It is the date with which the FDA target to comply with (i.e. 6 months from resubmission), but to be fair, I don't think they are legally liable if they were to go over it. That said, these target dates are not taken lightly and are almost legislation (the FDA draw the target dates in accordance with legislative aims). The FDA quote review timeframes for the type of submission/resubmission. The last anticipated FDA approval for BOT went down precisely to the wire.
Ann: Final Sofdra Labelling Discussions with FDA, page-235
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