Malcom Gladwell’s latest hypothesis is that the ability to change one’s mind is an attribute. I’ve come to the realization that from time of application, MAA can actually be a faster process than the Commercial manufacturing license process, because of the new and speedier pathways available in the UK. Being that is a possibility, my comment that application for MAA should be submitted no more than 30 days after commercial license application could display my idiocy, not NWBO’s. While I may be only a few weeks off, it would seem that if one files an MAA too soon after commercial license for manufacturing application, the cart might arrive before the horse which is not how the system works. Anyway, to the best of my thinking, for what that’s worth, based upon many factors, I’d say we are currently within a one month window for an MAA acceptance announcement spanning from now to about September 15.
DI’s email response to me yesterday in response to my query whether they would announce any MAA acceptance promptly was responded to quickly with the comment that it is a milestone.
Well, so is submitting it, so I guess they will announce any acceptance promptly, but they might also, I suppose, announce submission, although the two may be so close in time, if validation is rapid, that any announcements might be simultaneous.
Best wishes to patients.
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