Ann: Proteomics files US FDA 513(g) regulatory submission, page-27

Hi Green8,

Just going to repost the timeline for presentations so it’s easier for everyone:





So if you look at this, what will be presented at ADA 81st sessions in June 2021 will be Health Economics Data, so I am guessing that is from the recent studies that PIQ carried out in the USA in regards to PD.

The clinical data appears to be over the next few conferences from that & 2 major conferences, one in Europe & Australia. There are multiple others, that are related but need to look at the focus of the conference & what type of data is to be presented at the conferences.

Something people may have forgotten about, is that PIQ completed Laboratory measurements for Ph2 of the study LAST YEAR & we are waiting on analysis. This was announced in the AGM presentation which I have posted above (26/11/2021). This in >3000 patients.

What is interesting here is that Janssen had extended the study for Promarker D to November 2021 & I believe, most likely looking at Cardiac & Renal outcomes for CKD, other than DKD. However we are still presenting PD data at major conferences prior.

If you look at the table & timeline of conferences above, & you consider the regulatory approval (currently) of Canagliflozin in each jurisdiction (EU DKD/Diabetes) (USA DKD/CKD/CVD/Diabetes) then that makes sense.

ASN Kidney Week in the USA will be the place to present DKD/CKD/CVD data (where the drug is currently approved for all of these indications).

I don’t know about you guys & girls but I find the current dump on shares quite ridiculous over something that is beyond our control with the FDA having to take an unprecedented step to modify their caseload of new applications with COVID-19. Sure all of us are frustrated, but it’s not going to change our timeline (and particularly in the USA for CKD/CVD as well as DKD, that will be the big factor in a CDx at least in the USA, as it covers all the bases pretty much of what diabetic patients are at risk for, prognostic (4 years prior to diagnosis of DKD) AND predictive of decline in Renal Function of DKD patients (Ph1 Janssen & other studies, Peer Reviewed). I think when you feel that way, it’s better to look back, over all the evidence you have, take a step & take a good hard look at it. Because that’s what the FDA will be looking at, not our SP or impatient SH.

The Boogey Man is not out to get us, COVID-19 is already doing a really great job of that & has a lot to do with viral variants, keeping on top of vaccine development, safety & current treatments for COVID-19, tests, medical equipment & all the dodgy stuff in between Disallowed salesmen are plugging as a ‘cure’ that need addressing for public safety, plus everything else the do anyway as the ‘Food & Drug Administration’ in the USA.

GLTAH