Friday, November 15, 2019 12:29:44 PM
I agree that it doesn't impact the outcome:
1) this is split between both arms so actually it is les than 5% in each arm
2) this is more impacting the placebo arm and can work in our favor since those are normally non responsive to the existing SoC which in our case is the placebo +MMF
3) even though they are historically non responders to SoC, they could respond to VCS which is a new treatment and this is an opportunity to test it on them
4) Normally it is risky to have this type of patients in your trial since you don't know how they will respond, but I would be worried if the % was much higher (like the Abatacept trial where they consisted of more than 35% of the trial patients)
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