Testimony Before the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee Regarding the Drug AMX0035 for Treatment of Amyotrophic Lateral Sclerosis
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In testimony before the Food and Drug Administration’s (FDA’s) Peripheral and Central Nervous System Drugs Advisory Committee, Public Citizen argued against approval of the combination drug AMX0035 (sodium phenylbutyrate and taurursodiol) for treating amyotrophic lateral sclerosis because clinical trial data failed to provide substantial evidence of effectiveness.