BrainStorm Cell Therapeutics Inc. expects to focus a new Phase III trial for NurOwn (debamestrocel) on amyotrophic lateral sclerosis patients with mild or less advanced disease, the company said in announcing withdrawal of the US biologics license application for the mesenchymal stromal cell therapy.
BrainStorm Eyes New Phase III Trial For NurOwn In Mild ALS Following BLA Withdrawal
Highly negative FDA advisory committee review and subsequent discussions with the agency made clear the only path forward was a new study, company executives said. Troubled application shows the limits of FDA’s willingness to exercise regulatory flexibility.
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