IMPORTANT FDA DECISION FOR NEW DRUG APPLICATION FOR ALS
On March 29th, the FDA’s Advisory Committee voted 4 (yes) and 6 (no) that AMX0035 is effective in the treatment of ALS based on the data from the Phase 2 CENTAUR clinical trial. The committee’s recommendations are non-binding, and we continue to advocate for a timely approval given the acknowledged safety profile for AMX0035. Read more in our recently published editorial in the Annals of Neurology. > > We look forward to the FDA’s final decision, which is expected on June 29.
Source: https://www.massgeneral.org/neurology/als/support/