RWE for 2nd MSB COVID-19 ARDS P3 Trial, page-547

  1. 3,968 Posts.
    lightbulb Created with Sketch. 2812
    Ah Moe !

    Hey while I’ve got you here.

    I’m thinking we get an answer on Friday US time
    as to whether the evidence is enough to
    be deemed a resubmission. Plus whether
    it is Class 1 or Class 2.

    My opinion - don’t give a stuff what the naysayers
    are on about.

    Friday - end of 14 day turnaround as stated by CBER
    Class 1- 2 month reply
    Class 2- 6 month reply
    Insufficient evidence - going to hurt

    But when you spend 9 and a half million to prove a point,
    it’s probably a good point.


    Reg



 
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