Botanix Pharmaceuticals Limited advised that it has successfully received confirmation from FDA in writing that the Sofpironium Bromide New Drug Application (NDA) is now formally under review. FDA's communication confirmed that there were no filing review issues identified and that the NDA was sufficiently complete to permit substantive review. FDA also confirmed that they do not believe that an advisory committee meeting is required to discuss the application.

Advisory committee meetings are sometimes convened by FDA to assist in FDA's review of complex applications, or where the opinion of independent experts or the public is viewed as important to the FDA decision making progress. With the formal filing of the Sofpironium Bromide NDA now accepted by FDA and a standard review period confirmed, a mid-cycle review remains on track for First Quarter 2023 which is an important next milestone for Botanix. The mid-cycle review provides FDA management and review teams with an opportunity to discuss the review status, key findings, timelines and any other issues relating to the NDA review which will be communicated to Botanix and will allow to align commercialization plans accordingly.