Additional Relevant Details OTIVIDEX: FDA’s review of the OTIVIDEX statistical analysis plan confirms use of the Negative Binomial model for analysis of the primary endpoint in the ongoing Phase 3 clinical trial in Ménière’s disease. In July 2020, Otonomy submitted a revised statistical analysis plan for the ongoing trial to the U.S. Food and Drug Administration (FDA) that proposed use of the Negative Binomial model for primary analysis of the daily vertigo count data reported by patients. Otonomy believes that this statistical test provides the best fit of the OTIVIDEX clinical data based on the Phase 2b trial, the AVERTS-2 Phase 3 trial, and the integrated dataset from both trials. As previously reported, the ongoing Phase 3 clinical trial has completed enrollment and results are expected in the first quarter of 2021.