Hi AJC,
I wouldn’t discount things occurring prior to completion of Ph3 in FSGS. I think that
@dyeman brought attention to interim analysis in Ph3 Orphan IND status with the FDA.
We are waiting on news with COVID & I don’t think that Dimerix would cut their nose off to spite their face right now without available data.
Discussions have been continuing. Nor do I think it is wise to discount DKD, particularly that patients on SGLT2i were included on the Ph2 trial with baseline ARB also, & added benefit shown in results. There were patients on that trial with lower levels of albuminuria & the way it looked at the time with the crossover design & statistical analysis, was that it was a fail in less sick patients.
The interesting thing is that patients have reverted to normo-albuminuria on treatment, & that is a phenomena with SGLT2i trials as well. So that is a good thing, it can fluctuate in early stages on treatment, but DKD is a progressive disease. You want to catch that one early. It’s looking like DKD is reversible in very early stage.
A lot out in the last few years with SGLT2i & Finerenone being approved. Of course post market studies continue & this class of drugs plus ARB is now also a big focus in preventing major cardiac events also & International KDIGO guidelines updated. Cardio-Renal is all connected, especially with Type 2 DM. I try to keep up! Maybe some reading for you, if you are interested.
Be prepared to be blown away with the magnitude of clinical research in this space & also familiar names popping up that are Lead Investigators & Author on Big Pharma trials, that are either on our Medical Advisory Board or Lead Investigator on current trials.
This is why I get frustrated with a couple of Muppets posting on this board. The extent is to criticise the CEO & BOD, with what kind of understanding of anything else in long IP or our pipeline? What’s happening globally in multiple indications…Nothing.
I invested here in Ph1/2A. I’m still here in Ph3. I don’t believe that was a wrong decision, when you look at it in Biotech terms. Still the same criticisms & rubbishing of the Company. Nothing new lol. Same old BS.
GLTAH
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