Chiugray,
I don't really believe that this is the case. Remember, the U.K. and Europe revised their versions of clinical trials after receiving and agreeing with NWBO's SAP, the company was surprised when it happened. I believe what NWBO posted on the U.S. Clinical Trials site is what they really believe should be the only goals that are needed for the trial. It is all about OS and they really didn't believe they needed more than the two criteria they set up for it.
I don't know if in approaching the U.K. and Europe they'll address all six of their stated goals, or perhaps discuss with them reducing to just the two goals accepted by the U.S. We know that PFS is a failure because of pseudoprogression, so the time to pseudoprogression being shorter than the control time to PFS could be viewed as a positive, if we knew for a fact that it was pseudo, but we don't.
I believe that people like Dr. Liau and Ashkan know that other therapeutics, like Keytruda, will also improve the results further, but only from Phase 1/2 data. If DCVax-L were approved today I believe they'd recommend the off label use of Keytruda, and perhaps others, to their patients. I don't know how much higher that could take the survival rates, but believe it could be to the 30% to 40% range. It should be clear that without DCVax-L it's not nearly as beneficial, but our vaccine helps to make other therapeutics more effective. Some of Dr. Liau's lectures have essentially made this point.
Gary
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