OK. 1 post for today.
My take.
IMHO.
It seems that unless something way beyond the pale (in either direction) occurred, the trial should be moving toward completion.
I know the bears and longs (I'm a long) have different opinions about the previous trials, but let's put those aside for a moment.
If you substituted PFS for OS in the old Celldex trial, it might shed some perspective.
It took approximately 15 months to go from a full enrollment announcement to a 75% event announcement (of 374 in the primary group) in that trial where the median for control and treatment hovered right around 21 months for the placebo and treatment groups. (Note: Celldex only used 100% resection patients in the primary 374 group)
That was overall survival, but just consider it to be PFS for this exercise.
While NWBO is conducting reviews at 60 and 80% of 248 and final review at 248, in reality they are conducting reviews at 42.8%, 57.1% and 71.2% of 348.
If October 30, 2015 was the equivalent of an enrollment completion announcement on clinical trials.gov, we are now at 10 months beyond that point. Instead of 75% of the whole group, we only need get to 71% events.
While both sides can scream and yell about enrollment rates, etc, in this exercise, if the prior DCVax-L PFS of about 2 years is a given, we should be moving toward completion, particularly in light of the removal of longer lived early pseudoprogressives from the 348 group.
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