I think the FDA is not an issue with trials being done in Australia. By this i mean that many companies conduct phase 1 and or phase 2 trials outside of USA before presenting data to FDA. It is often seen as a much more economic path and as long as the data is formatted correctly there should be no issue with any FDA application. Another example is Rce who have FDA fast track approval for their synthetic anti biotic yet are conducting initial trials here outside FDA structure for later presentation.
Breakthrough Device Regulatory win, page-16
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