FDA advisers to review ALS drug funded by Ice Bucket Challenge.
approved by the FDA for the disease and its symptoms; one has been shown to extend the lives of patients by about three months.
FDA scientists, however, appeared skeptical about the benefits of the drug, saying in the briefing documents that the results of Amylyx's trial were"not robust." It's possible, he said, that a Phase 3 trial could reveal the drug doesn't work as expected, even though the Phase 2 trial showed there was an apparent benefit.
Lynch, of the University of Pennsylvania, said that after reading the FDA documents, a"flat out rejection" of the drug by the agency "would surprise me less than I was predicting last week."
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