Gary,
Here's my layman's thinking,
- OS is gold standard. Meeting the primary and first secondary endpoints is for NWBO to get what it wants, regulatory approval to market DCVax-L for the indications and labels of rGBM and ndGBM. (Slam dunk)
- Given above, the next 2 cPFS and PFS endpoints maybe serve a different purpose. Maybe they are to bridge the change in SOC, a way to validate for the patient, the change from how SOC efficacy is measured today (measuring tumor shrinkage) to the future way of DCVax and immunotherapies where it is a healthy, long process of managing disease (initial tumor size slightly increasing is good, systemic response, immune memory, long tail survival, equals cure).
I think that all the endpoints will need to be evaluated because they are part of the official SAP, but I think they stand independently, each can succeed or fail on their own merits. Why US website only has the 2 main endpoints, don't know but my gut says there is a reason to be revealed, and all 6 will eventually show up.
I agree on the UCLA combination trials using DCVax as the SOC and Keytruda as the add-on being tested, leads in the direction of doctors using DCVax off-label more and without chemo / radiation.
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