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Re: powerwalker post# 423409

Wednesday, 07/19/2023 8:07:51 AM

Wednesday, July 19, 2023 8:07:51 AM

Post# of 465232
Hi Powerwalker! I think the AD NDA is stronger with the safety/efficacy data for Rett already on the record. But, I think either NDA could be filed independently of the other.

Strategically, I think Rett should go first. The Rett NDA should be largely queued up - or at least that is what I would guide them to have done: they have the adult data, they have everything for the CMC section, they would need to add the Juvenile data. Ideally, they will have already filed the NDA prior to full EXCELLENCE data as a rolling submission - but of course we are not privy to the reasons they may or may not have taken that path.
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