I can quickly answer one comment. I meant they had probably enrolled at least 190-patients from the 216-patients US allotment. Remember each regulator has their agreed upon number. And German never screened before their true 87-allotment. When I did the modeling, and followed the money, and used my recollections of US sites adding and closing shop (active, not recruiting) and then having the one count at many of the same recruiting sites, meant that there were hardly any real sites in the US recruiting. It was scaling down in late 2014/early 2015. And sites that were being added at that point were for commercializations.
Keep in mind that my blended placebo median is very high. It essentially means 15 months for placebo cohort if this study is high MGMT methylation status. But, it may have been harder to do leukaphesis draw on the Germany patients. And if those placebo patients had lower counts (lower inclusion) before chemo-radiation then that placebo group, which is just under 1/3 of the placebo for the trial, then those patients could progression event. There is a WBC correlation with standard of care survival, and so many of these placebo patients could event before their US-UK patient peers. (I didn't check who was doing the manufacturing for Canada, expect they have the higher WBC inclusion similar to the US.) Anyway, if 1/3 of placebo is enrolled to a lax lower WBC inclusion, patients could have side-effects from chemo treatment and events could come early (tumor will grow back quicker for that group, regardless of MGMT status). And that would mean more chance to have a normal median PFS range, verses the high I had accounted for. Hopefully that makes sense. When I used the mPFS scenario, I was trying to say "worse case scenario" the vaccine may need to prove an extension of benefit starting from a mPFS of 12 months. ? > 12 mPFS for Placebo. Remember data will be stratified by sites. I happen to think that the vaccine will show a wider improvement in the lower inclusion WBC counts. A vaccine patient in that jurisdiction will not need to be pulled off therapy due to "health" decline. They will get an infusion of their own cells and so they have higher chance of staying on chemotherapy too.
Okay, my thought on that. Now I have to analyze the rest of what you wrote to see if I get what you're trying to say and ask. Hopefully I got the first part correct....
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