There is a lot of supplementary data (including safety & Adverse side effects) that is not in the body of the article. I had posted this for discussion over the weekend on DXB board, but finding now I can only read the shortened version of the article without all supplementary data without signing up for 3 free articles a month from NEJM (which I will do).
The Credence trial was 4401, not 700,000 (sounds like a meta analysis) patients that were randomised & the drop out rate was quite large for various reasons prior to the end of the trial including adverse events (whether related to the trial drug or not, both in the trial drug & placebo arm). There were 2200 in the trial drug arm (Invokana) to start with.
I would advise investors to read this for themselves if interested. I think it’s of far more interest to DXB investors as we are going through clinical trials utilising PromarkerD in DKD trials.
So @brahms yes PIQ have collaborated with a company that in smaller trials leading up to Ph2b (current) there have been no safety issues, but Diabetics are at greater risk anyway for amputation. I hope that both concomitant trials are positive, both for FSGS (Rare Disease Status with FDA & also DKD, which is endemic). The latest trial data had found that amputation was greater in Invokana patients, but the difference between Trial drug & placebo was clinically insignificant. The numbers are in supplementary material within clinical trial literature.
I’ll leave that up to the FDA to decide & the risks of SLGT2 drugs & risk vs benefit for individual patients & subgroups & Definately methods need to be scrutinised.
I think our main concern here is how PromarkerD is helping to predict kidney disease in diabetes, is it also helpful in predicting heart disease in diabetics (which was a possible goal for PIQ)?, how will this collaboration help to shape the future of CDx both in clinical trials & also in patient treatment as a gold standard predictive test instead of the “here & now scenario” of ACI & eGFR once the damage is already occurring & becoming evident on blood results. There are other SLGT2 drugs on market & in trials also looking for the same added indications. Best to be up to date for all of this & requires a lot of reading. GLTAH
Disclosure: Invested both in PIQ & DXB. Not cross promotion, but discussion really does affect both stocks.
Best Wishes.
PIQ Price at posting:
28.0¢ Sentiment: Buy Disclosure: Held
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