I was re-reading the annual report a couple of days ago with a friend and a few things came together which gave me new insights on expectations.
This may not be new information to those that were already following closely, but certainly helped clear things up for me.
The US FDA approval requires the company to be 21 CFR Part 820
compliant. Which PIQ is not.
However 21 CFR Part 820 is very closely harmonized with ISO13485. PIQ is also non compliant with this certification however, as mentioned in the annual report, they are working towards ISO13485 certification.
If they obtain ISO13485 then that's a good green tick for the FDA submission.
Remember FDA approval is only needed for the Immunoassay (IA) version of the test. The mass spectrometry LDT version of the test can still be sold in the US via CILA approved labs. Richard specifically states that the initial US roll out will be for the LDT version.
The LDT version of the test allows faster adoption in advanced markets, so this isn't necessarily a bad thing in the US market.
The other component to this, is the phase 2 study with Janssen is using the IA version of the test. In the annual report Richard mentions that the data from Phase 2 with the IA version will support the FDA submission. So this must be the reason why the FDA application has not been made yet, i.e. they are waiting for Phase 2 to wrap up so they can use that data for the FDA submission.
Another thing that I find interesting and keeping in mind I am total novice here, is the negative predictive value for PromarkerD is 98%! On a 3,000 cohort study, to me that's insanely accurate! Given that phase 2 is all about improved prognosis after treatment, this is very significant.
Here's an overview of upcoming catalyst as I seem them unfolding based on whats been announced already (not in order) -
CY20
- Janssen Phase 2 Results (focuses on if patients PromarkerD risk score decreases after treatment for DKD)
- ISO13485 certification (required for FDA submission)
- Giardia validation of prototype immunoassay
2021/Unknown
- Endometriosis clinical study (partnership)
- Further distribution/license deals of PromarkerD
- Asthma & COPD discovery results, if positive will move into POC stage
- Plant Dieback discovery results, if positive will move into POC stage
- Diabetic Retinopathy discovery results, if positive will move into POC stage
- Oxidative Stress (2-tag) - Clinical validations pending & commercial discussions.
- Licensing partnership for mass spectrometry cancer biomarker test *this is an interesting one and worth reading in the annual report.
- Validation of QIMR's biomarkers for oesophageal cancer
So with $6M in the bank and now a further $1M in tax rebate applied, could the company be any better positioned to hit everyone's $1 target?
Richard is #1 holder with a mediocre $250k salary. FY20 outflows of a mere $384k.. granted FY21 costs will increase as manufacturing costs will start hitting the sheets, but so will revenue. This is a well run business, good management, good ethics, excellent product, ahead of the competition etc etc.
Anything under 50c is excellent buying, the only thing that will dampen the party, is the ability to rollout the test during COVID lockdowns. No doubt the Italy efforts will be hampered due to the new lockdowns there.
I think FY21 will finally start bringing in some PromarkerD revenues, it may not be significant but it will start the ball rolling.
Cheers~
(20min delay)