• Flexion Therapeutics (FLXN) NDA Filing of Zilretta (FX006) for Osteoarthritis of the Knee

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    Clinical and Regulatory
    Event Type: NDA Submission
    Timing: Q4 2016
    Designation(s): None

    This event is set for a broad date range and therefore the exact timing is unknown. This adds a degree of risk.
    FDA special designations may increase the likelihood of success and decrease the time to approval.
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    Disease and Treatment
    Disease: Other
    Indication: Osteoarthritis of the Knee
    Lead Indication?: Yes
    Treatment Name: Zilretta (FX006)

    Likelihood of event success varies depending on disease, treatment and lead indication classification.
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    Company Information
    Co. Name: Flexion Therapeutics
    Stock Symbol: FLXN
    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://ir.flexiontherapeutics.com/releasedetail.cfm?ReleaseID=982724
    Partnership: No

    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

    "With positive clinical data from our pivotal registration trials that were presented at OARSI and the subsequent written indication from the FDA that the safety and efficacy data from the registration program for Zilretta are ‘acceptable to support filing of an NDA submission,' we moved forward in bolstering our commercial executive team and are now poised to submit an NDA with the FDA in the fourth quarter of this year. Our goal is to make Zilretta available to the many millions of knee osteoarthritis (OA) patients who lack good pain-relief options," said Michael Clayman, M.D., President and Chief Executive Officer of Flexion.

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