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Achillion Pharmaceuticals, Inc. Message Board

  • df2830 df2830 Oct 16, 2013 1:15 PM Flag

    Question please re FDA hold

    This time, they didn't ask for clarity as far as I can read, did they? OTOH, management said they would be in continuing discussions with them. What will they be discussing? The problem with this hold which resulted in a much sharper hit than the first one is that the FDA hasn't really extended a hand in trying to address the issues cited for keeping the hold. ANCH addressed everything they asked for, and yet they continue the hold. Unlike the June hold, this one sounds like a dead end. Which is why any resolution, or even the FDA formally defining what they want addressed or re-addressed, will take this back to June levels..

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    • "While we are disappointed that we were not able to resolve the clinical hold at this time despite having addressed all the issues, we believe the breadth of our portfolio allows us to quickly advance other all oral combination regimens for the treatment of HCV," stated Milind Deshpande, President and Chief Executive Officer of Achillion. "With our Phase 2 NS5A inhibitor, ACH-3102, we are in a position to rapidly initiate combination studies with ACH-2684, our protease inhibitor, with results expected in 2014. Further, we continue to advance our uridine-analog nucleotide, ACH-3422, with which we anticipate initiating clinical trials in the first half of 2014."

      ACH-2684 has completed all of the necessary preclinical and clinical trials necessary to support advancement into Phase 2 combination development. Achillion previously reported robust anti-viral activity with ACH-2684 as monotherapy including Phase 1b data in both non-cirrhotic and cirrhotic treatment-naïve HCV genotype (GT) 1 patients. In addition, Achillion will continue to work to resolve the clinical hold related to sovaprevir

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