Posted by Michael Wonder on 15 Aug 2022
Brainstorm to seek FDA approval for ALS stem cell treatment, despite agency objections
15 August 2022 - Last year, the FDA issued a rare public statement to inform the ALS community that a negative clinical trial involving an experimental stem cell therapy from BrainStorm Cell Therapeutics did not support the filing of a marketing application.
Today, BrainStorm Cell Therapeutics announced its intention to seek approval from the FDA for its ALS treatment called NurOwn, regardless of the Agency's past opposition.
