BrainStorm, FDA align on important aspects of upcoming NurOwn trial
BrainStorm Cell Therapeutics has reached an alignment with the U.S. Food and Drug Administration (FDA) on the chemistry, manufacturing, and controls aspects — known as CMC — of the company’s upcoming Phase 3b trial of NurOwn (debamestrocel), to be tested in people with amyotrophic lateral sclerosis (ALS). This…