US FDA Approval, page-5

My research and calling on some industry contacts is it depends on how you structure the submission . You might decide to do some testing in the USA which we know from previous Aust trials isn't a massively exhaustive process or you might not do any and rely on existing results. So i got varied responses .

In conclusion there isn't a definitive answer I guess we will have to wait and find out from the company what submission strategy they will adopt. I'm sure that will take the form of a news update.

But they did set themselves a milestone of achieving it in Q1 2018, which means they probably already are talking about it at a board level