That may be true sentiment, but the end product is not a highly engineered cellular product. It appears to be more about the maturity of the cells. But they seem not to have been highly manipulated with either dna or rna or with viral factors to change behavior. In the EU, biologicals that have less engineering, are treated differently as I recall, than highly engineered products.
Because DCVax-L has the exposure to the tumor lysate outside of the body, one might argue that it is a more complex process, though again, not engineered. It’s really more about processing the cells a little different and that lysate process actually makes the L product less easily automated because it is more complex. It might even be that direct and L basically are the same product through much of that processing, and that would make sense.
It might be a misnomer to think that they are different products simply because Direct is more easily automated because the key magic happens in the body.
Blood products are biological. They are also not highly engineered. Though we do separate things like platelets and other components of blood, and this product does not go to another person, it goes back to the person from whose body it was extracted.
I suspect that there are layers to the conversation with the FDA. But that some questions are not as nuanced or as complex as some may think. I think the key will be whether these products are efficacious. But the differences really, as I see it, are administration of basically of autonomous cells processed relatively lightly, by today’s standards.
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