Ann: Rett Syndrome NDA accepted for Priority Review by FDA, page-77

I see the FDA approved Filspari on Friday albeit the original PDUFA priority review date of Nov 17 2022 was extended by 3 months on the 14 Oct 22 (over a month out) after the FDA requested changes to risk mitigation strategy (REMs). Considering that we are less than 3 weeks away from our PDUFA date of the 12.03.23, I assume it is reasonable to think it's all systems go for Trofinetide and the FDA issuing their decision. Safety has not really been an issue (minor diarrhoea issues aside), efficacy has been proven in two primary end-points so...........

Filspari Article 14 Oct 22
https://www.fiercebiotech.com/biotech/fdas-liver-safety-request-set-delay-decision-traveres-kidney-drug