• Spectrum (SPPI) EOquin for non-muscle invasive bladder cancer

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    Biotech Forecast
    Clinical and Regulatory
    Event Type: PDUFA
    Timing: 12/11/2016
    Designation(s): None

    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: non-muscle invasive bladder cancer
    Lead Indication?: No
    Treatment Name: EOquin

    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: Ongoing
    Event Discussion: Forums
    Event Announcement(s): http://investor.sppirx.com/releasedetail.cfm?releaseid=959739
    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

    Quote
    • EOquin, a potent tumor-activated drug for non-muscle invasive bladder cancer: Spectrum filed an NDA based on the previous Phase 3 studies. The FDA accepted the NDA and has given Spectrum a PDUFA date of December 11, 2016. The FDA also indicated that it plans to hold an advisory committee meeting regarding the NDA. The Company is actively enrolling an additional randomized, placebo-controlled Phase 3 trial under the SPA agreement. The Phase 3 study has been specifically designed to build on learnings from the previous EOquin Phase 3 studies, as well as recommendations from the FDA.

     

    Edited by Biotech Forecast

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