A question in my mind is whether an improved version of DCVax-Direct will be required to initiate a Phase 1 rather than going into a Phase 2/3. I'm of the belief that every new product must start with a Phase 1/2.
I would think that one trial could morph into another resulting ultimately into a Pivotal Phase 3 or Registrational Phase 3. I believe such a trial could be completed in under a decade, but it would take most of it.
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