Ann: Proteomics files US FDA 513(g) regulatory submission, page-25

I do not think we can question the FDA’s position and propriety given the challenges and workload they would be facing with the epidemic and mandates for new drugs to combat COVID. In the FDA media announcement on the IVD submission freeze specifically stated – “While we’ve never had to take such actions in prior public health emergencies, we've also never experienced a pandemic like this one.”

RE: Breakthrough device designation, I agree – the company needs to give us some information as to why this is not a pathway for PromarkerD given KidneyIntelX received it just fine. I will see if I can muster up a response from Dirk or Richard on this. Regarding FDA approval, I am sure you know but for the benefit of new investors here, the FDA approval is only required for the IVD version of the PromarkerD test kit.

The LDT Mass Spectrometry version of the test does not require FDA approval and can be commercialised in the US via CILA labs. I think it is highly unlikely we will fail FDA 510k/De Novo given the numerous clinical studies completed so far. But more importantly remember, Richard specifically called out that mass spectrometry diagnostics platforms would most likely overtake current immunoassay technology.
I do not understand how this works at a technical level, but it bodes positive in our favour for the long term/future adoption of PromarkerD, with or without FDA approval.

Here is a question we all need to ask ourselves, If LDT can be commercialized in the US without FDA approval, how is it possible 26+months have passed since the Prism Health deal was terminated and no commercialisation partner has since been secured? The only logical conclusion I can think of is a potential deal with Janssen is on the table, but pending Ph2 data.

Time and time again we have seen inpatient holders push the price down, and that is when to buy. The fundamentals are solid here, it’s just a waiting game. May the forth be with you.