Krisgo, I really believe that all the time they're taking is a strong indication they'll approve. The regulators I've observed will normally say no in a timely way, perhaps with suggestions of what's needed to gain approval on next approach.
The time in evaluation, the ongoing inspections, etc. all seem to be saying that the UK and the company are working closely together to do it right.
I don't know what right is, could it be that they're gathering more information that supports a tumor agnostic label? Or could they be working to approve the EDEN at the same time they approve the vaccine? Or could they be working with NWBO on the conformational trials they want to prove how much more effective the vaccine can be with certain other combinations of therapeutics? I really have no idea what they may have been working on, but I believe in the end it will be very positive.
Yesterday a poster pointed out how actually the approval could involve multiple regulators and the delay requested by the company so all of the regulators requirements are met. I can't say this is, or isn't happening, but if it were, it would almost certainly require approval of the EDEN Unit.
While a multi-regulator approval would be a spectacular outcome, I have no idea what's true, or false, but I believe anything is possible and that the company may be bound to say nothing about it until something official occurs.
Gary
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