The difference between DCVax Direct and DCVax-L is the mode of administration and that one is to treat a tumor in situ, and the other to create after exposing the patient’s cells to a lysate made from an extracted tumor. I expect the big approval will come when they identify and get approved the DCVax platform, both L and Direct for biomarkers.
Times have changed since that original trial began and I think we will continue to see change that accelerated approval for these kinds of platforms, based on new standards basically created for the 21st Century Cures Act. Keytruda has one of those generalized approvals, and also seeks to expand it, sometimes with success and sometimes not. But these are more rapidly expanding opportunities than past experience would suggest, in my opinion. I am also not sure that predictions as to interest of big pharmaceutical companies is accurate. Successful data could turn the calculus of many companies upside down, in my opinion.
I think, because the industry has been in denial in this trial and had a huge buzz for a far more complex, dangerous and difficult to manufacture treatment, CAR-T, smart executives and far sighted ones will realize that DCVax is actually the real deal. A true immune therapy that has likely very broad application, substantial power, and can be manufactured and marketed at a reasonable cost with low side effects.
The treatment hits a golden set of factors and it likely also makes their drugs more effective, potentially against cancers that currently they cannot address.
So I am skeptical that if this proves successful, everyone will still be sitting on their hands pretending it does not exist when there are already indicia that Merck has been sniffing around. No, I think mothers in the industry will have, or at least should have, an immense sense of urgency to get in there - while they still can.
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