Dear FDA, Step Aside So We Might Live
April 14, 2015
News Article
Dear FDA, Step Aside So We Might Live
Also published in National Review Tue. April 14, 2015.
In the next few days, the U.S. Food and Drug Administration (FDA) is expected to decide whether to accelerate approval of a new drug that might save the lives of patients with amyotrophic lateral sclerosis (ALS), Lou Gehrig’s disease. The manufacturer, Genervon Biopharmaceuticals, requested the approval of GM6 in February after finding improvements in patients during preclinical, Phase 1 and Phase 2A trial—with no negative side effects. If the FDA grants the request, patients would gain immediate access to the drug.
