I’ve had a quick read through the assessment report and overall...

I’ve had a quick read through the assessment report and overall I don’t believe it is concerning. I compare it to some of the work I’ve done in environmental impact statements for development projects where the regulator goes to town on the applicant because that’s what they should do to make sure they can prove to the public that it has been rigorously assessed before spending public money on it. And usually after another round that applicant is approved or in some cases where it is extremely obvious that it shouldn’t go ahead gets squashed - but I don’t see that here.

the concern you have that the regulators have said it not being suitable for high risk makes sense. Why would you test somebody that is already being treated for DKD? The test is to be used to rule out (NPV) patients with low risk which would help heaps of people? That’s been the thesis this whole time? The concerns around study methodology and relevance to Australian population is fair enough. I’m hoping PIQ over the past 20 years has some studies that can bolster their application. Otherwise like you said, get some runs on the board in the US first and then have another crack.