Ann: Botanix Placement Secures $13.5M to Fund Sofdra Launch Prep, page-45

As I understand it, the 30-day meeting is the meeting BOT are entitled to, following receipt of the Complete Response Letter. The FDA have 30 days in which to meet BOT if BOT request such. It is expected BOT will discuss the Complete Response Letter with the FDA at that meeting and hopefully, the FDA might provide some detail or assurance that the proposed changes BOT will have made to the instructions and labelling, seem okay. That being the case, BOT would then proceed with the HF study aligned with the amended instructions/labelling. So yes, once that HF study is complete, BOT can then resubmit for approval (Q1 2024CY). Initially the FDA expert lawyer said it was an 'up-to' 6-month approval process and that the FDA would usually take the full 6 months. But I am unaware if there has been any indication from BOT since then that the approval will be quicker, e.g. 2 months or so.