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Affymax, Inc. Message Board

  • pharmanot pharmanot Feb 25, 2013 12:12 AM Flag

    Clinical questions

    1) Were multiple use vials left at room temperature for up to 30 days and shared between patients who died?
    2) Were anaphylatic reactions only seen with subcutaneous administration?
    3) Were patients even monitored for possible reactions for 30 minutes after injection before being released?
    4) Is the cold chain for Omontys comparable to Amgen's products to prevent product coagulation?
    4) Did reactions occur only following darbepoetin or epogen alfa?
    5) Does Fresenius provide comparable safety training and proper monitoring for Amgen products?
    6) Did all patients receive their initial dose in a clinic or any patients die who received product for first use at home?
    7) What is the true reporting rate of anaphylaxis with epogen and darboboetin beyond initial registration studies and have any deaths occurred that have not been properly reported?
    8) Will all epos receive a class black box warning for possible fatal anaphylaxis and require enhanced monitoring with first dose?

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