Ultimately, the decision will be made by the FDA. Question is what they will require to approve Multi-TAA. Usually, a prospective randomized trial is necessary, comparing the new drug too SOC. However, to run such a trial ethically, you must have equipoise, that is you can't know with certainty which treatment is better. I would assert that if we see another CR or even two in group A, it would prove Multi-TAA is synergistic with chemo, since CRs are so rare with chemo alone. Would the FDA accept this evidence. I don't know. They could grant accelerated approval and then follow more patients to be sure the CR rate holds up and that translates to OS.
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