Good News Parsabiv data looks good in Lithuania

Discussion in 'Amgen' started by anonymous, Aug 27, 2016 at 6:16 AM.

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  1. anonymous

    anonymous Guest

    Andreas G has saved the company !! If we take the dataset from Lithuania there are NO CARDIAC DEATHS OR IMBALANCES IN SAFETY/MORTALITY !!

    Clearly the FDA will understand that because the patients outside of Lithuania had underlying baseline conditions at a different rate that a subgroup analysis is acceptable.

    We expect accelerated approval with a labeled indication "Parsabiv for use in Lithuania where it's better than Sensipar"
     

  2. anonymous

    anonymous Guest

    How many patients?
     
  3. anonymous

    anonymous Guest

    well there's only 18 but the label "Superior in Lithuania" is a guaranteed winner..