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abew4me

02/11/22 8:44 AM

#350763 RE: blu_1 #350721

Good post, blu.

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Quote: Expanded Access is to generate buzz within Rett community and to get them talking about it and subsequently pressuring FDA to approve. The more people in it experiencing benefit, the more FDA will take notice and be influenced. Once approval overseas, that will also pressure FDA, rather than making American patients waiting additional years to see it approved.