Since Poly-iclc is already approved for use and as safe, and DCVax-L will likely be approved, IMHO, then upon approval, doctors will likely prescribe the two, and further, NWBO, or Oncovir, will have the ability to present clinical data showing substantially and really incredible results with the combination, as RWE/RWD, and that would be enough to potentially change relevant labels and to get insurance coverage designated. The MHRA has policies positively favoring RWE/RWD as all of the major agencies worldwide are trying to harmonize policies on such matters and also ECA’s.
No need to get an approval with this Application, as I have said for some time. At one time I had speculated, prior to understanding that Hiltonol had been approved, that an unapproved “adjuvant” can be included in an application. But that was not necessary, once it was clear it was a separate, approved drug, and was administered separately using an IM injection.
I never agreed that anyone had any evidence that Hiltonol was used as a “maturation agent” for DCVax-L. We in fact disagreed about this at length, based on a range of very clear evidence to the contrary including the need to do the trial and the result based on an adjuvant IM injection of poly-iclc separately to induce the stronger immune response. There was never an indication it was already in DCVax-L and speculation that ATL-DC required the IM shot but DCVax-L didn’t but that the UCLA was getting such incredible response really suggested otherwise. My argument also was that the argument otherwise would sometimes go into the wild suggestion that there were “different versions” of DCVax-L which would have been a disaster and actually would amplify AF’s lies, perhaps inadvertently, about different versions and thus false claims about patents.
Thanks for clarifying now.
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