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Supernus Pharmaceuticals, Inc. (SUPN) Message Board

daleedwards99 1 post  |  Last Activity: Dec 18, 2014 12:13 PM Member since: May 16, 2014
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  • Portage's Biohaven Receives Response from FDA to its Pre-IND Meeting Request

    symbol PTGEF on OTCBB....can it be? a penny stock?
    Declan Doogan M.D., CEO of Portage and Executive Chairman of BioHaven, commented, "Overall, the written response received from the FDA was in-line with our expectations and no issues were raised that would prevent the timely filing of our IND or initiation of our first Phase 1 study. This is very good news for Biohaven and reflects the team's expertise in the submission of high quality regulatory documents." 
    "With this feedback from the FDA, Biohaven has already initiated the work streams necessary to file our IND for BHV-0223. We are excited about completing the optimization of our commercial formulation of BHV-0223, submitting the IND and initiating clinical studies in 2015," commented Robert Berman M.D.  Chief Medical Officer of Biohaven and Adjunct Professor of Psychiatry, Yale University School of Medicine.
    BHV-0223 is a reformulated glutamate modulating agent being developed for treatment-resistant mood and general anxiety disorders. (GAD)

8.65+0.13(+1.53%)Dec 26 4:00 PMEST

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