secwatch.observer — SEC 8-K summary
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Issuer:     BRAINSTORM CELL THERAPEUTICS INC. (BCLI)
CIK:        0001137883
Form:       8-K
Filed at:   2023-11-22T23:59:59+00:00
Accession:  0001104659-23-120495
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1137883/000110465923120495/0001104659-23-120495-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1137883/000110465923120495/tm2331310d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-23-120495

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