{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-040387","form_type":"8-K","ticker":"OTLK","cik":"0001649989","company_name":"Outlook Therapeutics, Inc.","filed_at":"2026-04-07T23:59:59+00:00","discovered_at":"2026-05-14T18:02:32.661364+00:00","generated_at":"2026-05-15T07:02:41.495678+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.55,"confidence":"high","headline":"Outlook Therapeutics FDA accepts FDRR for ONS-5010; meeting set for April 2026","bullets":["FDA accepted Formal Dispute Resolution Request for ONS-5010/LYTENAVA (bevacizumab) for wet AMD.","Meeting with deciding official scheduled for April 2026; follows Type A meeting on March 2, 2026.","Company cites NORSE TWO and NORSE EIGHT data supporting efficacy/safety; no safety concerns raised.","If approved, ONS-5010 would be first FDA-approved ophthalmic bevacizumab with standardized manufacturing."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-040387","json":"https://secwatch.observer/filing/0001104659-26-040387.json","markdown":"https://secwatch.observer/filing/0001104659-26-040387.md","text":"https://secwatch.observer/filing/0001104659-26-040387.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926040387/0001104659-26-040387-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926040387/tm2611268d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T07:02:41.495678+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"}