So a few things, in the second PR. "The first Pha
Post# of 148177
The first one was filed Mar 8, also, noted, and that seems FDA wants a modification and then requested a second randomized study to cover the severe patients. So that covers, mild to moderate and now severe so we do not have to file emergency IND for every severe patient.
This is really great news seems all bases cover now for the trial but can't figure out why a randomized study is included in the severe cases must less the mild to moderate.
"Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, “On behalf of all COVID-19 patients, we are thankful for the FDA’s responsiveness and their ability to provide timely guidance in order to collaboratively finalize our Phase 2 trial protocols. We will now also immediately file a second trial protocol, per the FDA’s suggestion, for severely ill COVID-19 patients.”