Ann: PromarkerD latest results published in peer reviewed journal, page-11

Hi All, well that was a bit of a surprise, TH on Monday morning! I also think it’s the Janssen/PromarkerD study, the timeline we were given from the latest investor ANN ties in & there appears to be no need to TH over their latest published data recently announced: See page 11.

Janssen R&D, Current Status: “First analytical phase commenced in February and is nearing completion. Samples will then be unblinded to enable the statistical analysis which is expected to be completed by late 2019. Further sample analyses dependent on results of first phase.”

https://www.asx.com.au/asxpdf/20190830/pdf/4482hjyqg6qlxj.pdf

Not forgetting that PromarkerD was not only being used by Janssen to predict CKD in a very large diabetic trial cohort, but also potentially predicting cardiovascular disease also, so this could possibly be a part of news to be announced when out of TH. Here is the link for that ASX announcement last year:

https://www.asx.com.au/asxpdf/20181126/pdf/440mb86sdpmk7m.pdf

Also, some news on Europe & new guidelines for treatment from European Society of Cardiology (ESC) & European Association for the Study of Diabetes (EASD) for SGLT2 Inhibitor class of drugs as a first line treatment for Type 2 DM patients with risk for CKD & CV Disease:

https://www.businesswire.com/news/home/20190902005275/en/Mundipharma-Welcomes-New-Guidelines-ESCEASD-Recommending-First-Line

Some fresh news out this morning, AstraZenica’s Forxiga has been given fast track approval status by FDA for CV indications (same class of drug):

https://www.fiercepharma.com/pharma/astrazeneca-s-farxiga-nabs-fda-fast-track-after-class-effect-cardiovascular-outcomes-win

It’s almost 6 months to the day J&J (Janssen) filed their FDA application for Invokana for CKD indication (also fast track status with FDA, so 6 months instead of 10 months), so should be some news on that soon too (with PromarkerD more likely as a CDx on approval (potentially also for CV risk depending on Janssen study collaboration?), as PIQ have been hinting at all this time.

Lots happening, let’s hope our numbers are great on Wednesday when we come out of TH. GLTAH