{"schema_version":"secwatch.filing_event.v1","accession":"0001520138-23-000511","form_type":"8-K","ticker":"BIVI","cik":"0001580149","company_name":"BIOVIE INC.","filed_at":"2023-11-29T23:59:59+00:00","discovered_at":"2026-05-14T18:03:29.622884+00:00","generated_at":"2026-06-07T20:17:28.014652+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"BioVie Phase 3 NE3107 Alzheimer's trial misses primary endpoint; positive per-protocol trends","bullets":["Primary endpoint missed statistical significance due to exclusion of patients from 15 sites with GCP violations; sites referred to FDA.","Per-protocol analysis (57 patients) showed NE3107 cognitive and functional improvement vs placebo comparable to approved monoclonal antibodies.","NE3107-treated patients had 4.66-year age deceleration advantage vs placebo via Horvath DNA methylation clock.","Company plans to work with FDA on adaptive design to continue enrolling patients toward statistical significance."],"urls":{"canonical":"https://secwatch.observer/filing/0001520138-23-000511","json":"https://secwatch.observer/filing/0001520138-23-000511.json","markdown":"https://secwatch.observer/filing/0001520138-23-000511.md","text":"https://secwatch.observer/filing/0001520138-23-000511.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1580149/000152013823000511/0001520138-23-000511-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1580149/000152013823000511/bivi-20231129_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-07T20:17:28.014652+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"}