Completely understand Aruc, it’s been a long wait. This Ph2 we are in now looking at patient outcomes on treatment with canafliglozin will be important for CDx approval for Invokana with the FDA & from recent ANNs that should be completed soon. I think this is the reason they did not go to the FDA earlier with the application for PromarkerD & the evidence from Janssen Trial Collaboration will ensure the application has the highest probability of gaining approval.
I was more frustrated TBH that things weren’t moving ahead in Europe with CE Mark approval for PromarkerD for some time (August 2020 for ELISA version). Now that Canafliglozin is approved in EU for DKD & with new clinical guidelines for screening, treating & preventing DKD, I think we will now see more interest. It’s all interconnected.
I certainly do take your points on board Aruc, in regards to revenue from test sales, you are not alone there & yes that has been frustrating (for me, it’s also the amount of people this could be benefiting & some could be so far worse off in renal function now over a ~ 2-3 year period with predictive capability), but I think the ELISA IVD is going to make this far more ACCESSIBLE as opposed to the mass spectrometry version of the test.
The test needs to be submitted & ratified by the Italian Ministry of Health (therefore will be allowed to be used in hospitals) which is expected to take ~ 1 month.
I hope that bit helps, because it’s important.
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