Some very good questions @Eqz and thank you very much @The Rad in advance for being our eyes & ears at the AGM for the Interstate people. I’m sure that we will receive a very well balanced view from your insights.
I have a couple to add or expand on @Eqz questions:
1. In regards to the CPT code & engagement with Payers (ie Private Health Insurers) has there been any progress on this?
2. And also in regards to question 1 is there any progress/news on licencing discussions with Tier One Pathology Laboratories in the USA? Both of these were mentioned in prior ANNs.
3. An update on Patia (Spain) (existing) and utilisation of PromarkerD ELISA test. Existing partnerships were also mentioned in a recent ANN & Eqz has already covered 2 of these.
4. Lastly, and I think very importantly, was the FDA approval postponed due to Janssen Collaboration data (I think this is the case) & will they be going straight up for the CDx for CKD/DKD or will we also need to wait for CVD results as well for this to occur for all indications for Canafliglozin and an updated timeline on this please. Some clarification on the FDA application would be good. PromarkerD can already be used in CLIA approved Labs without FDA approval.
There has been a recent one for NASH (Non-alcoholic Fatty Liver Disease) another diabetes related problem for some cases & Labcorp have scooped up GENFIT’s test to commercialise it in the USA (estimated 10 million sufferers in the USA). I think this is relevant & interesting to us here, in regards to looking at the prognostic value & number of patients who could benefit from PromarkerD in the USA.
https://www.fiercebiotech.com/medtech/labcorp-aims-to-take-genfit-s-nash-liver-diagnostic-blood-test-into-primary-care
GLTAH
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