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Re: drugrunner post# 703287

Tuesday, 07/02/2024 12:49:26 PM

Tuesday, July 02, 2024 12:49:26 PM

Post# of 707607
IMHO, Management moved mountains to overprepare the MAA to such an extent, which likely covered every possible area that could warrant a question. One thing is certain, nothing was rushed, skipped over, or left open for interpretation. No expense was spared to put teams of leading experts to handle sections of the vast application. Imo, it's possible to put an application together, that is so buttoned down, that it could avoid an RFI. Even if the regulators are sophisticated enough to find a question to ask, it's likely to fail to resonate among the regulator team, to such an extent worthy of a clock stoppage. In this case, the expression, "there's no such thing as a stupid question," need not apply.
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