Cytodyn Inc (CYDY)

[Saltz]

The current meeting with the FDA is to gain assurance that they are on the same page with locking the trial. Then they will crunch the data and meet a second time. BLA, BTD, AA cannot be discussed until they have the compilation of the data. The Combo PE data and Mono data will be used to submit both the efficacy and safety packages to the FDA. The outcome will have a profound impact on Pro-140.

Will we be dashing ahead with BTD, AA, and a clear pathway for gaining BLA approval?

Or will the results of Combo PE be lackluster and non conclusive and the FDA asking for a broader based P3 trial.

I strongly doubt the later. Chances are good that we can get it all. The result also may fall somewhat in between like you met Combo PE and let's discuss BLA but no on BTD and AA. The results will need to be convincing on the Combo PE to get it all. The safety part of the package should be a slam dunk at that point because there have been zero SA's or safety issues with over 200 patients. This is important because safety is where they put the hammer down. The FDA approves many drugs that may not be significantly efficacious but they are very stringent when it comes to safety. That is another reason why I am so bullish on Pro-140. Its all there.