Cytodyn Inc (CYDY)

[gestalt2]

I have to be honest, i was hoping for more details about where we are at with mono enrollment and what the details of how this # of patents required for both combo and safety came about. Nader left me with the impression that the FDA wanted 50 patients for "clinical relevance" and "statistical power" and that we are really just going along with it as if that was always the plan. Both of these reasons seem to indicate that they want bullet proof data and that the protocol is really just a guess as to what will be ultimately required. I guess when experts say there is no guessing what the FDA will want that means this very scenario we are going through. I hope there are not these types of surprises in the future but i have to wonder if the 24 week data might again raise questions about the details of the trial protocol. My hope is also that because we are so close to putting out real current data that the story about pro 140 is greatly de-risked and the significance of the FDA changes is far less of an issue in comparison to the almost certainty that pro 140 is what they say it is.