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Ad Comm review today for Spectrum Pharma's apaziquone

Sep. 14, 2016 7:05 AM ETAssertio Holdings, Inc. (ASRT) StockASRTBy: Douglas W. House, SA News Editor4 Comments
  • The FDA's Oncologic Drugs Advisory Committee meets today to review and discuss Spectrum Pharmaceuticals' (NASDAQ:SPPI) New Drug Application (NDA) seeking approval of apaziquone, branded as Qapzola, for the immediate intravesical instillation post-transurethral resection of bladder tumors in patients with non-muscle invasive bladder cancer.
  • Draft questions
  • FDA briefing doc
  • Spectrum briefing doc
  • Update: The panel voted 14 - 0 against approval.

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