Babbanap,
The TGA as part of their fifth criteria (see below) need PAR to have a clinical trial in the designated area to be completed within 6 years. Of course we could also arrange this independently with another jurisdiction thats recognised like the EMA. At the end of the day we really do want to pursue the FDA - USA.
If we get a NO from TGA it isn't the end of the world...it would be sad...but its not the end for us.
In my mind it if its a YES that's great and it might be earlier revenue...depends on our data and when the P3 starts etc.
TGA Criteria:
Ref: https://www.tga.gov.au/resources/resource/guidance/provisional-determination-eligibility-criteria
Where we at?, page-556
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