Ann: Botanix Partners with Telehealth Provider UpScriptHealth, page-47

It is worth noting, that unlike the original approval date that was set by the FDA to occur 12 months after submission, this resubmission review gives the FDA "up to" 6 months to review & finalize. It is not beyond the realms of possibility that the FDA approve the resubmission within 2-4 months, particularly for such trivial items - labeling & instructions, accompanied by a HF study - and thus bringing forward the approval date to March-May (if BOT submit in January). I think the company have laid out the worst case scenario for approval - better to go with that and please the market with an earlier timeline, than go short and have to explain delays. But it is the FDA, so they may take their full 6 months too!