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Re: Kb1123 post# 432720

Monday, 09/25/2023 5:52:57 PM

Monday, September 25, 2023 5:52:57 PM

Post# of 463809
FDA timelines....
File an NDA. 2 months for the FDA to decide to accept it.
Once accepted, 10 months typically to decide to approve.
That's year right there.

It is likely that the AD NDA will not be filed until Rett NDA is filed. That will be before EOY I hope.
So add some months to that year for Rett to get filed.

AD could be shortened up a bit if the company files for priority review which, if the FDA granted that, would shorten the 10 months to 6 months.

Missling has said he wants that $100,000,000 value for the pediatric Rett voucher. That means that pediatric Rett has to be APPROVED before AD is approved.

How Missling will choose to manage the timelines for the two NDA's is unknown.

The real folly is ignoring the progress the company has made.

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