FDA seeks to dampen expectations on BrainStorm ALS therapy amid patient push for access

In the face of a social media campaign by patients advocating for the access to BrainStorm’s ALS therapy NurOwn, FDA took the highly unusual step of commenting on the results of a Phase III trial before taking a regulatory action. 

“From data that have been communicated to the ALS community, there was a lot of hope that this product could provide at least a modest breakthrough in the management of ALS, if not something more substantial,” FDA said of the  BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI) therapy in a statement. ...