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Amylin Pharmaceuticals, Inc. Message Board

  • augustempress augustempress Apr 29, 2005 10:32 AM Flag

    Briefing - AMLN again

    10:26 AMLN Amylin Pharms: Exenatide approved, monotherapy approvable, label potential concern - Thomas Weisel (16.40 -1.78)

    -Update- Thomas Weisel notes that AMLN announced the FDA approval of exenatide this morning, in line with its PDUFA date. While they view exenatide being approvable as a monotherapy as good, they worry that the label may limit the available patient population beyond investor expectations. They note the label states Byetta is not a substitute for insulin in insulin-requiring patients, and states that the drug should not be used in type 1 diabetics or for the treatment of diabetic ketoacidosis. Firm believes that the restriction may be specific for type 1 diabetics, was expected, but believe that investors may view the warning as market limiting in type 2 patients. They think the restriction may prevent type 2 diabetics who are already receiving insulin therapy to be treated with Byetta. They will look for more clarity on the label on the conference call at noon.

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