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

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

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