{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-25-016826","form_type":"8-K","ticker":"ADIL","cik":"0001513525","company_name":"ADIAL PHARMACEUTICALS, INC.","filed_at":"2025-02-25T23:59:59+00:00","discovered_at":"2026-05-14T18:03:03.850317+00:00","generated_at":"2026-05-26T04:44:17.290840+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Adial gets FDA nod for AD04 in vitro bridging strategy; Phase 3 path clear","bullets":["FDA agreed with proposed 505(b)(2) bridging strategy for AD04, leveraging AD04-103 study and in vitro data.","Adial to manufacture clinical supplies for Phase 3 program in 2025 following FDA confirmation.","Submission was made on Nov 19, 2024; FDA feedback received Feb 25, 2025.","AD04 is a genetically targeted therapy for Alcohol Use Disorder; ONWARD Phase 3 trial completed.","CEO Cary Claiborne says milestone brings AD04 closer to regulatory approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-25-016826","json":"https://secwatch.observer/filing/0001213900-25-016826.json","markdown":"https://secwatch.observer/filing/0001213900-25-016826.md","text":"https://secwatch.observer/filing/0001213900-25-016826.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1513525/000121390025016826/0001213900-25-016826-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1513525/000121390025016826/ea0231982-8k_adial.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-26T04:44:17.290840+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"}