• Spectrum Pharmaceuticals (SPPI) PDUFA of Evomela for conditioning treatment prior to hematopoietic stem cell transplantation in patients with multiple myeloma

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    Clinical and Regulatory
    Event Type: PDUFA
    Timing: 05/09/2016
    Designation(s): Orphan Drug

    This event is set for a specific date and makes planning easier. However, specific dates may change.
    FDA special designations may increase the likelihood of success and decrease the time to approval.
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    Disease and Treatment
    Disease: Oncology
    Indication: Conditioning treatment prior to hematopoietic stem cell transplantation in patients with multiple myeloma
    Lead Indication?: No
    Treatment Name: EVOMELA™ (melphalan)

    Likelihood of event success varies depending on disease, treatment and lead indication classification.
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    Company Information
    Co. Name: Spectrum Pharmaceuticals
    Stock Symbol: SPPI
    Shares Traded: NASDAQ

    The OTC BB and OTC Markets have less stringent reporting and financial requirements than the NASDAQ and NYSE. This may increase the level of risk for investors. Smaller size may have an influence on likelihood of success.
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    Event Status
    Event Outcome: Positive
    Event Discussion: Forums
    Event Announcement(s): http://www.sec.gov/Archives/edgar/data/831547/000083154716000053/exhibit991q42015.htm
    Partnership: Yes

    Partnerships help smaller biotech companies finance the long approval process. Partnership also provides validation the clinical program may be a worthy investment.
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    Detailed Event Description from Company Announcement

    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.

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