Hi meg,
A couple of points. I agree that interim IIb results are not going to give us a statistically significant result. That is the job of the canvas trial.
However, the pfs in those in 1st remission, which replicates the cohort in the canvas trial, we would hope to see a large effect size. What I mean here is, we would hope to see a difference in pfs that is clinically relevant (40 odd days isn't really that much), and that can be statistically significant in the phase III trial. That is where my concern is.
I agree OS will be very important, and naturally we can't have that data yet.
If you are in 1st remission, and progress, that means you return to conventional therapy. While they aren't kicked out, they aren't necessarily 2nd remission patients. They can still continue on Cvac I guess and see if it helps, but it would in now way be a primary endpoint.
The data released is definitely not giving us the full story...What I can't do is figure out if that is good or bad...
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