That is actually not what is being said.
The Specials process takes this into account by presuming its doctors and hospitals will do much of that work, together with the patients first. Yes, it defers to them, but in this instance, everyone knows also that the purpose of this factory is to produce DCVax-L, though of course other products as well, so the unique and complex processes that would be necessary to produce a novel product would of course be reviewed, for safety and fitness, that the processes involved would deliver a safe and fit product at the end. They are not just mixing chemicals. This is a live product involving multiple different tissue and live cell inputs from specific patients. So while yes, they are certainly licensed to manufacture likely almost any cell product at this point, the reality is, they likely would not certify without taking into account the specific requirements of a facility to make the product intended for manufacture at this facility. I would find it very hard to believe there would not be extensive discussion and review of processes for that specific product and the unique issues it raises.
But as to the unlicensed product, the regulation referenced in the license is specific to that reg. And that reg addresses the unlicensed and unapproved aspect of the end products, ultimately, and indirectly DCVax-L because it has been recommended by a local doctor in consultation with their patient and likely would not be so if they were not following nationalized hospital policy with regard to such recommendations. So a lot of deference is being given to the doctors.
Now, if no doctors recommend this product, then this facility and this license were pointless to get for NWBO and Advent as its contract manufacturer. I do not think anyone anticipates that to be the case however, neither NWBO or Advent, but also likely not the regulator or the doctors in the UK who know the product. It is just that he process is incredibly nebulous and not specific.
No one is saying it is approval, but the regulator knows the purpose of the facility, they know the manufacturing process it involves and they know that it will be used to make DCVax as well as potentially other products. But they do know it will be used to make DCVax, and they likely saw the processes and procedures the company will use for that and other products.
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