{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-23-120495","form_type":"8-K","ticker":"BCLI","cik":"0001137883","company_name":"BRAINSTORM CELL THERAPEUTICS INC.","filed_at":"2023-11-22T23:59:59+00:00","discovered_at":"2026-05-14T18:03:28.328081+00:00","generated_at":"2026-06-07T22:05:27.885485+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"BrainStorm announces FDA meeting on Dec 6 to discuss SPA for NurOwn Phase 3b in ALS","bullets":["FDA granted in-person meeting scheduled for December 6, 2023, to discuss NurOwn's regulatory path in ALS.","BrainStorm plans to seek Special Protocol Assessment (SPA) agreement for a confirmatory Phase 3b trial.","Company aims to align with FDA on re-submission requirements for Biologics License Application (BLA).","CEO states SPA agreement could de-risk program and position company for success."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-120495","json":"https://secwatch.observer/filing/0001104659-23-120495.json","markdown":"https://secwatch.observer/filing/0001104659-23-120495.md","text":"https://secwatch.observer/filing/0001104659-23-120495.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1137883/000110465923120495/0001104659-23-120495-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1137883/000110465923120495/tm2331310d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-07T22:05:27.885485+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"}