{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-027262","form_type":"8-K","ticker":"MIST","cik":"0001408443","company_name":"Milestone Pharmaceuticals Inc.","filed_at":"2024-02-26T23:59:59+00:00","discovered_at":"2026-05-14T18:03:24.086140+00:00","generated_at":"2026-06-05T14:54:39.711626+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Milestone Pharma plans to resubmit NDA for etripamil in 2Q2024 after FDA Type A meeting","bullets":["FDA indicated that timing of adverse events had minimal impact on overall etripamil safety profile.","No additional clinical efficacy or safety trials required before NDA resubmission; standard review expected.","NDA resubmission for paroxysmal supraventricular tachycardia (PSVT) planned for 2Q2024.","Cash conservation measures extend operating runway into mid-2025, covering expected PDUFA date.","Upon FDA approval, Milestone would receive a $75M payment under an existing royalty agreement."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-027262","json":"https://secwatch.observer/filing/0001104659-24-027262.json","markdown":"https://secwatch.observer/filing/0001104659-24-027262.md","text":"https://secwatch.observer/filing/0001104659-24-027262.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1408443/000110465924027262/0001104659-24-027262-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1408443/000110465924027262/tm247232d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-05T14:54:39.711626+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"}