No worries LJohn, the intention is definitely to have TGA provisional approval sorted well before FDA approval.
As you say more clarity around provisional approval will be released Q4 which start in a couple of weeks.
It was highlighted in a presentation early in the year that PAR will be submitting the application (stage 2) in Q4 this year. The countdown will then begin. I think it was mentioned that we should hear back 150-200 days after submission. Please check the accuracy of this day range though.
Exciting times ahead
Ann: Paradigm Presentation to Emerging Leaders Conference, page-67
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