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Alston & Bird Health Care Week In Review, July 30, 2021 - Food, Drugs, Healthcare, Life Sciences

Alston & Bird Health Care Week In Review, July 30, 2021 - Food, Drugs, Healthcare, Life Sciences
mondaq.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from mondaq.com Daily Mail and Mail on Sunday newspapers.

MYND Life Sciences Inc Establishes Scientific Advisory Board

MYND Life Sciences Inc Establishes Scientific Advisory Board

MYND Life Sciences Inc Establishes Scientific Advisory Board
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BrainStorm Announces High-Level FDA Feedback on NurOwn® ALS Clinical Development Program

Share this article Share this article NEW YORK, Feb. 22, 2021 /PRNewswire/ BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today that it recently met with senior leadership from the U.S. Food and Drug Administration (FDA) and received FDA feedback on a high-level data summary from the NurOwn (autologous MSC-NTF cells) ALS Phase 3 clinical trial. The FDA concluded from their initial review that the current level of clinical data does not provide the threshold of substantial evidence that FDA is seeking to support a Biologics License Application (BLA). In addition, the FDA advised that this recommendation does not preclude Brainstorm from proceeding with a BLA submission. 

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