{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-024189","form_type":"8-K","ticker":"OTLK","cik":"0001649989","company_name":"Outlook Therapeutics, Inc.","filed_at":"2026-03-05T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.757768+00:00","generated_at":"2026-05-15T19:42:06.204496+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.55,"confidence":"high","headline":"Outlook Therapeutics updates on Type A meeting with FDA for ONS-5010; no definitive resolution","bullets":["Type A meeting held with FDA to discuss December 30, 2025 Complete Response Letter for ONS-5010 BLA.","FDA had requested confirmatory evidence of effectiveness; no safety concerns identified by FDA.","Company expects continued discussions to clarify agency views on confirmatory evidence.","ONS-5010 met primary endpoints in Phase 3 NORSE TWO trial; NORSE EIGHT provided confirmatory efficacy/safety data.","If approved, ONS-5010 would be first FDA-approved ophthalmic bevacizumab with US manufacturing supply chain."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-024189","json":"https://secwatch.observer/filing/0001104659-26-024189.json","markdown":"https://secwatch.observer/filing/0001104659-26-024189.md","text":"https://secwatch.observer/filing/0001104659-26-024189.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926024189/0001104659-26-024189-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926024189/tm268164d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T19:42:06.204496+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"}