north, there is no certainty in my post as I say that PPHM could file for a BLA. I am not saying they will, just that all they need is available and of course provided Bavi performed as expected in the 77 look Bavi arm patients (but that is wht they told us).
So yes, PPHM will have to show that the CTRL arm outperformed by interference of Opdivo/Keytruda or other 3rd ln treatments not available as Bavi started.
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