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mike_dotcom

03/01/23 2:58 PM

#405384 RE: BAR123 #405383

Good question.
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Investor2014

03/01/23 3:00 PM

#405385 RE: BAR123 #405383

I would imagine that, unlike Anavex, RETA filed something for the FDA to look at.

we just keep getting no love from the FDA.


That's how this stuff works you know.
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Anshu2

03/01/23 3:00 PM

#405386 RE: BAR123 #405383

haha. Foremost, because AVXL hasn't even filed an NDA. :)
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abew4me

03/01/23 3:03 PM

#405387 RE: BAR123 #405383

You have to file an NDA to get approval from the FDA.

Anavex has chosen not to file for the adult rett trials...and instead decided to wait for the pediatric Excellence trial to finish before filing.

Having a full adult+pediatric filing probably increases the approval odds...as well as an easier reception to receiving the valuable voucher.