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Re: Investor2014 post# 319558

Sunday, 07/04/2021 8:57:15 PM

Sunday, July 04, 2021 8:57:15 PM

Post# of 462352
I agree with your timeline (as the worst case).

But I am hoping that they won't take as much time to do the data tabulation and crunching the second/third time. If they are meeting with the FDA before that, where the recent Rett trial is going to be discussed, they may get some guidance from the FDA that may help speed up the post trial process.

Would be happy if we can get approval by H1 2022 should trial data be good enough.

Going by the general assumption that the drug will be even more effective and telling in Pediatric patients (compared to adolescents), what are the odds that FDA will show some much needed concern and give its blessings for the kids first,(followed by an approval for adolescents based on the other pending trial) should the data be that good? (Knowing that there is already one data set - that recently came out - which shows enough promise).
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