My impression from the proactive interview is that

My impression from the proactive interview is that the added data for cd12 is to fill in holes from the original endpoint to make the trial significant. I am also assuming the fda has already strongly told cytodyn this is not going to be enough. The trials in India and Brazil must be a direct work around the us fda. Dr Jay’s letter to the fda must have been cleared with cytodyn, and as much as Nader reinforces a positive relationship with the FDA, the open letter is doing the heavy lifting to tell the FDA that this lack of an EUA is BS in an un-official way.