BrainStorm submits Type A Meeting Request to U.S. FDA

BrainStorm Cell Therapeutics announced that the company has submitted a Type A Meeting Request to the U.S. Food and Drug Administration, FDA, to discuss the contents of a refusal to file letter previously issued by the FDA regarding the company’s New Biologics License Application, BLA, for NurOwn for the treatment of ALS. The Type A Meeting is expected to occur within 30 days of the FDA’s receipt of the meeting request. As previously reported, the contents of the refusal to file letter focus on topics related to chemistry, manufacturing, and controls, as well as clinical data and statistics. As part of the Type A Meeting, BrainStorm intends to discuss a path to an FDA Advisory Committee Meeting. "Participating in a Type A meeting will be an important next step towards enabling NurOwn’s advancement through the regulatory process," said Chaim Lebovits, Chief Executive Officer of BrainStorm. "The extensive briefing package submitted with our request contains a comprehensive strategy to fully address the CMC matters raised in the refusal to file letter. We anticipate achieving quick alignment with the FDA on the CMC strategy and expect that its execution will be straightforward. We therefore anticipate a Type A meeting focused primarily on discussing how we can secure an Advisory Committee Meeting, which we believe will be a critical step on NurOwn’s path towards approval as an ALS therapy."