{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-23-111088","form_type":"8-K","ticker":"MIST","cik":"0001408443","company_name":"Milestone Pharmaceuticals Inc.","filed_at":"2023-10-24T23:59:59+00:00","discovered_at":"2026-05-14T18:03:28.938437+00:00","generated_at":"2026-06-09T13:49:50.352368+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Milestone files NDA for etripamil; Phase 3 showed 2x efficacy, 3x speed vs placebo","bullets":["Submitted NDA to FDA for etripamil (CARDAMYST) for paroxysmal supraventricular tachycardia (PSVT) on Oct 24, 2023.","Pivotal Phase 3 RAPID trial published in The Lancet; etripamil restored normal rhythm 2x more effectively and 3x faster than placebo.","FDA 60-day filing review period to determine completeness; if accepted, standard 10-month review expected.","Brand name CARDAMYST conditionally approved by FDA; commercial preparations underway for anticipated launch."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-111088","json":"https://secwatch.observer/filing/0001104659-23-111088.json","markdown":"https://secwatch.observer/filing/0001104659-23-111088.md","text":"https://secwatch.observer/filing/0001104659-23-111088.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1408443/000110465923111088/0001104659-23-111088-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1408443/000110465923111088/tm2329058d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-09T13:49:50.352368+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}