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flipper44

01/15/25 12:13 PM

#743832 RE: manibiotech #743827

Actually, think about that for a minute. If we took the normal 60 days clock off to respond, we are 43 days over the average clock on review time. If we took the full 60 days additional clock off (I doubt we took this much if we took any), then that leaves 17 days* (or less) to fall within the average. Looking back at what LP said, she indicated it could be 60 days clock off or somewhere in between 60 and 120 days. A few long in tooth longs have been chanting remember this might take a little bit longer due to two indications being reviewed. I suppose that might be more likely for the clock off then the clock on. Anyway, the other argument I think is bunk. 1.7 million pages is just not exceptional for MHRA reviews.

Net net, we are squarely within the likelyhood of decision window if not in the latter one-third of it. IMO.

(*Note: 17 days from today is Saturday, February 1, 2025)