for the sake of conversation, I am trying to look at these events to see if there is a different perspective. I was 100% agreement about the FDA until we learned about Amarex's screw ups. It is possible the FDA was getting pissed off that they were being blamed for the lack of getting behind leronlimab, but it could be they were tired of Amarex being so incompetent they could not look the other way. The BLA for HIV clearly shows the FDA trying to explain the Amarex what needs to be fixed and Amarex repeatedly failing to do the fixes. The protocol for CD12 could have been poorly designed by Amarex and the FDA assumed they know what they are doing. They then got blamed when they did not give an EUA for a statistically deficient data when it was from trial design submitted to them. I'm sure whoever wrote the FDA letter was angry that Cytodyn was not publicly exposing Amarex as the problem. The FDA just needs enough to back up there approvals - they may look the other way for BP but they stick to the book normally.

Also, The fda had 5 directors under the last administration and does not actually have one now. Anyone ever worked for a company without a president or CEO? the hierarchy of the FDA is likely more concerned about the internal politics of keeping their jobs and not sticking their necks out on anything. I'm surprised anything is getting done but the FDA. It is pathetic how dysfunctional the FDA is despite they very structured process. if there is ever a need for a functioning FDA, it is during a pandemic and they are the less functional than ever. going world wide with leronlimab was incredibly smart of cytodyn, i think it is motivating the FDA to get back on track in regards to leronlimab.