Milestone Pharma receives FDA refusal to file for etripamil NDA for PSVT

Milestone Pharmaceuticals Inc.

FDA issued Refusal to File letter for etripamil NDA submitted October 2023.
FDA cited insufficient completeness, requested clarification on adverse event timing in Phase 3.
FDA did not express concerns about nature or severity of adverse events.
Milestone will seek meeting with FDA to address issues and agree on path forward.
Etripamil is a self-administered nasal spray for paroxysmal supraventricular tachycardia.

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