JTORENCE,
I seriously do not know about where exactly the MAA is at right now. MHRA can do just about anything they want to extend the timeline if you look past the official first look superficial guidelines. I agree with exwannabe about that. There are supposed to be a maximum of 2 potential RFIs but the fine print basically says MHRA can do just about anything they want but will likely only extend timelines because of their questions as clock off if there is no major problem being observed and acceptable resolution of questions is timely forthcoming. This is in line with what sentiment_stocks mentioned about back and forth and checking NWBO’s understanding of what is in the application. This would be normal considering the MAA is 1,700,000 pages in length and is probably a good thing to do since subcontractors were hired and NWBO is ultimately responsible for knowing what is in the application and why that is important. NWBO can’t pass the exam if they aren’t the ones taking it; ). Best wishes.
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