It's really hard to say. But a control group will be required if it's going to be like any of the other confirmatory trials.
Granted, some of those randomized confirmatory trials have been moving things into a different disease setting. Like tucatinib-trastuzumab in HER2-positive CRC. Approval in progressive disease, confirmatory trial in frontline therapy.
So there is room not to just redo the work to confirm, but to move to expand the indications as part of confirmation. Possibly add in the grade 3 glioma or something, I don't know.
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