In response to @pfeifer1982 "It started off with a trial of 54...

In response to @pfeifer1982

"It started off with a trial of 54 patients , next step was selecting the data from 25 patients and artificially create a control group based, which brought it back to (25+27=) 52 patients. Problem there was, that these 25 patients could have received lots from more than one donor which could be a confounding factor as even one ODAC presented slide showed differences in INFgamma levels between three different donors. And SI has been questioned on this slide during ODAC but shifted the focus to TNFalpha straight away."

54 patients, yes. Why the control? We have other patients from the EAP protocol that would validate the findings of this study. Those not in the study would have been patients not having samples taken around 28 days . Comfounding factor are a fact of any study. The way the data is handled by the investigating team would naturally be questioned. Some may have been censored.
How could the investigating team go from 54 patients and censor that group down to just eleven that just happened to be 1 patient per lot used in 001? The chances of this ? 1 in a million.