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Alias Born 04/30/2005

Re: None

Monday, 11/20/2023 6:32:01 PM

Monday, November 20, 2023 6:32:01 PM

Post# of 461409
It's my understanding that once you submit your New Drug Application (NDA) to the FDA for approval, they will respond within 30 - 60 days as to whether or not they will accept the application.

If they find something wrong, they will send you a rejection letter and explain why they rejected your NDA...which could vary from a minor correction to a complete failure.

On the other hand, if everything is in order they will acknowledge your NDA within the 30 - 60 day period and the procedural evaluation and approval process begins.

So, I'm wondering if the TGD has already submitted the NDA for Rett syndrome; and is now waiting the 30 - 60 days to confirm that the FDA has accepted our New Drug Application?

Now that would be a great surprise to everyone, no?
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