FDA confirms AcuCort’s study design for the United States

AcuCort AB (Spotlight Stock Market: ACUC) today announces that the company has received a positive response from the US Food and Drug Administration (FDA) to the questions asked concerning the design of the bioequivalence studies that will be the basis for a registration application for the company’s innovative allergy drug Dexa ODF in the US.Before starting clinical studies that will be the basis for a registration application in the US, it is customary to have a pre-meeting, a so-called pre-IND meeting, with the FDA to ensure that a planned study meets the authority’s requirements on a