Hey wink mate we have the right captain steering the ship Under...

Hey wink

mate we have the right captain steering the ship


Under promise, overdeliver means setting reasonable expectations and knock them out of the park.


Is there any risk that they won't approve it?
No, there's no risk they wont approve it. They have previously approved our Pentax device, they previously approved the Carl Zeiss device so the technology is proven, it's been cleared through the FDA, it's actually been cleared through the TGA and through CE market in Europe previously. This is the first time that Optiscan as a business is now submitting that application to the FDA, previously it was always our partners that would do that for us when we were operating as an OEM. There's been some learning for the business along the way and again I spoke earlier about that sort of transition, that halfway transition, part of that transition is that we're making sure that we've got the right knowhow inside the company to guide us through that regulatory cycle with the FDA. We're not worried about the devices not being cleared, it's just about making sure it's cleared in the right way for the right indication. It gets a little bit more complex when you start to talk about specifics with the FDA so we're just trying to get really good guidance from them around that and then we'll launch into the US studies.
We currently have studies here in Australia that are looking at using our device for breast imaging, that's a study that we got approval for earlier this year at the Royal Melbourne and that will start recruitment in a couple of months and then as we learn from that we'll then launch into studies in the US.