Sensorion announced that regulatory authorities of 9 out of 10 participating countries have approved Sensorion’s amendment to the Phase 2 AUDIBLE-S study protocol with SENS-401 (Arazasetron) in Sudden Sensorineural Hearing Loss (SSNHL). The last one is still being reviewed and hope to provide an update as soon as possible. As announced with full year results on March 18, 2021, Sensorion had submitted to the regulatory authorities an amendment to the statistical analysis plan for the AUDIBLE-S study that significantly reduced the sample size without compromising the quality or potential outcome of the trial. The study has now a recruitment target of 111 patients and has enrolled 112 patients. Since not all patients have yet completed their 28-day end of treatment visit, Sensorion will continue the recruitment until the end of October 2021. Top line data continues to be expected around year end. The original statistical analysis plan (which was based on a combined phase 2 & phase 3 study) had required a much larger number of patients based on assumptions derived from scientific literature. Sensorion’s revised approach has now been widely accepted by the regulatory authorities and follows the planned interim analysis reviewed by the independent Data Monitoring Committee. The primary outcome measure of the study remains unchanged.