Thanks for the confirmation article in regards to the EMA accepting advice to extend Invokana’s indication in the EU for DKD. This was news a few weeks ago on advice after review to the EMA & LTH have been aware of this application from last year. I don’t think it’s any surprise, just going through the motions.
With CE Mark in the EU, CLIA approved lab, this could be very meaningful in regards to PIQ & PromarkerD There has already been a lot of research done recently on detecting CKD/DKD early & the deficits in current clinical practice in screening, diagnosis & current recommendations in research (recent posts), including Mundipharma (EU) & Napp Pharmaceutical (UK) sponsored research. Both are distributors for Invokana.
I think with recent validation on Janssen’s CANVAS (Invokana) trial ~3000 patients internationally, it all definately ties in nicely for PromarkerD.
I have always thought we were waiting on certain inflection points with Janssen. When we didn’t get immediate news from the Diabetes Scientific sessions in the USA on some kind of deal, this didn’t bother me too much & especially going into a second phase of research with PromarkerD on post market licence for Invokana in new indications (DKD/CKD & CVD).
Life has been busy, HC needs a break sometimes, but these points are important for PIQ. As for silent accumulation, probably yes.
GLTAH
PIQ Price at posting:
42.5¢ Sentiment: Buy Disclosure: Held
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