A November 2022 refuse-to-file letter cited clinical and statistical issues for the stem cell therapy, which failed its Phase III clinical efficacy endpoint. However, BrainStorm has consistently asserted that NurOwn demonstrated benefit in patients with less advanced disease at baseline, and it is encouraged by regulatory flexibility FDA recently has shown for the neurodegenerative disease.
Will the FDA's current regulatory flexibility in ALS serve as a tailwind for NurOwn's approval? • Source: Shutterstock
BrainStorm Cell Therapeutics Inc. is taking an unusual regulatory route to the US Food and Drug Administration advisory committee meeting it wanted for NurOwn, its stem cell therapy for amyotrophic lateral sclerosis.
The FDA has agreed to convene an advisory committee review of the NurOwn biologics license application, which is being filed over protest following a refuse-to-file action, the company said on...
