It made it to phase III: fine, there was enough evidence in the dubious phase II to perhaps justify a further trial. But selling it to patients as an ALS thera

It made it to phase III: fine, there was enough evidence in the dubious phase II to perhaps justify a further trial. But selling it to patients as an ALS therapy in the meantime outside of that trial, when it looked very dubious that it did anything-- that was a little questionable. The FDA overruling their own advisory committee to make this possible looks like a regulatory failure.