That the FDA wants receptor occupancy is BS on the
Post# of 153887
(Total Views: 571)
Posted On: 04/21/2021 10:29:33 PM
That the FDA wants receptor occupancy is BS on their part. The FDA approved the protocol for the combo trial as a pivotal trial at 350mg. Cytodyn achieved statistical significance on the endpoint with flying colors. That is the basis upon which the FDA should have judged the trial.
That they want to come back and see results including receptor occupancy because of better results from a higher dosage in the monotherapy trial is irrelevant. They should have accepted a BLA on the combo trial as it stood. Then asked the company if they could do a second combo trial on the higher dose or just asked them to submit a protocol for a higher dose on a pivotal monotherapy trial.
That they want to come back and see results including receptor occupancy because of better results from a higher dosage in the monotherapy trial is irrelevant. They should have accepted a BLA on the combo trial as it stood. Then asked the company if they could do a second combo trial on the higher dose or just asked them to submit a protocol for a higher dose on a pivotal monotherapy trial.
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