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Re: Gator328 post# 422356

Tuesday, 07/11/2023 3:32:15 PM

Tuesday, July 11, 2023 3:32:15 PM

Post# of 468507
Missling has repeatedly said he wants the voucher so that means Rett first.

AD doesn't have fast track like Rett does so that means the NDA has to be complete before submission unlike Rett which can be submitted in sections as they are completed.

Fast track means a review response time frame of 6 months for Rett vs the 10 months for AD once the NDA is submitted and accepted.

One can make a reasonably strong argument that having 2-73 approved for Rett improves the chances of approval for AD. Then there is the $100,000,000 worth of voucher that comes with pediatric Rett approval.

Bottom line is that waiting for Rett first doesn't slow down AD approval much and has clear benefits.

Sarcasm. Because killing people is frowned upon.

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