Roth Capital Remains Cautiously Optimistic on Spectrum Pharma (SPPI) Following Apaziquone Phase 3 SPA Agreement
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Spectrum Pharmaceuticals Announces Agreement with FDA on the Special Protocol Assessment (SPA) for the Upcoming Apaziquone Phase 3 Trial in Patients with Non-Muscle Invasive Bladder Cancer (NMIBC)
August 17, 2015 7:00 AM EDTCompany is on Track for Apaziquone NDA Filing by Year End Based on Pooled Data from Two Completed Phase 3 Studies that Showed a Statistically Significant Reduction in 2-Year Recurrence Rates (p-value = 0.0218) Learnings From Earlier Phase 3 Program and FDAs Comments Incorporated in New Phase 3 Study Design New Phase 3 Study Would Satisfy FDAs Requirement of Initiating an Additional Phase 3 Study Before Apaziquone NDA Submission NMIBC is the Fifth Most Common Cancer in the U.S. With Highest Per Patient Cost and... More
