Refer to…
Efficacy and safety of topical sofpironium bromide gel for the treatment of axillary hyperhidrosis: A phase II, randomized, controlled, double-blinded trialBrandon Kirsch et al. J Am Acad Dermatol. 2020 Jun.
Results: At the end of therapy, 70%, 79%, 76%, and 54% of participants in the 5%, 10%, 15%, and vehicle groups exhibited ≥1-point improvement in HDSM-Ax (P < .05).
Assuming the pulled release is accurate. They may have decided to approve a midpoint (chose 12.45%) between 10-15% considering 10% elicited the slightly better results v 15% (79-76%).
note: Approval in Japan is for 5% sofpironium bromide gel.
So no problem at all.
Ann: Trading Halt, page-290
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