{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-23-068364","form_type":"8-K","ticker":"BCLI","cik":"0001137883","company_name":"BRAINSTORM CELL THERAPEUTICS INC.","filed_at":"2023-06-06T23:59:59+00:00","discovered_at":"2026-05-14T18:03:38.039322+00:00","generated_at":"2026-06-14T06:20:28.176140+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA schedules advisory committee meeting for BrainStorm's NurOwn BLA on Sept 27, 2023","bullets":["FDA Cellular, Tissue and Gene Therapies Advisory Committee to review NurOwn BLA for ALS on September 27, 2023.","PDUFA target action date set for December 8, 2023.","Company states confidence in data supporting regulatory approval and commitment to ALS community.","BrainStorm notes FDA regulatory flexibility and ongoing work with ALS experts on rigorous clinical study."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-068364","json":"https://secwatch.observer/filing/0001104659-23-068364.json","markdown":"https://secwatch.observer/filing/0001104659-23-068364.md","text":"https://secwatch.observer/filing/0001104659-23-068364.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1137883/000110465923068364/0001104659-23-068364-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1137883/000110465923068364/tm2317893d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-14T06:20:28.176140+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"}