{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-22-019022","form_type":"8-K","ticker":"GLSI","cik":"0001799788","company_name":"Greenwich LifeSciences, Inc.","filed_at":"2022-07-11T23:59:59+00:00","discovered_at":"2026-05-14T18:03:57.069759+00:00","generated_at":"2026-06-24T17:41:27.065147+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA clinical hold on GLSI-100 Phase III Flamingo-01 remains; manufacturing data submitted, review ongoing","bullets":["FDA placed clinical hold on Flamingo-01 trial for GLSI-100 (GP2) in HER2/neu positive patients, citing manufacturing issues.","Company completed manufacturing of three clinical lots of GP2 that meet release specifications; third lot made on commercial automated filling line.","FDA is reviewing manufacturing data and sent follow-up questions; company has responded.","Site initiation visits being scheduled to train clinicians and activate clinical sites.","No assurance when or if clinical hold will be released; risk factor supplemented."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-22-019022","json":"https://secwatch.observer/filing/0001493152-22-019022.json","markdown":"https://secwatch.observer/filing/0001493152-22-019022.md","text":"https://secwatch.observer/filing/0001493152-22-019022.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1799788/000149315222019022/0001493152-22-019022-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1799788/000149315222019022/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-24T17:41:27.065147+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"}