Ann: FDA Confirms Approach to Sofdra NDA Resubmission, page-65

FDA doesn’t mention the human factors at all!!
just the packaging, which is seen to be acceptable after BOT has updated it. It said nothing more is required aside from the packaging!!
so it is 5b - draft labeling (now fixed)
with maybe 5i - a minor clarification info such as, can
people read instructions

So if this is purely Class 1, it’ll explain the rush to get the reading part hurried over Xmas!! It’ll be submitted in January and approved by March.
Plus also it’s 6 months from the last rejection which was September so it’s March!!!
The mid 2024 is what I’d say to cover all bets.