Also, with regard to Roger Stupp, I privately made this set of points to another poster Nick, who has the very excellent post on the knowwhatyouhold.com site on this very topic.
This is ALL IMHO:
Since the Stupp Protocol established the Standard of Care (“SOC”) for the industry, and NWBO needs a placebo arm that is consistent with the Standard of Care, Stupp, being the father of the Standard of Care, now joining to advise and consult not only makes sense, it is extremely powerful in significiance in terms of establishing NWBO’s credibility with the FDA, for this trial, that the synthetic placebo arm they have created is appropriately and correctly constructed, most likely with the help, advice and guidance of Dr. Stupp himself. It’s incredibly significant as we already have a good idea that the blinded data including the original placebo patients was (IMHO) outstanding. The ONLY thing that was at all worrisome, maybe, was 1) that the FDA was really on board openly and probably on the external data approach (there are multiple, consistent and strong indications that that is the case and that it is in the direction the various agencies want to head); and 2) that NWBO could construct that external data based synthetic placebo such that it was accurately consistent with what would be a meaningful and statistically relevant synthetic standard of care based upon the Stupp Protocol. Now with Dr. Stupp likely literally advising on that part of an equation that MIGHT have seemed uncertain to some, it seems unlikely to me that that particular item would still be a significant worry. In my mind that is game… now we are waiting on the TLD as the “set” and the regulators to call the “match”. But the case looks stronger and stronger every day! Again, just my personal opinion and judgment, and everyone should do their own due diligence.
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