"Will the FDA recognise these trials as valid, or will they be annoyed that we went via the "back door"?"
That's a valid question kogarahboy. I am guessing that Georgia was selected for the trial because their requirements are not as stringent as in some other jurisdictions.
However I have enough confidence in AVR management and their Advisory Board to believe that they know what they are doing and have planned it out very carefully so as not to impede future FIH trials in those other jurisdictions.
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