Hey all, with some new posters it would be good to objectively discuss what people's thoughts and expectations are of the upcoming results.
I am assuming FSGS results will arrive first and DKD slightly later, given the recruitment took a little longer in DKD.
We know that results in phase 2a were outstanding in the diabetic nephropathy cohort of patients, and I am guessing that the inclusion criteria for the phase 2b trial was carefully designed in such a way to result in similarly outstanding results, but in a much larger patient population.
For each trial, given the unmet need and the fact we are in phase 2b and orphan status has been granted, what would be deemed an outstanding result in terms of efficacy - i.e. x% reduction in proteinuria over standard of care of x% of patients with x% patients having adverse side effects? What do we need here to be ahead of Invokana, for example?
Can anyone confirm whether any FSGS patients were included in phase 2a? If not then the results from this trial could go either way? At least we have not heard of any adverse affects in either trial, which I assume would have been reported by now.
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