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longfellow95

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longfellow95

Re: anders2211 post# 287648

Saturday, 06/06/2020 9:35:20 AM

Saturday, June 06, 2020 9:35:20 AM

Post# of 701168
Beartrap is right. Any significant amendment or update to the SAP, particularly the last one for unblind would be sent to the regulator for them to comment if they wish to do so.
You don't want your BLA laughed out of court in five minutes, so you run the last revision of the SAP past the regulator.
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