Just to add to the above @sheedos, & I know you have been around...

Just to add to the above @sheedos, & I know you have been around a very long time here, even though you rarely post, so I’m happy to discuss.

This was of interest to me:


”Upcoming FDA Regulatory approval process should be accelerated by using the Janssen/PromarkerD data.”


PIQ had announced some time ago, we would seek FDA approval for the test in July 2020.

After we had already received approval in the EU with CE mark awarded for both test forms & the online hub for interpretation, it was a bit like: why are we waiting with the FDA application when we have already sought the CPT billing code for the USA ages ago? So it’s all making sense now.

I think the above quoted statement from the Investor Presentation is the answer to that question, which we did suspect once we knew Janssen trial results would be presented in June.

So as @katy had said, we may be seeing some really important news soon (as in potentially a CDx in collaboration with Janssen on submission to the FDA for PromarkerD), once results are out on the 13 June.

I could be completely wrong here & just sharing my thoughts.

Another thought that crossed my mind is that we are due to come out of TH on Wed 10 June with a clarification from the company as to some thing/s in the Investor Presentation put out prior to Pause in Trading & TH.

If the ASX is concerned that positive results were possibly implied without the ability to ANN them due to a US Conference embargo, they may keep us in VS until the Janssen collaboration trial results are announced on the 13/6, or the 14/6 if that is the US date, I’m not up on time differences, I should probably look.

If the ASX had not scrutinised the Investor Presentation properly prior to allowing that to be published on the ASX platform & then that has caused a headache for PIQ, I really don’t know, but it was brought up by Wazza it maybe was a compliance issue & should have been TH prior to putting it out.

It appeared to all be common knowledge to LT investors, but as @katy said, that had a lot to do with us “joining the dots”. So maybe not so much common knowledge unless you DYOR.

This isn’t a bother to me if this happens, holding long term, & our results turn out to be great; then something comes of this materially around the same time for PIQ.

I guess you wouldn’t be happy if you were attempting to buy in pre-announcement though.

Again just my thoughts, please DYOR.