Retrophin (RTRX) Bullish Stance Reiterated at BMO as RE-024 Gets Accelerated Path To Market
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Retrophin Reaches Agreement with FDA under Special Protocol Assessment for Pivotal Trial Evaluating RE-024 in PKAN
November 10, 2016 4:05 PM ESTSAN DIEGO , Nov. 10, 2016 (GLOBE NEWSWIRE) -- Retrophin, Inc. (Nasdaq: RTRX) today announced it has reached an agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for a Phase 3 clinical trial evaluating RE-024, the Companys novel investigational replacement therapy, for the treatment of pantothenate kinase-associated neurodegeneration (PKAN). The SPA indicates concurrence by the FDA that the design of the pivotal trial can adequately support a New Drug Application (NDA) seeking U.S. approval of RE-024 for the treatment of PKAN. The Company plans to initiate... More
