That question has been answered so many times it should be ignored, pseudoprogression, a good thing, could not be differentiated from progression, a bad thing.  It's as simple as that, when you can't properly diagnose progression you can't keep it as a primary goal in a trial.

 

I believe that when the trial was halted, all agreed that OS would be the ultimate goal, it took a great deal of time to reach complete agreement with all four regulators in establishing the new SAP, but once it was done, it was the regulators in the U.K. and Europe who changed their Clinical Trials to reorganize the goals.

 

Gary