Cytodyn Inc (CYDY)

[ohm20]

Why the hell does the FDA need all mono trial data for combo BLA? From a trial that isn’t even done? I’m so confused by this delay and the reason given for it.

In the previous conference call when Nader said they wanted all monotherapy trial data I outlined it. It isn't because the FDA wants to know the MOA, the FDA has known that for a decade. Since the combo trial involves another drug all of the data would be irrelevant to leronlimab in monotherapy. The only reason it would be requested is that the FDA is looking at a label extension for monotherapy. T

he FDA should have asked for a protocol modification to the interventional study for the CCR5 occupancy test and used that data as a basis to file a BLA for monotherapy. It looks like they may want to make amends for the error of their ways. The FDA wouldn't do a label extension out of the kindness of their hearts. They would reconsider because of a backlash from the HIV community for withholding a safer treatment.