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Re: rafunrafun post# 197219

Monday, 06/17/2019 1:39:45 PM

Monday, June 17, 2019 1:39:45 PM

Post# of 425658
I guess you can't tell from available info, is the closed period really have a set end date at end of year? What other closed periods have there been and how long have they been for? Closed periods are common but is one that lasts 6 months common?

Why would it be closed post FDA approval date, is it just caution in case runs late and they just lift it early if on time? If there there really is an end date called out?

Could BO talks add to the need for a closed period in this case (not main driver but part of the reasons for?)

To me it doesn't change anything regardless, definitely does not reduce change of a BO after approval. But the info out there is not detailed enough to know if it has any extra meaning over other closed periods or not.
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