She is seeing from the article that PFS, the original primary endpoint, was a little worse in the patients originally assigned to DCVAX, but this is known to be an artifact of the immune response to DCVAX. Because of this, the endpoints were changed to OS which necessitated a change in the plan of analysis. Good methodological reasons to do so and the company used a very sophisticated approach to analyzing the OS data against historic controls that is consistent with FDA guidelines, especially for an orphan condition like GBM. Given its orphan status, no toxicity (very safe) and signs of a positive response to DCVAX even in recurrent GBM (i.e., benefits outweigh the costs), I see no reason why this won't get approved. The FDA mandate for orphan conditions is to get new treatments that might work out there available to patients.
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