> An uncharitable view would be that Amylyx ended up presenting the clinical package from the only angle that made it even possible to believe that the drug wor

> An uncharitable view would be that Amylyx ended up presenting the clinical package from the only angle that made it even possible to believe that the drug worked, and the FDA advisory committee ended up voting against approval... I hate to be this way, but I continue to believe that unmet medical need is not by itself enough reason to approve a drug. You need what you've always needed: efficacy and safety. Boring, tedious, expensive efficacy and safety. I can either take from this that he believes the FDA and Amylyx were engaged in irresponsible behavior letting it get this far, or that (thank God!) an ineffective drug will not be approved, and we should all be glad there is a rigorous testing process that worked again. I get the sense that he believes the former, but can't ethically say so.