FDA announcement in RettSyndrome.com
Also helps ease some doubt on the effectiveness of the phase 2 study
“Results from a previous Neuren-sponsored Phase 2 trial (NCT02715115) in 82 girls ages 5 to 15 with Rett syndrome revealed that the highest dose tested (200 mg/kg) was safe and significantly eased a range of Rett’s core symptoms, compared with a placebo.”
https://rettsyndromenews.com/2020/0...designation-to-trofinetide-for-rett-syndrome/
Ann: Rare Pediatric Disease designation received from FDA, page-3
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