On Wednesday, September 27, 2023, the FDA will host a public advisory committee meeting (AdComm) for BrainStorm Cell Therapeutics’ stem cell therapy NurOwn for the treatment of ALS.
The public is invited to attend the AdComm meeting via YouTube. A panel of experts will review and evaluate the data provided by BrainStorm about NurOwn’s safety and efficacy, and provide input that will help inform the FDA’s ultimate decision about NurOwn’s Biologics License Application.
The FDA invites individuals to submit written comments about NurOwn to the AdComm panel for their review by Wednesday, September 20 to be included in the packet of materials provided to the panel. In your written statements, please refer to NurOwn as “debamestrocel,” its technical name.
To submit your comments, please visit the FDA website.
We ask that any comments submitted to the committee be shared with us at email@example.com.
Please note: This AdComm session will not be the final meeting in the FDA approval process. The FDA’s decision regarding the approval of NurOwn is scheduled to be announced before the end of the year.