Yes it is. While in theory the FDA will give its approval on the basis of non-USA data, in practice they always want to see data from a significant US cohort. Imagine if there was no Australian data, does anyone think that the FDA would allow BOT to progress to a Phase III trial on the basis of the USA trial data?
I can't comment on if BOT will need to raise more money again for a Phase III trial. If they have to repeat the USA Phase II trial I don't know how long that will take or how much it will cost. $44 million should go a long way for a 12 week trial design run outside of a hospital.
BOT may choose to start the Phase III trials in Australia (you normally need to do two pivotal Phase III trials) while they sort out the issue(s) with the USA trial. It will be a judgement call by management of what is the best way forward, but they really need to identify what is the issue in the USA first.
Ann: BTX 1503 Acne Phase 2 Study Results Presentation, page-485
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