Replies to post #213899 on Cytodyn Inc (CYDY)

[Rubraquercus]

It is going to take monumental amounts of time and money to undo what nada did with shoddy sloppy half baked FDA communication.

The holds remain in place.

<<On March 31, 2022, the Company announced that the FDA had placed a full clinical hold on its COVID-19 program and a partial clinical hold on its HIV program in the United States. Under each of these clinical holds, no new clinical studies may be initiated until the clinical hold is resolved. The partial clinical hold on the HIV program allowed patients who were enrolled in the extension trials to transition to other available therapeutics. Under the full clinical hold on the COVID-19 program, no new clinical studies may be initiated until the clinical hold is resolved. The Company previously notified the FDA that it was pausing its COVID-19 trials in Brazil. We voluntarily withdrew the Investigational New Drug Application (“IND”) for COVID-19 in the United States. >>