Agree 100%.
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Quote from boi:
If that report is true, it is very encouraging.
If the FDA instead came to Anavex and said, "Hey, you know that 2b/3 trial you are conducting for Rett? How about turning it into a pivotal Phase 3?" that would give an entirely different spin on our expectations after endpoints are hit. We wouldn't have to be concerned very much with the n, because the FDA would have known about that before approaching Missling, or the novel hybrid primary endpoint arrived at after consultation with the soliciting agency. Timing concerns also vanish. (Corporate communication issues remain.)
There's a hint on a Stocktwits post about why the FDA may have made this reported move, and I Googled this one to confirm the post. There's a June 2020 article in the Pediatric Neurology journal (the abstract is available online) that concludes the RSBQ "did not achieve acceptable standards as an outcome assessment for clinical trials in Rett Syndrome."
Acadia's LAVENDER study reported in December 2021, using the RSBQ and CGI-I as endpoints. The FDA may have had issues with the RSBQ endpoint in light of the scholarship -- this is obviously speculative -- and was looking for a more reliable alternative in AVATAR's novel primary endpoint(s), which has apparently been suggested in an NIH paper. If these dots connect, things will look very good for an NDA green light for adult Rett via AVATAR.
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