
Saturday, March 10, 2018 9:44:32 AM
So if the dosage was increased to meet the 70% efficacy in the mono trial because it might have been falling short.....
I appreciate Salt's information, thank you Salt. Hopefully he will respond to your question.
But I would think that even if the efficacy was 85%, they would increase the dose on the 15% rebounders. So, I don't know how much one can read into the dose modification vs hitting the 70%.
Now for the 70%, I would like to know if that is what the FDA is looking for to switch from investigatory (as Salt suggested) or if that goal was set because the phase 2 trail was around 70% and the want to increase that percentage?
A important note, it does not have to be 70% in the entire population. The just need to find a subset. I know in a previous CC the mentioned increasing the dose for a certain group (receptor count or something like that, I can't remember right off)... well maybe that group does not respond well and will not be included as responders. Maybe the efficacy is 90% for people with blood type O or whatever. That makes obtaining above 70% much easier and since they had around 70% for the entire population in the phase 2, I feel that have a very good chance of hitting that mark.
Primary Objective: Identify PRO 140 responders and increase responder rate above 70%

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