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10 Q Biodel

  1. railroadman

    1,266 Posts.

    Out yesterday from their latest 10 Q. RRM
    Our lead product candidate is a glucagon emergency management, or GEM, device that is intended to treat diabetes patients experiencing severe hypoglycemia, or very low concentrations of blood glucose. GEM is comprised of lyophilized glucagon and an aqueous diluent in a proprietary injection device from Unilife Medical Solutions, Inc., or Unilife. The GEM device is a dual-chamber design that automatically reconstitutes lyophilized glucagon immediately prior to injection and features automatic needle retraction on full dose delivery. We have designed the GEM device with the goal of optimizing its ease of use for patient caregivers in an emergency.
    In the third quarter of calendar year 2014, we submitted an Investigational New Drug application, or IND, to the U.S. Food and Drug Administration, or FDA, for our GEM product candidate. We have initiated a Phase 1 clinical trial to assess the pharmacokinetic and pharmacodynamic profiles of BIOD-961, the reconstituted glucagon formulation intended for use in the GEM device, in the fourth calendar quarter of 2014. If the Phase 1 clinical trial is successful, we intend to complete the pivotal trial for our GEM product candidate by the end of calendar year 2015 and submit a New Drug Application, or NDA, to the FDA in calendar year 2016.
    Enjoy the weekend RRM.

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