Relmada Therapeutics Provides Regulatory Update Confirming FDA Alignment on Registrational Studies Design for NDV-01 for Two Separate Indications

FDA written feedback supports:- a single-arm, open-label registrational trial in 2nd-line refractory high-grade NMIBC with CIS- a randomized vs ...
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Praxis Converts Elsunersen Study to Single-Arm Design After FDA Meeting

Praxis Precision Medicines is converting its EMBRAVE3 study of elsunersen for children suffering from a developmental disease into a single-arm study after meeting with the Food and Drug ...