It also means that the FDA decides that people will die for administrative/procedural reasons.
You cannot get the BETTER drug that makes you survive longer then the well known survival time established over decades for Docetaxel because an occasional outperforming in the SUNRISE trial and under performing in the Opdivo trial of the control arm occurred.
It also shows in that case that people SHOULD NOT participate in Bristol MQ Opdivo trials because in their control arms you die sooner that the historical studies if you end up in the control arm.
Peregrine Pharmaceuticals the Microsoft of Biotechnology! All In My Opinion. I am not advising anything, nor accusing anyone.