Cytodyn Inc (CYDY)

[BlackDoggie]

Edit: I see that I should have read ahead, and I would know that misiu already responded... I'll leave my post anyway.

They don't technically need FDA approval to unblind the data from the first 30 patients - but they may need FDA agreement to include the additional patients they've enrolled. I believe they're having discussions with the FDA to ensure that they're all on the same page with unblinding the data and including (or not) the additional patients to avoid any costly procedural missteps. I believe they'll have the data in hand long before the meeting in October, as my understanding is that meeting is intended to discuss BTD and a BLA, which would both require having the data in hand to discuss.

All of that is my speculation, except for the bit about not needing FDA approval to unblind the 30 patients that were agreed upon in the original protocol.

Misiu or any others with deep experience, please feel free to chime in if I missed anything here.