{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-029047","form_type":"8-K","ticker":"MIST","cik":"0001408443","company_name":"Milestone Pharmaceuticals Inc.","filed_at":"2025-03-28T23:59:59+00:00","discovered_at":"2026-05-14T18:03:03.543637+00:00","generated_at":"2026-05-24T02:57:08.046020+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"FDA issues Complete Response Letter for etripamil PSVT NDA; no clinical issues raised","bullets":["CRL focuses on CMC: additional nitrosamine impurity data and facility inspection required.","No clinical safety or efficacy concerns cited by FDA for CARDAMYST (etripamil) nasal spray.","Company plans to request a Type A meeting with FDA to discuss resubmission path.","Cash, cash equivalents and short-term investments of $69.7M as of Dec 31, 2024.","CEO expresses disappointment but remains committed to the program."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-029047","json":"https://secwatch.observer/filing/0001104659-25-029047.json","markdown":"https://secwatch.observer/filing/0001104659-25-029047.md","text":"https://secwatch.observer/filing/0001104659-25-029047.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1408443/000110465925029047/0001104659-25-029047-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1408443/000110465925029047/tm2510765d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-24T02:57:08.046020+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"}