Cytodyn Inc (CYDY)

[BlackDoggie]

I agree with all of this, though I'd unfortunately be quite surprised with a GvHD enrollment PR. Those in my circle know I've long been high on GvHD's potential as a catalyst, but management seemed to make it clear on the September conference call that it was on the back burner for the moment. Perhaps I misunderstood Pourhassan's comments, or perhaps the relevance of his comments has passed.

I have a suspicion that the FDA has, ahem, "encouraged" them to pursue HIV first. Otherwise, outside looking in, my money would have been spent on pushing GvHD as hard and fast as possible. The preclinical research is mind blowing. The IDMC agreed to make it open label after only 10 patients in a double blind format. The safety data is already there from the HIV trials. If the clinical data is at all reflective of the preclinical data, the FDA should be begging for a BLA for an accelerated approval pathway. This could then be used as a platform for label expansion for HIV instead of vice versa. The fact that this hasn't seemed to be the plan tells me I'm either missing something, or the FDA is helping to guide some decisions there. Not mutually exclusive by any means.

I can imagine other reasons for pursuing HIV first, and obviously the cancer trials need to be started ASAP, but I really hope/wish they'll push GvHD concurrently. An additional 10 patients seems like a small price to pay to see - and show the world - what they might have there.