Just to add to the above, we are incredibly fortunate to have the Janssen Collaboration for validation of PromarkerD.
If we had to do this on our own, do you know how much this would cost & how long it would take for a >3000 patient clinical trial? If you look at clinical trials for tests in various indications, even in a ~1000 patient trial for validation, this could take 3-4years and 10s of millions of $$. Also a big issue is gaining access to trial patients & getting trial sites onboard, so collaborations with big Pharma are incredibly useful in this respect, not to mention the necessity of ethnic diversity on clinical trials & the risk for kidney disease globally. There are known genetic and racial risk factors for diabetes & DKD.
We’ve had positive results in DKD patients with CVD risks (so sicker patients than the community diabetes validation trial & a mean age in the mid 60s from memory, so higher risk for CVD/DKD). These results were independently analysed & validated by Janssen (co-authored presentation & Peer reviewed published paper). Now in Ph2 on the back of these results.
Bring it on PIQ...Doing it all right.
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