Cytodyn Inc (CYDY)

[BlackDoggie]

If I'm hearing fred's argument right, he's saying that the need or desire to PR a meeting with the FDA post-P3 trial could only be driven by lawyers insisting that a company do so, and therefore must be a red flag.

I think that argument is insane. That doesn't mean I'm happy to see protocol changes, but come on. The company has always said it would meet with the FDA to discuss BLA after the P3 completes. A PR that they're following through with their plan must be driven by lawyers? From the 4/18 call (bold type mine):

Yi Chen

Thank you. So as of right now, the projection is still that the BLA for PRO 140 as a combination therapy should be submitted by the end of this quarter. Is that correct?

Anthony Caracciolo

That’s correct. I believe that’s still our goal. Now, I think what’s important to mention is that although we have had several very positive meetings and discussions with the FDA, we have not met with them to discuss our regulatory pathway for submission of the BLA. I think that’s still in front of us. And once we have all of the data compiled from the combination trial, our plan is to then to sit specifically with the FDA for a pre-BLA meeting and discuss with them the details of our application which will consist of three significant parts, the clinical, the non-clinical and the CMC section that Mike referred to.

Link to the transcript: https://seekingalpha.com/article/4063244-cytodyns-cydy-ceo-nader-pourhassan-hosts-investment-community-conference-call-transcript?part=single

So seriously, if you think that the a) getting a meeting on the calendar with the FDA that the company announced back in April was part of the game plan, and; b) lawyers forced the company to PR said meeting with the FDA are RED FLAGS!... then you're so completely off base that no amount of reasonable discourse can help you. Again fred, I think you're stretching very hard to find the negatives. And here I'll repeat, the changes to the protocol don't make me all warm and fuzzy. But the meeting with the FDA? Always part of the plan.