AcuCort is exempted from the application fee by the U.S. Food and Drug Administration
AcuCort AB (publ) (Spotlight Stock Market: ACUC) announces today that the U.S. Food and Drug Administration, FDA, grants the company’s waiver request under the small business waiver provision regarding the application fee for the new drug application of ISICORT®. The positive decision means that AcuCort is exempted from paying an application fee of USD 1.6 million provided that the application is submitted no later than the last day of February 2023.AcuCort identifies, develops, and commercializes smart drugs that meet the patient's medical needs for a quick and effective treatment as well