STAT+: Why Biohaven will test the FDA’s regulatory limits  

Biohaven could be set to win approval of a new drug based on FDA flexibility, or —depending on your point of view — lowered approval standards.

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I love a good regulatory debate. Biohaven Pharmaceuticals has given us a new one to chew over. 

On Monday, the company said it planned to submit a marketing application to the Food and Drug Administration before the end of the year, seeking approval for an experimental drug called troriluzole to delay progression of spinocerebellar ataxia (SCA), a rare and debilitating neurodegenerative disease.

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