Yes, part of a phase III is having a drug be better than it's predecessors. For example Lets say Roche has chemo drug used for melanoma. 1. We are best in class for response rates 2. We have 0 SAE which is very uncommon for what we are fighting. So even if we did not ramp up our phase IIB with a PD-1 to make results even more enhanced (fingers crossed) IMO we would be approved for IL-12 electroporation alone.As for INO they target vaccine based disease which we can not.ONCS has the patents on itertumoral electroporation. So no one in the world can use IL-12 and electroporation into a tumor. It has nothing to do with INO if we get approved nor denied.
Think Pivotal Phase2B Combo NOT PhaseIII. $ONCS has all the horses to do a successful Pivotal Phase2B and get BLA Commercial approval. Dr. Pierce CSO knows exactly what to do in discussions with the FDA for Phase2B Protocol!