Justin Klee (L) and Josh Cohen (Amylyx)

Ad­comm votes 7-2 in fa­vor of Amy­lyx's ALS drug on sec­ond take. But first the co-CEOs had to make a pledge

Sec­ond time’s the charm for Amy­lyx and its ex­per­i­men­tal ALS drug. In an un­usu­al twist, out­side ex­perts on an FDA ad­vi­so­ry com­mit­tee vot­ed 7-2 in fa­vor of ap­prov­ing AMX0035, just months af­ter vot­ing against the drug in a first ad­comm.

Even more un­usu­al was a promise from both CDER’s neu­ro­science di­rec­tor Bil­ly Dunn and Amy­lyx’s co-CEOs that AMX0035 would be pulled from the mar­ket if the drug fails its on­go­ing Phase III PHOENIX tri­al.

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