Tuesday, January 02, 2024 10:55:17 PM
Flipper, I think the question may properly be, did they do a rolling review on the MAA, make suggested changes, so at most what they may be seeing are some changes they hadn't fully reviewed, or is much that's in the MAA new to them. If in fact the rolling review has been done all along, than acceptance could come very rapidly, if not, perhaps it will take awhile, and they may even be asked to make some changes before acceptance.
I'm one who believes it's been under a rolling review, but I can't be certain of that. If we do gain acceptance in the next week, or so, I think it's because they've largely already reviewed it. If that's the case, I also think it could lead to approval in substantially less time than the 5 months they allow themselves. Today was Boxer's Day in the UK, so tomorrow would be the first day something is possible, but I'm not expecting it that fast, but anything is possible.
Gary
I'm one who believes it's been under a rolling review, but I can't be certain of that. If we do gain acceptance in the next week, or so, I think it's because they've largely already reviewed it. If that's the case, I also think it could lead to approval in substantially less time than the 5 months they allow themselves. Today was Boxer's Day in the UK, so tomorrow would be the first day something is possible, but I'm not expecting it that fast, but anything is possible.
Gary
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