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CytoDyn Inc CYDY
(Total Views: 728)
Posted On: 02/13/2022 12:44:28 AM
Post# of 154138
Posted By: ohm20
Re: CTMedic #118011
Quote:
Yes, FDA denied a four dose trial regimen, but CD12 was an adaptive trial which was not well executed (unequal distribution between placebo and leronlimab arms) and for which planned interim analyses were skipped.



I would still like to know how that population skew occurred. As far as the 75% interim that analysis would have occurred with a full trial and very near the end of it. We're not Gilead there is no way the FDA would allow us to change the endpoint at trial end. Changing number of doses would have been futile and the FDA wouldn't have allowed it anyway. The skew was bad but the overwhelming determinate of trial failure was allowing only 2 doses.













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