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BrainStorm Hoping For Advisory Committee After FDA Refuses To File BLA For Its ALS Cell Therapy

 
• By Derrick Gingery

BrainStorm, which has a history of antagonizing FDA with direct appeals to patients for NurOwn, tells investors that public elements of an adcomm could be ‘persuasive,’ but first step will be formal meeting request to try to overcome the RTF. Firm sees Relyvrio as template for success.

ALS neurons
A confirmatory trial is one possibility that BrainStorm will discuss with the FDA following NurOwn's refuse-to-file letter. • Source: Shutterstock

BrainStorm Cell Therapeutics Inc. is hoping a US Food and Drug Administration advisory committee meeting can save its ALS cell therapy candidate NurOwn (autologous MSC-NTF cells) after the application received a refuse-to-file action.

NurOwn uses stem cells to deliver neurotrophic factors and immunomodulatory cytokines directly to the site of damage to slow or stabilize disease progression.

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