{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-059671","form_type":"8-K","ticker":"MIST","cik":"0001408443","company_name":"Milestone Pharmaceuticals Inc.","filed_at":"2025-06-16T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.191190+00:00","generated_at":"2026-05-19T06:12:15.979099+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Milestone submits CRL response for CARDAMYST (etripamil) PSVT NDA after Type A meeting","bullets":["Submitted CRL response to FDA on June 16, 2025, following a productive Type A meeting.","FDA will determine acceptance and set PDUFA date within 30 days.","Review timeline expected to be 2 or 6 months depending on classification.","CARDAMYST, if approved, would be the first self-administered therapy for acute PSVT episodes."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-059671","json":"https://secwatch.observer/filing/0001104659-25-059671.json","markdown":"https://secwatch.observer/filing/0001104659-25-059671.md","text":"https://secwatch.observer/filing/0001104659-25-059671.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1408443/000110465925059671/0001104659-25-059671-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1408443/000110465925059671/tm2518093d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-19T06:12:15.979099+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"}