Gestalt, I have been pondering over your thoughts for months, to myself, that Cytodyn, the sponsor, should draw up the protocol for them selves after all, the company is paying for the trial, millions of dollars, right? When I pay for something & "I" want to do it a certain way, "I" should have say in how I want something set up. But I will ask an expert for his opinion b4 I start construction or what ever. Here, Cytodyn wanted 4 doses and, maybe I'm wrong but if the doctors and scientists or the consulting advisory board members thought 4 doses would be better than 2 doses in light of the half life of Leronlimab, they should have been able to have their say and do it in accord to what those doc's, and the advisory board experts think the protocol should be set up, no?

Gestalts quote:

I would like to understand better how he protocol is developed and how much the sponsor and the FDA can form it. It looks like the sponsor creates the protocol and the FDA gives feedback on the changes they want. I can see this working fine, however what happens when the sponsor knows it is a flawed protocol and the FDA stands there ground? I feel like there was a point at which Cytodyn had to decide to either do the trial the way the FDA wants and risk a failure or not do the trial at all.

I get that the FDA is the entity that is putting their stamp of approval on it in the end, but the sponsor is paying for it, knows their product and has everything to loose with a failure. It would be great if the formal back and forth was made public. We are asking too much to expect any politician or media to look beyond the primary endpoint.