BrainStorm announces Type A meeting with FDA granted for NurOwn

BrainStorm Cell Therapeutics announced that the U.S. Food and Drug Administration, FDA, has granted a Type A meeting to discuss the contents of a refusal to file letter previously issued regarding the company’s New Biologics License Application, BLA, for NurOwn for the treatment of ALS. The Type A Meeting has been scheduled to occur on January 11, 2023. "We look forward to the Type A meeting which will provide an opportunity to discuss the path forward for NurOwn in ALS, including a possible Advisory Committee Meeting," said Chaim Lebovits, Chief Executive Officer of BrainStorm. "We believe that an Advisory Committee Meeting would serve as an important part of the review process and would provide an open forum for BrainStorm, together with medical experts, statisticians, patients and other members of the ALS community to discuss the body of clinical evidence supporting NurOwn. We intend to provide a further update once we have received the minutes from the meeting, or when we have more clarity on the next steps in the approval process."