Yes I do remember those things. But, all accepted applications have had rapporteurs assigned and 90%+ applications have a clock stop 1 and 60% have a clock stop 2. Am pumped about this MAA and just trying to understand what we will learn when, and whether what we learn can be construed as being important/material.
EMA rules require the company to work with rapporteurs no sooner than 18 and no later than 6 months prior to submitting a MAA. That is a lot of time for the submittal to be massaged into just what the EMA wants to see.
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