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Re: Steady_T post# 324602

Thursday, 08/05/2021 1:00:03 PM

Thursday, August 05, 2021 1:00:03 PM

Post# of 465604
The case for accelerated Rett approval is simple: What else is there to help those who are suffering?

The safety issue is moot because there are years of trial data, and if early results are promising what is there to lose with approval? A P4 may be required but that too seems unlikely.

That said, I do not expect the FDA to grant Rett accelerated approval. I don't think there is a large enough population in the world who have Rett to sway the FDA to grant accelerated approval, especially considering all the other drugs for lots of other diseases without a treatment that may be more prevalent.
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