all
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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