Ann: FDA Confirms Approach to Sofdra NDA Resubmission, page-75

That is a human factors study; the simple can "people understand" instructions test done by BOT. The human factors study is not a clinical trial (which takes years) but it still takes about 2-3 months. This will be finished, together with labelling etc in Jan, then submission, then 6 months from then that submission date.

Here is the announcement, after their FDA meeting, where BOT says what needs to be done...

"FDA confirmed that the planned content of materials proposed by Botanix would be acceptable for
the resubmission of the Sofdra NDA package which is scheduled to be provided to FDA in early 1Q
CY2024.
These materials are limited to the revised patient instructions for use (“IFU”); the new
human factors validation study protocol and report; an updated use-related risk analysis and
updated draft prescribing information, carton, and container labels; and the proposed proprietary
name (Sofdra) submission.

Botanix will also bring forward the annual safety update to FDA including
the pharmacovigilance report from Japan and any new safety findings reported in the scientific
literature (which would otherwise usually be filed in March each year). All of these materials are
either prepared or will be finalized in preparation for the planned resubmission in early 1Q CY2024."

Howie McKinnon quote...

"The team will be working over the holiday break to ensure we complete the human factors study and
assemble the materials for resubmission to allow a rapid turnaround and filing with FDA for Sofdra
approval.”