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Re: manibiotech post# 551512

Wednesday, 12/21/2022 9:32:50 AM

Wednesday, December 21, 2022 9:32:50 AM

Post# of 820951
They can say it is submitted pending acceptance. Or that they have done their initial submission. But what would be the point if they do not yet know if that is a complete application yet? They might be very sure, but it is up to them. I would not want to hold them to something that they may decide that they need to be certain about just because the PR guy says he "did not see" a reason why not... that is not an answer without reasonable conditionality, in other words, he's not the regulatory person and what he did not see in that moment, might be made clear to him at some point, and that would be that filing the application is complete when it is ACCEPTED, not just when you do the initial filing. The FDA could accept it quickly or even it could be on a rolling basis, which would make an application event even less clear.
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