2-week median difference may not capture the exaggerated KM curve separation due to fast placebo arm drop-out. Similar to Panitumumab, but at least there Amgen had independent review and radiological events only. How could an independent panel review pain- something so subjective?
What are the post-approval committment - demonstrating OS in this trial or is it currently enrolling another Phase III maybe in the first-line in case the OS fails?