{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-013470","form_type":"8-K","ticker":"OTLK","cik":"0001649989","company_name":"Outlook Therapeutics, Inc.","filed_at":"2026-02-11T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.757141+00:00","generated_at":"2026-05-16T03:19:49.117420+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"confidence":"high","headline":"Outlook Therapeutics requests Type A FDA meeting after CRL for wet AMD drug ONS-5010","bullets":["CRL dated Dec 30, 2025 cited lack of substantial evidence; company believes it contradicts alignment from Sept 2025 meeting.","Phase 3 NORSE TWO met primary endpoint (15-letter gain at 12 months); NORSE EIGHT missed primary at 8 weeks.","ONS-5010/LYTENAVA is already approved and commercially available in EU and UK for wet AMD.","FDA has not raised safety concerns; company plans to pursue resolution via Type A meeting."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-013470","json":"https://secwatch.observer/filing/0001104659-26-013470.json","markdown":"https://secwatch.observer/filing/0001104659-26-013470.md","text":"https://secwatch.observer/filing/0001104659-26-013470.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926013470/0001104659-26-013470-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926013470/tm265994d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T03:19:49.117420+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"}