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We should learn something about regulatory flexibility under the current leadership of the Food and Drug Administration when the agency renders a decision in mid-November on Biohaven Pharmaceuticals’ treatment for spinocerebellar ataxia (SCA), a rare and debilitating neurodegenerative disease.
“This is a really tough call. I’d say approval is a 50-50 shot, at best,” a Biohaven shareholder told me. I heard the same toss-up sentiment from other shareholders as well, reflecting uncertainty that seems to precede so many FDA decisions these days, exacerbated by Biohaven’s controversial data package.
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