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Re: mrplmer post# 453852

Monday, 03/11/2024 11:09:05 AM

Monday, March 11, 2024 11:09:05 AM

Post# of 462031
I may not be "in the know" enough to satisfy your requirements, but here it goes.

I think not on the filing of the AD NDA for the following reasons.

The company was not focused on preparing the NDA for AD when the Rett results came out. It was focused on Rett. If there was an NDA in preparation it would heave been the Rett NDA.

NDA preparation is a big undertaking that would take longer than the time since the Rett results unless they were already working on it.

I suspect the company is waiting for Rett guidance from the FDA before proceeding with any NDA. There is still an outside chance that the FDA will suggest going ahead with a Rett NDA.

Any AD filing preparation is likely to be focused on the EMA MAA. Yes there is commonality between the two. The company chose to announce the EMA process start which suggests that an NDA filing, which is more significant that starting the EMA process, would also be announced.

Nunc est Bibendum

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