{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-25-087925","form_type":"8-K","ticker":"ADIL","cik":"0001513525","company_name":"ADIAL PHARMACEUTICALS, INC.","filed_at":"2025-09-16T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.180685+00:00","generated_at":"2026-05-17T06:29:34.181983+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Adial Pharmaceuticals receives FDA alignment on Phase 3 trial design for AD04 in alcohol use disorder","bullets":["FDA End-of-Phase 2 meeting held July 29, 2025; final minutes received confirming alignment on adaptive Phase 3 design.","FDA confirmed primary endpoint of zero heavy drinking days during months 5 and 6 of efficacy observation.","FDA supported biomarker stratification (AG+ subgroup, ~14% of general population) and adaptive enrichment strategy.","FDA advised pre-specifying key secondary endpoints in protocol for potential future product labeling.","CEO highlights new patent filing that may extend AD04 market exclusivity to 2045."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-25-087925","json":"https://secwatch.observer/filing/0001213900-25-087925.json","markdown":"https://secwatch.observer/filing/0001213900-25-087925.md","text":"https://secwatch.observer/filing/0001213900-25-087925.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1513525/000121390025087925/0001213900-25-087925-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1513525/000121390025087925/ea0257511-8k_adial.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T06:29:34.181983+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"}