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.