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  1. After receiving a Complete Response Letter in October, Spectrum was granted a Type A meeting with the FDA on November 6, 2015. Within days, the company resubmitted the NDA and received a PDUFA date of May 9, 2016. If approved, we plan to launch Evomela with our existing sales force.
  2. HENDERSON, Nev.--(BUSINESS WIRE)--Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced that the U.S. Food and Drug Administration (the “FDA”) has accepted the EOquin® (apaziquone for intravesical instillation) New Drug Application (NDA) for review. The FDA also indicated that it plans to hold an advisory committee meeting regarding the NDA. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of December 11, 2016.