I do not disagree. I just disagree that it is a "requirement" of the regulator. Obviously one would prefer it be the first set-up if at all possible. That seems unlikely given the company's current set-up. But as I have said, I believe it would expedite everything if they get it approved before marketing approval and it will be the most efficient.
No, I'm quite certain regulators were never going to absolutely insist, so long as they have a workable plan and so long as the pricing fits the expected budget. In fact, for Car-T, they were approved and just got a NICE approval for more patients and they still manufacture by the same manual, extremely expensive means that they did at approval. There is not special requirement for DCVax-L. The issue for the company is being the most efficient and getting it launched in the fastest, best way possible and as I have said before, I believe they go through somewhat lesser burdens if they do get the equipment for an improvement in manufacturing approved for usage before approval. I do not think they need to be set-up before approval for all of their manufacturing or that would be another year or more of delay. They have Sawston set-up already, they can and have plans to add clean rooms. They are signing CRL up for North America, as a fall-back for rapid expansion of production. I think they will expedite approval, not delay further.
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