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crescentmotor

04/18/24 8:27 PM

#457041 RE: skitahoe #457033

the way I'd show what I had is by applying for approval to the regulators. I believe that even in RETT's they have sufficient data to take a shot



My opinion is that AVXL will certainly not proceed with an NDA for Rett approval based on a technical trial failure to meet endpoints without the FDA's encouragement. By the way, has AVXL even requested a meeting with regulators to discuss the EXCELLENCE results? Nearly four months have passed since the top line data was released. Will we see full data by mid-year 2024? It could easily be late 2024, or later, before shareholders see any additional clarity about any path forward in Rett Syndrome.