FDA advisers vote against ALS treatment from BrainStorm

A panel of unbiased advisers to the Food and Drug Administration voted overwhelmingly against a polarizing potential treatment for ALS on Wednesday, concluding that the medication’s messy supporting knowledge didn’t meet the usual for approval.

After a day-long assembly that included impassioned testimony from ALS sufferers, the company’s professional advisers voted 17-1 with one abstention that the case for NurOwn, a treatment from BrainStorm Cell Therapeutics, was based mostly too closely on convoluted medical trial outcomes and compelling however unreliable anecdotal proof.

“Patients and households want hope, however offering false hope may be ethically problematic,” stated panelist Lisa Lee, a bioethicist at Virginia Tech. “False hope is offered when the likelihood of a constructive end result is overestimated, and I feel that appears to be the case right here.”