The main reason I believe it will be approved on its own (the trial did not test it in combination with checkpoints etc.) is it’s amazingly benign side effects profile. Even if it only helps a subset of patients and on average adds “only” 3 months to OS, there is no cost associated with it. This is in contradistinction with other treatments that have a negative side effects profile. At minimum I would expect a conditional approval pending completion of a phase IV trial (which is de facto equivalent to a full approval).
I agree that the potential of dcvax when added to other treatments is insane but unfortunately it would be highly speculative to bank on that in the near future.
The question that I think we need to answer is why are 27 modules being prepared for submission. That seems excessive for one drug in one jurisdiction. I have read the previous theories but they remain speculative.
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