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blu_1

02/11/22 11:38 AM

#350813 RE: LakeshoreLeo1953 #350769

Of course they didn't outright say that; however, I bet their talks centered around what it would take to get 2-73 approved. Did FDA come right and say that? Of course not, but that was the unspoken point of the discussions. Huge unmet need for Rett. We're just talking bout getting approval for adults only in short term. Bar is set super low. Most importantly, the drug appears to be tolerated well. Why did Anavex bother to change trial to Ph3 if not to seek approval now? We all know why they did it ;) Missling said they're very close to bringing it home for Rett.
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FitzyP33

02/11/22 5:00 PM

#350856 RE: LakeshoreLeo1953 #350769

We have no idea about FDA guidance because Missling won't tell us any details.