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2020 The Year Of RAP, page-476

  1. 2,642 Posts.
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    have not posted for a while. so looking at some if the rather pointless 'personal attempts at point scoring etc' are a venting of frustrations ok that's human nature

    but inaccuracies have to be corrected FDA is process, not a binary approve/non approve

    FDA will inevitably come back with questions etc which the company has to respond to - this is process, and a very valuable process - it's not taking out a patent where it is binary - approved or not approved

    the FDA have hundreds if not thousands on products front of them . the FDA regulators are not experts, in everything - especially new tech - but all the same that's are smart people who know how to ask the right questions

    so those doomsday merchants who are saying 'fda approval is taking long blah blah ' look at what needs to be done, take a step back and consider what I have written here

    to be honest I would not employ anyone who had thus uniformed opinion

    fda process will continue up until either


    it is approved

    RAP withdraw application

    THAT IS THE TRUE BINARY

    Cheers all - Ports) currently in Townsville)
 
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