Hi No Vice,
A really great post & very balanced. There are some recent catalysts that have come into play now for treatments.
When you referred to current predictive DKD tests in the market, there are actually NONE that are FDA approved & PromarkerD & a Korean urine test appear to be the only ones with approval in the EU with CE Mark.
As far as trials are concerned & regulatory approval, Renaltyx is a little way behind in regulatory approval, but a huge MC, the test focus is a little different and also the IP being both biomarkers & dependent on AI (including EMR, which is not available everywhere, including community). RenalytixAI test is being trialled in the USA & this test is potentially particularly helpful for ESKD prognosis. Like PIQ PromarkerD , RenalytixAI is able to be processed through CLIA approved labs in the USA without FDA approval. So why are we holding off? (J&J?)
Think about it. RenalytixAI has a collaboration with AstraZeneca now also, like we started in 2018. It might look all glossy at the moment for that Co, but clinical trials of this magnitude with Big Pharma have already taken almost 2 years for us & we are nearing the head of this. Ph1 completed successfully (test validation in patients with CKD/CVD risk, so comorbidity). We should almost be at completion of Ph2 for CKD/DKD.
What PromarkerD will be helpful for is Predicting DKD/CKD prior to changes in bloods & urinalysis on standardised testing & over various stages of DKD/CKD. KDIGO should be used for reference as an International Standard (2020) for screening of DKD.
What we are looking at now is is prediction in treatment outcomes with Canafliglozin & that will be important for CDx. Forxiga has just been approved priority application to licence in the USA & so now the race is on. Canafliglozin also had an earlier black box warning for risk of lower limb amputation removed by the FDA recently.
All SGLT2 class in the large Big Pharma trials (including the ones we are analysing blood samples from retrospectively) all appear to have similar positive outcomes for CKD/DKD & CVD. Results due FY 2020 for Ph2 with our trial with Janssen CKD/DKD. Also in addition whether treatment outcomes In diabetic cardiovascular disease can also be predicted by PromarkerD (CVD).
Then we also have analytic revenue & an extremely positive earlier stage pipeline for diagnostics in common diseases with an unmet clinical need, one identified by WHO & the Bill & Melinda Gates Foundation as a priority disease in Third World Countries (yes these gastrointestinal diseases still proliferate although it’s all about COVID-19 now. If you are already struggling with a chronic infection & burden on the Immune system, potentially malnutrition & COVID-19 infection, then yes you may see more young people dying from this virus & a lack of medical care related to socio-economics (ie Poverty). India is struggling, while Trump got a polyclonal antibody infusion & his “Immune Glow” & how many deaths in the World & US from COVID during this time? He got treatment early including polyclonal antibodies. This is the difference. This isn’t available to everyone, the drug costs are high (Not Dex)...but this should set a new standard as there are already predictive bio markers for COVID-19 for severe disease, research ongoing including PIQ.
Is PIQ anywhere near the MC it should be? I highly doubt it, but one thing is for sure, at some point it will be & it’s been nice to watch this progress & yes we will be a $10 SP company I believe. It’s just not big on hype, Industry standards yes.
GLTAH
(20min delay)