---
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"
generated_at: "2026-06-07T22:05:27.885485+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# BrainStorm announces FDA meeting on Dec 6 to discuss SPA for NurOwn Phase 3b in ALS

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-120495
- JSON: https://secwatch.observer/filing/0001104659-23-120495.json
- Plain text: https://secwatch.observer/filing/0001104659-23-120495.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.