I don’t know if the EMA takes around the same timeframe as FDA?, that is approximately 6 months. This licence extension application for Invokana in EU was announced by Janssen in August 2019. I can’t see that not happening with FDA approval already granted on the back of CREDENCE data.
As we are all set with CE approval for PromarkerD in the EU, I guess potentially things could move forward there first as a CDx, however the test is already licensed & being used as a stand alone test regardless for DKD, and income trickling in already from the last quarterly (posted by @brahms & @Eqz on another thread, thanks guys).
I can see this snowballing in the near future.
Volumes of research coming out now on CKD/DKD & ESRD globally & how to address this problem. I think PromarkerD holds part of that key in early detection & the potential now to treat it before ESRD.
GLTAH
PIQ Price at posting:
32.5¢ Sentiment: Buy Disclosure: Held
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