But DNDN doesn not need to show stat sig OS in 02B.
The BLA is based on stats sig OS in 01, with other supporting data (mainly OS in 02B and TTP in 01). To be supportative the data just needs to show in some way "logic" that single trial data is sound.
With this as a goal, putting 02B data into the 01 Cox model makes complete sence. If 01 was fluky, the the Cox model applied to 02B would not work out well.
This is not an attempt to make 02B OS stat sig (if they could do that, they could file based on 2 P3s and we would have no debate).
But the Cox analysis nails 02B as agreeing with 01. And that is the goal of supportative evidence.
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