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The Food and Drug Administration was more than likely correct to reject Biohaven Pharmaceuticals’ treatment for spinocerebellar ataxia, a rare and debilitating neurodegenerative disease. At the very least, the decision announced Tuesday night was not a surprise to anyone paying attention. Approval was a coin flip , at best.

The complete response letter has not yet been posted to the FDA website, but according to Biohaven , the agency rejected its drug, called troriluzole, due to issues that can be “inherent to real-world evidence and external control studies, including potential bias, design flaws, law of pre-specification a

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