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Re: end2war post# 346922

Thursday, 01/27/2022 6:15:02 PM

Thursday, January 27, 2022 6:15:02 PM

Post# of 459599
There is another possibility that should be added to the list.

Avatar is eligible for a rolling review submission. That means sections of the NDA can be submitted before the entire NDA package is completed.

Here's the interesting part. Much of the NDA for pediatric Rett will be the same as for the Adult Rett. The sections on GMP, drug MFG inspection, safety history etc. will be identical or pretty similar.

So Anavex can get many of the sections of the NDA for Adult in process and approved without filing a complete NDA thus making sure that an Adult approval won't negate the voucher by coming first. It can then use most of the approved sections to speed a full NDA for the pediatric Rett through the approval process.

Interesting possibilities.

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