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Tuesday, September 12, 2023 12:52:17 PM
the FDA always prefers co-primary endpoints unless there is a bio-marker
The Anavex Rett is a P2/3 trial and was written more like a P2 than a P3 in that the "outcome measures" are as such, RSBQ is primary and within a long list of extremely important secondary outcome measures is CGI-I.
First your comment is pure speculation and second, I believe the anchoring concept is up for debate and has been the subject of academic discussion.
The single RSBQ endpoint anchored on CGI-I is not going to be accepted by the FDA as p3.
It is unfortunate biomarker development for a rare diseases aren't really a priority, it could have made the Rett trial design less subject to trial design arguements.
Also, within the secondary list are measures that may become biomarkers .
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