Hi Dyeman,
I think also while seperate trials, DKD & FSGS under the umbrella of CKD; these trials were designed to be synergistic for data analysis, same dose of Ibersartan (SOC) and same dose of DMX-200 240mg daily (120mg BD). Although the treatment period for FSGS was longer 16 weeks vs 12 weeks in DKD, although same crossover trial design with each patient being their own placebo.
We have a bit to wait on here with post hoc analysis in both trials & I absolutely agree, ASX Disclosure obligations for topline results. You are an experienced
biotech investor @dyeman & will appreciate as well, this won’t pop up on a topline result ANN. History repeating itself.
I saw a post earlier regarding trial design & yes that has been posted multiple times here, as I have posted trial inclusion/exclusion & full trial information so many times on this board, you almost feel like you have dementia repeating yourself.
If investors don’t read this information, well what can you do?
@jsetio a good place to start is clinical trials.gov (USA site & there are 2 just for Australia & NZ, but generally all are on the USA site). I’d be questioning otherwise & the trial design was sound. Quadruple blinded through a CRO & one that is used by big Pharma (IQVIA). Welcome to DXB btw .
I think it’s a very easy to say in retrospect, that we should have only been looking at sicker patients with DKD. No, this needed to be investigated, (an investigational trial) & with a sound trial design where they are able to look at all these factors that may have affected OVERALL results. We had top Nephrologists in Australia designing this trial & Internationally, who are highly regarded both in their clinical area & also in international research in kidney disease, so that’s a bit ‘Rich’ coming from random HC posters!
I still strongly believe that increasing recruitment numbers in DKD from 40 to 46 on recruitment, especially during a COVID-19 pandemic when most clinical trials not deemed to be essential to LOS (long term survival) were in fact, shut down.
We had exactly 40 patients eligible for statistical analysis on DKD. We now have a better idea of exactly where these cut-off points will work in treatment & just to say, also there are only 25 dots on the figure in the investor presentation from 2b trial, there should be 26 from the legend. We are not used to this kind of stuff from Dimerix. This tells me they were in a hurry. I also think the ASX made them modify their ANN, they are usually very good with punctuation & a flowing explanation of results.
I would also encourage any new investors here to go back over older ANNs & to check clinical trial sites for themselves. Including preceding trial results.
Still feeling optimistic, the market doesn’t get it right all of the time.
They haven’t done their homework.
GLTAH
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Ann: Positive Top-Line Results in DKD Phase 2 Clinical Study, page-242
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