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Tuesday, April 12, 2016 7:05:54 PM
Thanks for your response but 2 major differences of opinion here and they don't have anything to do with NWBO public relations issues which they definately need to address. This is all about the science which is what they are good at.
Method A and method B were not originally expected to show much of a distinction. When they began to notice that there did seem to be a distinction (probably analysis of similar patient characteristics and cancer type to different treatment and not just because of improved performance status of those later enrollees since Drs. Subbiah and Bosch are better researchers than that) they came to the conclusion that method B would be used exclusively in Phase 2. They have yet to correct that statement. I can think of several other reasons that could be behind the lack of mention of method A or B now and part of it, as a minimum, may have to do with presenting more favorable data for Phase 2 vs the entire Phase 1 group. By the way, they changed to better ECOG scores because patients were being delayed immediate access to treatments and eventing before the treatment ever had a chance to work. You need to keep in mind that you used 3 "if" equivalent suppositions to come to your conclusion on this point. Based on these suppositions you stated "So trying to draw a comparison between the two as equal groups would be inaccurate." Your "ifs" would be easily resolved by sound scientific practice which Dr. Subbiah and Bosch are paid well to do for good reason and that has nothing to do with public relations either.
As far as your guess as to method A vs method B activation, I can almost 100% tell you that this can not be the case based on expected biological activity. The type of activation you suggest will not in and of itself create the type of necrosis reported from Phase 1. Go back and look at other DC direct injection studies and you will not find this happening anywhere close to the extent found in this study. There is a different MO going on here and I have given hints as to what I believe that is and so has Dr. Prins. Again these hints have nothing to do with public relations.
I know you believe you gave a good rational for treating all A and then all B patients by group. Based on what I know combined with what I strongly suspect about Direct maturation,however, switching back and forth would not be a major chore or expense and I strongly suspect they did just this to match up patient cancer type and performance characteristics as best they could and not because of public relations.
On a final note, survival, while hoped for, was not to be expected in as many patients as originally hoped for mainly because of spacing, dosing level and duration of treatments but also because of the potential differences in effect between methods used. These issues will all be addressed in the Phase 2. I don't know if the public relations issues will be. Lol. Best wishes.
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