hi @ceviche agree the TGA approval process isn’t going to be easy so I’m glad PAR recruited an expert to help them with this process. But more so in relation to the combined EMA/FDA application. Having to jump through the hoops of two regulatory bodies at the same time I can imagine won’t be easy - may be prolonged. But hopefully the outcome will be positive based on the fact that pps has already been used for such a long time and there appears to be a significant need for it DYOR IMO
TGA, page-19
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