see a huge problem is brewing for the FDA if they don’t do the right thing. A congressional investigation is very real.

As much as it looks like cytodyn painted themselves in a corner, in reality the FDA is the one painted in the corner.