secwatch.observer — SEC 8-K summary ====================================== Issuer: Milestone Pharmaceuticals Inc. (MIST) CIK: 0001408443 Form: 8-K Filed at: 2024-03-28T23:59:59+00:00 Accession: 0001104659-24-040008 Event type: regulatory Sentiment: neutral Materiality: 0.70 Item codes: 8.01, 9.01 LLM model: deepseek-v4-flash:cloud@v2 Milestone Pharmaceuticals resubmits NDA for etripamil nasal spray to FDA for PSVT -------------------------------------------------------------------------------- - 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. Source: EDGAR index: https://www.sec.gov/Archives/edgar/data/1408443/000110465924040008/0001104659-24-040008-index.htm Primary doc: https://www.sec.gov/Archives/edgar/data/1408443/000110465924040008/tm2410060d1_8k.htm HTML page: https://secwatch.observer/filing/0001104659-24-040008 License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer