Indeed. I believe the FDA is genuinely motivated to approve life...

Indeed. I believe the FDA is genuinely motivated to approve life changing therapies as quickly and safely as they can. I don't think they have an eye on the business impact on the incumbents. I also don't think they give a hoot whether the sponsoring company is American or Australian. Their job is to deliver effective therapies safely and fairly to the American public, and it doesn't matter who brings it.

It is of course important to have people who understand the FDA's process and expectations and how to effectively navigate the very complex business of registration. But I think its pretty clear we have that.