At overall level it failed - SP Tanked and they are now looking at sub- group which they think may be right target. However that means FDA consultation, new trial design and full trial - adds 2+ years. SP becomes dead
It shows that, for the whole sample, there was signal of slight improvement over SOC but not stat sig, and that for some subgroups, there was potentially reliable signal worth exploring.
I dont see how 2 out of 21 patients improving and stabilize and the rest decline some faster than SOC might be stat sig.
If 2-73 would in the end only be administered and available for those 2 (Group 1 in the chart) then biomarkers and further PK is necessary yes. But over the whole group, there is no stat sig of course. The question is how big is, if this chart is confirmed in the PDD readout, this subgroup is to build a business case around.