Ann: PIQ market update, page-29

Hi Bella,

Yes, I agree. From the latest update PIQ had not yet completed testing and analysis of Janssen clinical trial, but were close to that, which PIQ have been doing throughout 2019.

There was mention there possibly could be another phase. I think they were also looking at whether PromarkerD could predict cardiovascular disease in diabetes, the second indication Invokana was also approved for by the FDA.

There were 2 very large international trials in recent years on Invokana. 1. CREDENCE study in renal outcomes, which also showed efficacy on CV outcomes & 2. CANVAS study, which was on cardiovascular outcomes.

Yes, we know that the drug was approved on 1/10/19 and while this seems like ages ago (probably due to our anticipation of news) it’s not even been a month.

For a companion or complimentary diagnostic, there has to be evidence & justification of the test’s usefulness. While we know it works & we have independent validation for this as a stand alone test, the Janssen data is vital to Promarker D for the above, & you can’t make that happen overnight.

I truly believe this is what we are waiting on & from a recent update, PIQ were getting close to completion + or - the need for another phase (I hope not). I think the re-hashed investor presentation was put out (with a few minor changes, because there was some) as roadshowing, & investors need to be updated also, as pointed out by the 2 George’s.

When the trial sample analysis is completed & Janssen have all that data, that is when we will receive some news. Hence my comment about the fully baked pie.

GLTAH