Posted by Michael Wonder on 10 Nov 2022
BrainStorm Cell Therapeutics receives refusal to file letter from FDA for its new biologics license application for NurOwn for the treatment of ALS
10 November 2022 - BrainStorm Cell Therapeutics today announced that the company has received a refusal to file letter from the US FDA regarding the company's new biologics license application for NurOwn for the treatment of amyotropic lateral sclerosis.
The FDA has indicated that the company can request a Type A meeting to discuss the content of the refusal to file letter.
