Cytodyn Inc (CYDY)

[fred198484]

As stated several times the Combo Trial PE Data is being used to create a pathway for Mono with the FDA. The FDA all but told CYDY to supply PE Data for Combo and additional safety data from the Mono Trial and if results are strong we will consider Pro-140 as a Mono therapy.

What is your source for this claim? It certainly does not sound like the way the FDA usually works. Are you just drawing inferences based on what you have seen or has someone who has more knowledge of these things suggested this is the situation? Clearly, the FDA is already considering PRO 140 as a mono therapy since a phase III test is underway. And it is hard to see them accepting combo data to approve mono. Is that what you are suggesting?

I can see where the FDA might consider the combo PE data in conjunction with the mono safety data to grant the BTD and perhaps lay out a clearer path to approval than we have now.