As you know--and I explained--the "straw that brok
Post# of 154993
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Posted On: 06/29/2021 2:34:26 PM
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As you know--and I explained--the "straw that broke" for me was the last CC when we heard "file format" as another excuse for BLA failure. This might be true--but is 100% in conflict with "Amarex is doing fantastic job"--for several years.
To infer that they are excuses rather than what actually went down and the FDA isn't the primary bad actor is false. The FDA was the one who chose the 700mg dose knowing full well that RO was not part of the protocol and that maraviroc was approved without RO, yet Cytodyn had to justify a dosage they chose.
But yes Amarex does suck.
The first thing that the FDA asked for was additional 700mg safety data from the mono trial. Then they asked for 700mg stability data. That was done by January 2020. Whereupon the FDA asked for additional data from the mono trial, unspecified but it seems like RO data (which was unnecessary). Then they asked for additional data through the end of the mono trial, also unspecified but most likely RO data. It seems their wasn't sufficient RO data so an RTF was sent.
Dr. Rahman was hired to sort it out. How he formatted what data we had or set up the justification is unknown. Then the FDA didn't like the formatting.
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