FDA Approves Nova Mantis Orphan Drug Application
Nov 2, 2021 By MarketDepth
Nova Mentis Life Science Corp. (CSE: NOVA) (OTCQB: NMLSF) announced today that its Orphan Drug Application was approved by the U.S. Food & Drug Administration.
The company’s proprietary psilocybin drug is meant to treat patients with fragile X syndrome.
“I am pleased to announce that we are the first biotech company to have psilocybin registered for treatment of FXS in the drug regulatory logs of both the FDA and EMA.”Will Rascan, NOVA’s CEO & President
Drugs that have received the orphan designation from the U.S. FDA and the European Medicines Agency (EMA) receive several benefits such as a 10 year period of market exclusivity; waiver of Prescription Drug User Fee Act; and the ability to qualify to compete for research grants from the Office of Orphan Products Development.
“The attainment of Orphan Drug status in both the U.S. and Europe is a significant milestone towards launch of psilocybin FXS phase 2 clinical studies.”Dr. Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board