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.
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Amylyx’s Relyvrio: US FDA Review Shows Regulatory Flexibility Can Come In Many Forms
Pink Sheet Drug Review Profile looks at how the agency determined that Amylyx’s ‘conceptual basis’ for use of the drug’s two active ingredients to treat ALS was enough to satisfy the combination drug rule; the sponsor also was allowed to submit certain animal studies and drug-drug interaction data during the course of the NDA review.
Y-mAbs’ I-Omburtamab Offers Another Example Of The Limits To US FDA’s Regulatory Flexibility
Even in a rare disease with no approved treatments, the agency shows once again that without clear efficacy data, FDA has few options for approval.
FDA’s Peter Stein And Lessons From Makena: There Are Limits To Regulatory Flexibility
Office of New Drug head said agency was willing to apply regulatory flexibility when it granted Makena its initial accelerated approval but says to give the drug the type of flexibility sponsor Covis wants now would set a ‘troubling’ precedent.