Friday, August 26, 2016 4:22:29 PM
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.
Respect Risk. Conduct Your Own Due Diligence. Manage your assets wisely. Diversify.
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