{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-23-031612","form_type":"8-K","ticker":"GRCE","cik":"0001444192","company_name":"Grace Therapeutics, Inc.","filed_at":"2023-07-05T23:59:59+00:00","discovered_at":"2026-05-14T18:03:33.938248+00:00","generated_at":"2026-06-13T12:38:09.079008+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Acasti aligns with FDA on GTX-104 Phase 3 safety trial protocol; STRIVE-ON to start Q4 2023","bullets":["FDA confirmed alignment on STRIVE-ON trial design and dosing regimen for GTX-104 in aSAH patients.","STRIVE-ON will enroll ~100 patients at ~25 US hospitals; primary endpoint is safety vs oral nimodipine.","GTX-104 administered to >150 healthy volunteers with comparable safety to oral nimodipine to date.","Cash runway projected through potential NDA submission in H1 2025.","First patient dosing expected in Q4 2023; NDA submission targeted for first half of 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-23-031612","json":"https://secwatch.observer/filing/0000950170-23-031612.json","markdown":"https://secwatch.observer/filing/0000950170-23-031612.md","text":"https://secwatch.observer/filing/0000950170-23-031612.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1444192/000095017023031612/0000950170-23-031612-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1444192/000095017023031612/acst-20230705.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-13T12:38:09.079008+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"}