Cytodyn Inc (CYDY)

[Ambersavage7194]

I will not take NP word that it (R O testing) was NOT required or FDA only asked for it after some length of time

TheSwordMan,

I may not agree with all your opinions, and I'm unsure of how you came to the conclusion that FDA only asked for RO after moving the goal posts, but you are "mostly" correct. I understand roughly why it was needed and why it was always needed. This is something someone like Patterson would understand very well.

However, what I don't understand, is why the FDA would approve a trial without Receptor Occupancy in the first place. Typically RO tests would be listed under "Other Outcome Measures" on Trial design. It's evident that it was never incorporated into our Combo or Mono trials. They should never have been approved without ensuring binding of our drug, as that's our MOA for HIV. Its necessity requires that we ensure Leronlimab is in fact binding to CCR5, to exhibit the appropriate decrease in Viral Load.

So it's really a very odd situation were in. Why would FDA approve a trial without it, and why would they suddenly ask for it during or after our Mono trial, if they approved the trial without it. It's very strange and only a small group of people truly know the intricacies to the answers of those questions.

But yes, Nader does not understand the purpose or necessity of a RO test. It's not his area of expertise, but he should have surrounded himself with people who could guide him with that knowledge, and he has not. I will not speak ill of Recknor, as I think he potentially could be really great for our company. But it's evident, based on his answers from the last CC, that either he also doesn't understand the purpose for Receptor Occupancy test, or he's being pushed by Nader to take a shortcut and submit another BLA without the RO data. I'm unsure of which scenario it is, so I'll give Recknor is being pushed to do this, and assume/hope that he really does understand why RO is needed.