Horseb4CarT finally some one on this board besides myself can see the forest thru the trees. Additional data will in most cases with cancer trials create further FDA questions, thereby having to kick the can further down the road, resulting in additional delays to approval.IMO
In theory it's irrelevant from an approval perspective as both control and treatment arm have same inclusion/exclusion criteria. If the result is borderline stat sig however this is where i could see it might come in to play so yes it's still worth measuring regarding the current trial..since we have so few controls now due to cross over things could be tight so it's prudent.
-If the result is borderline pass then it potentially could show that it wasn't due to just randomly extra assigned idh+ in the control group. -If it's borderine fail then if they happen to see more idh+ in control relative to treatment then they might still get approved anyway.
On top of that though i think looking at the idh mutation status should be useful in directing future trials and just generally understanding the disease.