BrainStorm announces FDA ADCOM to review NurOwn BLA

BrainStorm announced that the FDA will hold an Advisory Committee Meeting, or ADCOM, to discuss the company’s Biologics License Application, or BLA, for NurOwn for the treatment of amyotrophic lateral sclerosis, or ALS. Given the goal to proceed to an ADCOM as expeditiously as possible, BrainStorm requested that the Center for Biologics Evaluation and Research utilize the FDA’s File Over Protest procedure and has filed an amendment to the BLA which responds to most of the outstanding questions the FDA has posed. "The FDA provided us with more than one path to an ADCOM for NurOwn. Our goal has always been to make NurOwn available to people living with ALS as quickly as possible, therefore we chose the File Over Protest pathway since this offered the fastest path to an ADCOM and regulatory decision relative to other pathways provided by the FDA," said Chaim Lebovits, President and CEO of BrainStorm. "The ALS community needs additional treatment options now, and we firmly believe our data support regulatory approval of NurOwn. We are grateful to the FDA for the opportunity to have the clinical evidence supporting NurOwn reviewed."