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Those advocates still face one giant hurdle: FDA regulators say the treatment hasn't been shown to work. But with the backing of thousands of ALS patients, Brainstorm took the rare step of “filing over protest,” essentially forcing the agency to render a decision. Still, ALS patients see reasons for optimism. At Wednesday’s meeting, people with such reservations are certain to be outnumbered by appeals from ALS patients and their families. That compromise would be similar to FDA's approach to Relyvrio last year, another ALS drug with questionable data.
Persons: Lou Gehrig’s, drugmaker, they’re, , Marc Scheineson, Brian Wallach, Wallach, , Brainstorm’s, NurOwn, Patricia Manhardt, Anthony Windebank, reanalyzing, weren’t, Terry Heiman, Patterson, it’s, Holly Fernandez Lynch, Matthew Perrone Organizations: WASHINGTON, Drug Administration, FDA, drugmakers, Congress, Obama White House, ALS Association, Mayo Clinic, Physicians, Temple University, University of Pennsylvania, Twitter, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group, AP
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