BrainStorm, FDA Discuss Plans for Manufacturing of NurOwn

BrainStorm, FDA Discuss Plans for Manufacturing of NurOwn

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BrainStorm, FDA Discuss Plans for Manufacturing of NurOwn

BrainStorm Cell Therapeutics met with U.S. Food and Drug Administration (FDA) officials regarding its plans for a semi-automatic manufacturing process for NurOwn, the company’s investigational cell-based therapy for amyotrophic lateral sclerosis (ALS). Discussion at the meeting — formally called a type C meeting — covered issues that included how to evaluate future therapy modifications for comparability testing, as well as the logistics involved in sourcing starter materials and of future manufacturing production. “We are pleased…

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