"The manufacturing process actually begins with the blood draw, and the entire supply chain must be tracked and traced, and must have standard procedures followed." I don't think the nay sayers here have any concept of how delicate the entire process is, from blood draw, to leukaphoresis and dendritic cell expression, on one arm of this process, and then tumor resection, freezing, transport, preparation for tumor antigen presentation, and then the combined process of pulsing the dendritic cells with the tumor antigen, to multiplying these dendritic cells in a culture medium, to final preparation of injection form vaccine. It was tedious just typing this out in a completely oversimplified format. Compare that to what happens in drug manufacturing that involves taking chemical formulations and encasing them in a pill to be swallowed, or a simple injection to be administered as is the case for most Big Pharma applications. And to think that the MHRA has to inspect every aspect of the process, and NWBO has to show standardization and sterility controls with each step in the long process to get to a final product, and its easy to see that this approval process is far from ordinary and far from simple. One would expect this approval to take much longer than a standard Big Pharma drug. Lets remember what's involved in the process here and then appreciate why approval will take longer than "average". This is not a simple drug formulation under evaluation.
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