And by extension of your point, possibly they are hoping that the Overall Survival endpoint produces a positive result. However, this OS endpoint is being confounded because of the crossover option. The result is not many people are left in the placebo arm who haven't crossed over, and likely not enough to have any statistical power. I suspect when Linda L said they were comparing early DCVAX to late DCVAX she was cuing on what the DMC was doing (she doesn't know the analysis any other way other than when it is being done, so there is definitely an analysis going on). The only question is whether the FDA will accept this late versus early comparison for approval, or require a new study with the OS endpoint (which would be why Bosch emphasized that OS was the gold standard)
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