{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-26-029837","form_type":"8-K","ticker":"GRCE","cik":"0001444192","company_name":"Grace Therapeutics, Inc.","filed_at":"2026-07-28T11:16:15+00:00","discovered_at":"2026-07-28T11:20:01.409183+00:00","generated_at":"2026-07-28T11:20:09.747680+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Grace Therapeutics gets FDA Type A minutes; no clinical deficiencies; adds U.S. manufacturing site for GTx-104","bullets":["FDA did not identify any clinical safety or efficacy deficiencies and did not request additional clinical data.","CRL items relate to cGMP compliance at contract manufacturer, leachables data, and excipient toxicology risk assessments.","Company pursuing dual-source manufacturing strategy, adding a U.S.-based contract manufacturer.","No single path to resubmission designated; resubmission may be supported by either or both manufacturers.","STRIVE-ON trial met primary endpoint with 19% reduction in clinically significant hypotension vs oral nimodipine."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-26-029837","json":"https://secwatch.observer/filing/0001140361-26-029837.json","markdown":"https://secwatch.observer/filing/0001140361-26-029837.md","text":"https://secwatch.observer/filing/0001140361-26-029837.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1444192/000114036126029837/0001140361-26-029837-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1444192/000114036126029837/ef20078866_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-07-28T11:20:09.747680+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"}