AcuCort AB reported a positive view, concluding that the outcome of the second bioequivalence study for the US is not considered an obstacle for a market application for US registration of the companys drug candidate ISICORT[®]. AcuCort has appointed an expert group with the task to evaluate the results of the second study for the US market, with non-fasting patients, where two of the three criteria for bioequivalence were met. The group has analyzed possible causes for the deviation and has been able to select the most likely cause. This has to do with the fact that two different oral pharmaceutical formulations are compared in the clinic. This results in some pharmacokinetic differences. The expert group has furthermore presented options for courses of action to enable the process of registration and commercialization of ISICORT® on the US market, and AcuCort sees a suitable option to pursue. These conclusions have furthermore been confirmed by two independent regulatory expert bodies in the US and in Germany. The group has also identified that the study design could have included more data points. The management of AcuCort has therefore decided on a pharmacokinetic modeling and simulation study to be performed by experts, in order to ensure the best possible knowledge of the products performance under non-fasting conditions for the continued registration work. As this is a US 505(b)(2) application and not a generics application, certain deviations should be acceptable.