{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-046014","form_type":"8-K","ticker":"OTLK","cik":"0001649989","company_name":"Outlook Therapeutics, Inc.","filed_at":"2026-04-21T23:59:59+00:00","discovered_at":"2026-05-14T18:02:32.661597+00:00","generated_at":"2026-05-15T05:07:08.462557+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.65,"confidence":"high","headline":"Outlook Therapeutics completes FDA dispute resolution meeting for ONS-5010; decision expected May 2026","bullets":["Completed Federal Dispute Resolution meeting with FDA Office of New Drugs to appeal Dec 30, 2025 Complete Response Letter for ONS-5010 BLA.","Meeting addressed regulatory pathway for ONS-5010/LYTENAVA (bevacizumab-vikg) for wet AMD.","Formal FDA decision expected in May 2026; company will update after receipt.","Follows Type A meeting with Division of Ophthalmology; CEO Bob Jahr cites constructive dialogue."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-046014","json":"https://secwatch.observer/filing/0001104659-26-046014.json","markdown":"https://secwatch.observer/filing/0001104659-26-046014.md","text":"https://secwatch.observer/filing/0001104659-26-046014.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926046014/0001104659-26-046014-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926046014/tm2612353d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T05:07:08.462557+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"}