When sample size gets even smaller, it becomes even more tricky to interpret. For example, if ultra HG N=3 for 011 arm, N=0 for IC arm, 1 out of 3, 33% ORR, are you going to conclude ultra HG status doesn't make any difference? I wouldn't. Most likely this is what data would show.
When they conduct ph3 trial, they are going to have to open international sites to speed up patient enrollment. Current trial is conducted solely in US.
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