If they pull the IDH-mutant patients from the treatment arm, they would need to pull the IDH-mutant patients from the external control arm they intend to use. I believe (but I'm not sure) that this data will come from other comparable and historical trials. Many of those past trials did not collect this data on patients so it would be impossible to access it. One option, though, would be to call up someone at Celldex, as well as at Optune, and ask if they'd mind handing over their patients' tissue samples so we could test them for their IDH-mutation. LOL... that ain't gonna happen.
It's good to have this information on hand as the regulators would likely want to see this information if it were available. So in anticipation of that, the company assembled it; and one would think it would be a part of the data submittal to the regulators.
If 500 of the 1400 separated this data why not go with an external control arm of 500 to analyze the data consistent with the redefinition?
I do believe that comparing the treatment arm to a larger control arm (232 to say 1300) helps with the powering. It's better if 232 patients can be proven to have lived longer than 1300 patients who didn't receive DCVax-L than to compare those same 232 patients, and show that they lived longer than 400 ECA patients.