P, The cost of and rigor of large scale trials for each territory are similar so as Oz market is not the same scale its often skipped. However once FDA approved TGA often will review that data in lieu of full re-run here. The partnership that was sought in EU was targetet to also improve FDA pathways - bang for buck.
They were looking for the right EU partner from late 2009.......
Patience rewarded, page-21
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