Australian biopharmaceutical company Clinuvel Pharmaceuticals Ltd. (CLVLY) awaits the FDA decision on its lead compound SCENESSE on October 6, 2019.The Company is seeking approval of SCENESSE for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria, a rare genetic disorder. Erythropoietic protoporphyria, or EPP, is characterized by an extreme risk of severe burns (phototoxicity) of the skin, following exposure to bright lights, especially sunlight. SCENESSE was approved in Europe as an orphan medicinal product for this indication in 2014 and was launched in June 2016.The drug is administered subcutaneously as an implant once every 2 months prior to expected and during increased sunlight exposure, e.g. from spring to early autumn. The recommended maximum number of implants is four per year.CLVLY.OB closed Friday’s (Sep.27, 2019) trading at $16.95, down 2.14%.