P3 OS is relative to the ECA that was contrived when the trial was virtually complete. Several of the trials included in the ECA had screening criteria allowed a biopsy, not the complete resection required for the NWBO trial. Biopsy's have much lower likelihood of death than a full resection. It's why FDA is accepting the P3 results -- the ECA wasn't prepared BEFORE the trial and didn't meet FDA requirements.
What's comical is Dr. Liau used the excuse that PFS metric shouldn't be used, but her protocol for the UCLA/SPORE trial had a primary endpoint of, wait for it....
PFS!!!!! Wow, talk about lack of credibility.
FDA won't approve DCVax-L with a dubious clinical trial.
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