So a few things, in the second PR. "The first Pha
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Posted On: 03/27/2020 7:46:22 AM
So a few things, in the second PR. "The first Phase 2 clinical trial that was filed on March 26 is a randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of leronlimab in patients with mild to moderate documented COVID-19 illness and calls for 75 planned patients in up to 10 centers in the United States. Patients enrolled in the trial are expected to have a treatment window of approximately 6 weeks."
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.”
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.”
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