If Pazdur writes the SPA based upon a MSKCC-designed protocol, and this trial WILL have a SPA using a protocol designed by MSKCC, ODAC will follow along. There are few things in life that are certain where Pazdur and ODAC are involved, but that would be one of them.
While I would certainly strongly agree that Pazdur is the dog, ODAC the tail I do nonetheless think it would be, at best, difficult to get through ODAC if bone pain relief was essentially identical between XL184 arm and comparator arm but there was some huge difference in a composite endpoint such as I described earlier. And if the comparator actually had better pain relief ... .
PS I find it amazing that Scher carries the weight he does. Not just because of his short sighted and self serving Provenge behavior, but looking at the trials he has been involved with. He is plodding at best. How in the world did he get where he is?