We have a major difference in our clinical trail than Travere on top of having a very different action of mechanism.
The design of our study is also entirely different. Travere ran what is called a comparator (active arm) study compare to placebo study.
Travere results stand alone were good enough, what stuffed them over is that the comparator arm showed large and unexpected response which has negatively impacted their statistical significance...
Our study is a placebo controlled and Dimerix has been careful to design the study without a change to background therapy to minimise placebo impact on control arm...
It's not Travere only where the end points are the same, an improvement in eGFR slope is the only way as things stand now to get FDA full approval....
Of course I would love if FDA changes its position to give Travere approval on Protienuria reduction alone but I don't see it happening...
Finally, I think our P2 results were equally as impressive as Travere even though on low patient count ...
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