Onco - I agree it was not a peer-reviewed scientific presentation at ASCO, but that does not take away from the science presented. I have no idea whether these claims of tissue agnostic approvals will happen or how likely they are. However, what excites me the most about the ASCO presentation is that clearly the company and scientific advisors have been working on defining and documenting the MOA of DCVAX. Having an identified MOA will help offset the likely criticisms of the phase 3 trial design (use of external controls) during the approval process for GBM with regulatory authorities. In the absence of a MOA, it would be much easier for FDA advisors to simply claim the positive phase 3 results were the result of selection bias and differences between the DCVAX sample and prior phase 3 trials used as external controls. Now that argument is much less convincing since we can see why DCVAX should have been effective in the trial.
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