Spectrum Pharmaceuticals Reaches Special Protocol Assessment Agreement With FDA on Phase 3 Trials for EOquin

Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) announced that an agreement with the U.S. Food and Drug Administration (FDA) has been reached under the Special Protocol Assessment (SPA) procedure for the Company's non-invasive bladder cancer drug candidate EOquin. The SPA process allows for an agreement between Spectrum Pharmaceuticals and the FDA on the design of a study, including clinical drug supply, pivotal trial design, clinical endpoints, conduct, data analysis, and other clinical trial issues, and is intended to provide assurance that if pre-specified trial results are achieved, they may serve as the primary basis for an efficacy claim in support of a New Drug Application (NDA) by the...

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