{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-23-019804","form_type":"8-K","ticker":"CYDY","cik":"0001175680","company_name":"CytoDyn Inc.","filed_at":"2023-12-14T23:59:59+00:00","discovered_at":"2026-05-14T18:03:28.421291+00:00","generated_at":"2026-06-07T12:32:35.656845+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"CytoDyn: FDA lifts partial clinical hold, imposes new full hold on revised protocol; expects January 2024 submission","bullets":["Partial clinical hold from March 2022 lifted by FDA in December 2023.","New full clinical hold placed on proposed HIV trial protocol submitted November 2023.","Company to incorporate FDA feedback and submit amended protocol by January 2024.","Views partial hold resolution as significant step; full hold expected resolved after response.","Proposed HIV study aims to establish leronlimab's mechanism of action cost-effectively."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-23-019804","json":"https://secwatch.observer/filing/0001558370-23-019804.json","markdown":"https://secwatch.observer/filing/0001558370-23-019804.md","text":"https://secwatch.observer/filing/0001558370-23-019804.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1175680/000155837023019804/0001558370-23-019804-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1175680/000155837023019804/cydy-20231214x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-07T12:32:35.656845+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"}