Yes, you would not want to have a fundamental question from one of the RA’s going to a core concept, coming after you’ve already unblinded. On the other hand, they might feel confident based upon communications, that no such material comment is coming. But there is like a 30 day deadline for the agency to ask those questions and then the company to answer, iteratively. Not a one time 30 days, but back and forth. If they chose not to ask questions or make comments, then it’s done... but again, as I said before, no guaranty that they agree... they reserve all rights to disagree on seeing the data and analysis. They key is that the SAP’s material analysis was not post hoc.
I get the feeling that despite insistence along the way that people understood what was being said, and that everything just said is consistent with what you said, that some still may not fully understand.
It’s like many bureaucratic details in a process. Sometimes something sounds simple, or linear, but then you have a real life situation and you fill out the forms and do it... and then the detail takes better shape and the rational nature of what might have seemed irrational in the abstract, or vice versa, becomes clear...and voila, it’s not what one understood at the beginning, but it makes sense by its own logic.
I think people don’t realize the various layers... doesn’t mean it will be months and months, but assumptions without actual knowledge become not so great until things actually happen and reality becomes more and more constrained by facts and acts and not assumptions about such matters.
It sounds like they are likely in good shape to me, but I don’t make predictions.
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