Replies to post #170963 on Cytodyn Inc (CYDY)

[Ambersavage7194]

Yeah it's a huge mess between Patterson and Cytodyn with faults on both sides. But point is, we needed the RO data from the Mono trial and Bruce withheld data we needed for our application. So then FDA asks for "mock datasets" which we can't produce without banked patient samples which we don't have. It's possible FDA may require more than only last 1/3 of Mono trial RO data, but that is majority of the patients who were on 700mg, not the 525mg patients. So it's also possible that it would have been sufficient for submitting our BLA

[Northstar42]

Hopefully, the true RO story will soon be known.