Yes it’s big news for us that the CHMP has given a positive opinion for the indication of DKD for Invokana in the EU & UK. Another article below. We are just waiting on formal EU approval now & that should happen relatively quickly on this guidance. This information was given to the media by Napp Pharmaceuticals who licence & distribute Invokana in the UK. It’s Mundipharma in the EU.
PIQ already have CE approval for their IVD test kit, mass spectrometry version (in collaboration with a specialist lab, Atturos Ireland) and also for the online PromarkerD Hub for interpretation & analysis.
PIQ is an internationally accredited CLIA lab, so technically they can run tests in the USA also, prior to FDA approval. The CPT billing code that is necessary in the USA for Health insurance & Medicare payments was applied for last year (from memory). If you look at the website, new codes come out twice a year in January & July, so based on this, we should receive it next month.
The above is not what is to be presented though, the outcomes of CREDENCE were presented last year & then the FDA approval for Invokana for DKD/CVD in the USA & Canada. But as you said, it’s definitely where we “fit in”.
Since that time there has been subgroup analyses from CREDENCE presented & also for cardiovascular indication in diabetes.
This current presentation includes our very lengthy study in collaboration with Janssen utilising PromarkerD & analyses of completed CREDENCE trial samples. This was ANN’d in 2018 & a massive undertaking being such a large trial, ~3000 participants. So very excited about this & as was announced in the investor presentation, this data should lead to accelerated approval with the FDA for PromarkerD in DKD.
It’s all coming together nicely & what we have been waiting on.
GLTAH
PIQ Price at posting:
45.0¢ Sentiment: Buy Disclosure: Held
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