regulatory
confidence high
sentiment neutral
materiality 0.70
Milestone Pharmaceuticals resubmits NDA for etripamil nasal spray to FDA for PSVT
Milestone Pharmaceuticals Inc.
- NDA resubmission for self-administered etripamil nasal spray to treat paroxysmal supraventricular tachycardia (PSVT).
- Resubmission follows FDA Type A meeting after a Refusal to File letter; no new efficacy/safety data requested.
- Package includes restructured AE timing data and reformatted data files to facilitate FDA review.