Federal health advisers have voted overwhelmingly against recommending approval of an experimental treatment for Lou Gehrig's disease, the fatal muscle-wasting disease.
But the agency appears unwilling to overlook the failed study results and missing information in Brainstorm’s submission, including key details on manufacturing and quality control needed to establish the product’s safety.
ALS destroys nerve cells in the brain and spinal cord needed to walk, talk, swallow and — eventually — breathe. Most people die within three to five years of their first symptoms.
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