Spectrum Pharma (SPPI) Receives FDA Complete Response Letter Related to QAPZOLA NDA

November 18, 2016 6:05 AM EST

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Spectrum Pharma (NASDAQ: SPPI) disclosed the following in a U.S. SEC filing on Friday:

Item 8.01 - Other Events.

On November 17, 2016, Spectrum Pharmaceuticals, Inc. (the “Company”) received a Complete Response Letter from the U.S. Food and Drug Administration (the “FDA”) with respect to the Company’s New Drug Application for QAPZOLA (apaziquone for intravesical instillation). On November 15, 2016, the Company met with the FDA to discuss the strategy for further development of QAPZOLA. Based on the discussions, the Company is evaluating a new smaller study that would replace the ongoing Phase 3 program in which enrollment has been stopped.



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