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    Medivation (MDVN) PDUFA of XTANDI for MCR Prostrate Cancer

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    Biotech Forecast
    Clinical and Regulatory
    Event Type: PDUFA
    Timing: 10/22/2016
    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: Metastatic Castration-Resistant Prostate Cancer
    Lead Indication?: No
    Treatment Name: XTANDI(R) (enzalutamide)

    Likelihood of event success varies depending on disease, treatment and lead indication classification.
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    Company Information
    Co. Name: Medivation
    Stock Symbol: MDVN
    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://investors.medivation.com/releasedetail.cfm?ReleaseID=956224
    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

    FDA Accepts for Review Supplemental New Drug Application for XTANDI(R) (enzalutamide) Capsules in Metastatic Castration-Resistant Prostate Cancer With Data From Head-to-Head Studies of Enzalutamide Versus Bicalutamide


    SAN FRANCISCO, CA and TOKYO, JAPAN -- (Marketwired) -- 02/22/16 -- Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TSE: 4503) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) that they have submitted for XTANDI® (enzalutamide) capsules in metastatic castration-resistant prostate cancer (mCRPC), which includes findings from the Phase 2 TERRAIN and STRIVE studies, to update the relevant clinical sections within the current indication. Enzalutamide is approved by the FDA for the treatment of patients with mCRPC. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is October 22, 2016.


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