Hi Silsol,
I’m not sure (re priority application with FDA) but they usually do announce these things & in Pharma news, as it’s pertinent to their own shareholders. I was also expecting January 2020, so as your article stated, it could be sooner. However, there is also a black box warning on this drug for Fournier’s Gangrene. It’s a rare condition, however recent research has found an increased occurrence in patients on SGLT2 drugs. We have been discussing this on DXB board, so maybe read there also.
After reading the article I posted on the weekend, you really can see benefit for patients, medical practitioners planning care & insurance companies saving huge health dollars on ESKD & expensive costs in Dialysis & Kidney transplantation. Something like 49% of patients had CKD (DKD) without a formal diagnosis, even though analysis of lab results indicated renal damage.
I think what the potential of PromarkerD is, is that it will create a red flag for at risk patients, up to 4 years prior to changes in blood results in standard testing, which can only indicate kidney damage is already occurring. This can also give Drs indication on choices of medication & also possibly some to avoid taking regularly (ie NSAIDs such as Ibuprofen that some people pop like lollies), also lifestyle changes & an increased frequency of testing.
We have been talking about diabetes, the risks for CKD/DKD, the enormous health costs of ESKD both to Governments & private health insurance since I’ve been invested here, & now Janssen have pulled hard evidence with a retrospective study of data for 123,000 patients from a claims database & compared lab results. So I was pretty happy with this, as it also will be of benefit for PIQ & reasons to utilise PromarkerD in a growing global epidemic.
There is no way a small biotech would have the resources to conduct such a huge study, but I believe it will add benefit to justify predictive testing & the small cost vs huge costs in the consequence of missing early stage diagnosis & ESKD.
(20min delay)