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.