The MHRA decision takes as long as it takes. You can ATTEMPT to read meaning into the length of time that the application has been in the hands of MHRA all you want. A decision has not yet been announced. You don't know why it has taken this long and neither do I.
I offer these thoughts.
What NWBO is doing is new to the system. We can see the system adjusting to the new way of doing things by the new set of regulations that have come out. Bureaucracies move slowly when confronted with things outside their experience. That seems to be the case with NWBO.
There are many stakeholders in the MHRA system, cancer treatment systems, drug production systems and regulations that will be willing to challenge ANY decision that MHRA makes in relation to NWBO application.
MHRA has to get this right and to be able to defend its actions against all of the stakeholders both those that want DCVAX-L approved and those that don't.
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