Yes, Linda said artisan first, but I think this MA decision has taken longer, maybe much longer, than Linda expected in the UK. Perhaps long enough that EDEN is ready. If so, I can't imagine she wouldn't just start with automation. Secondly, MRHA knows the number of patients that are asking (demanding?) to receive DCVax-L. Unlike here, DCVax has been in the news over there, including with Parliament asking "What's the hold up?" So, have there been so many requests for DCVax that MHRA and NICE want EDEN up and running when a decision hits? After all, part of the requirement of approval is to have the ability to meet demand.
I'm not saying I believe this is what's happening; I'm saying that if EDEN is really close to approval, I could see MHRA or NICE deciding to wait a few weeks. It might avoid a sloppy opening where NWBO is so overwhelmed with patient requests that they look incompetent.
But there are other possibilities for this long MHRA review: very large application; lots of moving parts to coordinate, such as leukapherisous, pricing, and we know they just recertified the Sawston facility; perhaps the third clean room was holding up the application.
Now that we've learned more about the post-approval requirements on advertising, product labeling, etc., I'm thinking we may be in that phase, in which case, we're days away, maybe?
With all the close contact between NWBO and MHRA, including the years of compassionate care given to patients, I thought we would breeze through the application process, just as others here thought. But thanks to many posters here who have gathered facts surrounding the MAA process that we didn't understand before, we now know why the application had to take at least as long as any other application and had to go through every step carefully, rather than a shorter time frame.
And I thank them for their hard work, including yours, Flipper.
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