Roth Capital Remains Cautiously Optimistic on Spectrum Pharma (SPPI) Following Apaziquone Phase 3 SPA Agreement

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Go back to Roth Capital Remains Cautiously Optimistic on Spectrum Pharma (SPPI) Following Apaziquone Phase 3 SPA Agreement

Spectrum Pharma (SPPI) Enters Agreement with U.S. FDA on Apaziquone Phase 3 SPA

August 17, 2015 7:05 AM EDT

Spectrum Pharma (Nasdaq: SPPI) announced that the company has reached agreement with the U.S. Food and Drug Administration (FDA) on the Special Protocol Assessment (SPA) of the planned Phase 3 clinical trial of its novel, potent pro-drug, apaziquone. This trial will further evaluate the intravesical use of apaziquone for the treatment of patients with non-muscle invasive bladder cancer (NMIBC) as one or two instillations, immediately following transurethral resection of bladder tumor (TURBT).

Spectrums agreement with the FDA on the SPA represents a significant milestone for bladder cancer patients, said Rajesh C. Shrotriya, MD,... More