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banter and General Discussion, page-10253

  1. 2,732 Posts.
    lightbulb Created with Sketch. 1812
    " then what changed their minds and on what points of consideration should be the questions" -

    I have asked this of you before- it is a fact that something has changed otherwise the submission would not be proceeding. The only public acknowledgment has been an acceptance of improvement in the potency assay.

    I think you cop the heat for arguing that what caused the second BLA, is still the status quo.

    The company thinks otherwise,

    the TYPE A thrashes things out- the TYPE C was for feedback on data , no more meetings


    - resubmit


    not long to wait now


    Reg
 
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