Approval process for trials different in USA v AUS
refer video thread - bob explains it well enough
my take
we have break through device designated by FDA USA that will expedite communication process to get approval in hand but no shortcuts , just expedited. They recognised the importance of the device to help us get through process
Would have to file separate applications for MRI and MRX in USA, time consuming.
but in Aus , can apply for MRX and MRI in same approval process.
the results in AUS will be enough for a massive market wake up.
then can move to pivotal study in USA, was my understanding.
have you watched video thread ?
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