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end2war

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end2war

Re: Gernee20 post# 347614

Tuesday, 02/01/2022 1:59:59 AM

Tuesday, February 01, 2022 1:59:59 AM

Post# of 517600

One small thing to note is only one nda would be needed when applying for BOTH pediatric and adult Rett syndrome approval.



Can you offer any authority for this claim?

Are there not special legal requirements to obtain regulatory approval for a pediatric indication in the US?
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