FDA has nothing to do with "release" of the CD15 L
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Posted On: 12/02/2021 3:46:18 PM
FDA has nothing to do with "release" of the CD15 LH trial results. That process is just CYDY investigators and collaborators writing up the results in journal form, and submitting it for publication. No FDA involvement whatsoever.
Regarding the delayed start for new LH trial, that is both CYDY and the FDA involved. CYDY probably had some informal back and forth with FDA on appropriate endpoints for the trial. CYDY did not formally submit the proposed trial protocol for the PIIb/PIII LH trial until recently, I don't believe (though can't find the details where they were talking about filing / submitting the protocol).
Hopefully we are able to come up with some good LH endpoints, not an easy thing to do. I'd rather get it right and make sure FDA is on board than to pick a difficult endpoint (like mortality for acute Covid) unlikely to hit.
Regarding the delayed start for new LH trial, that is both CYDY and the FDA involved. CYDY probably had some informal back and forth with FDA on appropriate endpoints for the trial. CYDY did not formally submit the proposed trial protocol for the PIIb/PIII LH trial until recently, I don't believe (though can't find the details where they were talking about filing / submitting the protocol).
Hopefully we are able to come up with some good LH endpoints, not an easy thing to do. I'd rather get it right and make sure FDA is on board than to pick a difficult endpoint (like mortality for acute Covid) unlikely to hit.
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