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After refuse to file letter, FDA calls for new Firdapse study

By Michael Fitzhugh
Staff Writer

Tuesday, April 26, 2016

Shares of Catalyst Pharmaceuticals Inc. dove 49.2 percent on Tuesday after the company said the FDA will require it to submit positive results from an additional study of Firdapse in patients with Lambert-Eaton myasthenic syndrome prior to accepting its NDA.

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