secwatch.observer — SEC 8-K summary
======================================

Issuer:     BRAINSTORM CELL THERAPEUTICS INC. (BCLI)
CIK:        0001137883
Form:       8-K
Filed at:   2023-06-06T23:59:59+00:00
Accession:  0001104659-23-068364
Event type: regulatory
Sentiment:  neutral
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA schedules advisory committee meeting for BrainStorm's NurOwn BLA on Sept 27, 2023
--------------------------------------------------------------------------------

- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1137883/000110465923068364/0001104659-23-068364-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1137883/000110465923068364/tm2317893d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-23-068364

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer