Ann: PromarkerD US commercialisation & Promarker pipeline update, page-37

Hi Mate,

That has always been my understanding as well, up to 4-5 years before symptoms or clinical signs. I am not in anyway questioning PromarkerD, but the clinical evidence from trials that has yet to afford Regulatory Approvals & therefore commercialisation (the CLIA pathway in the USA is not ideal is it vs FDA Approval, that all went quiet). It’s been going on for a while (years) now, you can’t blame everything on COVID.

You can go back & read. Now this with KDIGO 2024 Clinical Guidelines 2024, that’s the BIG thing. I think the difference here is that studies were done that were asked for black people, minority groups & differences in eGFR, not sitting back & expecting that things will magically happen.

From the last 2 publicly available documents for Regulatory Approval guidance?

That is the last I’m going to say on this, it’s very disappointing, especially that we have a large population of Indigenous people in Australia alone with CKD/DKD & many on dialysis. That goes for Oceanic people living here too from the Pacific Islands. I feel it’s a missed opportunity.

I do wish you all well. I know it’s not easy.