Neurosense Receives U.S. Fda Confirmation of Cmc Strategy for Primec in Preparation for Pivotal Phase 3 in Als and Commercial Readiness

NeuroSense Therapeutics Ltd. announced it has concluded a successful Type D meeting with the U.S. Food and Drug Administration (FDA) for PrimeC in the treatment of amyotrophic lateral sclerosis (ALS). FDA Type D meetings are focused on a narrow set of issues at key decision points to provide timely feedback critical to move a drug development program forward. The purpose of NeuroSense's meeting with the FDA was to discuss PrimeC's chemistry, manufacturing, and controls (CMC) development plans in advance of an expected Phase 3 pivotal study and potential subsequent marketing approval.

The FDA agreed with NeuroSense's proposed CMC development plan. PrimeC has already been granted Orphan Drug Designation by the FDA and the European Medicines Agency (EMA).