FDA DESIGNATIONS

Special designations, such as Fast Track, Priority Review and Orphan Drug status, are awarded by the FDA to companies with particularly promising drugs under development. Cellceutix has received various FDA designations, reinforcing the potential of the company’s pipeline, while also providing better odds of a drug candidate's expedited approval, often with added exclusivity protections. Almost three-in-four drugs (73%) approved by the FDA in the U.S. in 2016 received some form of expedited development and review, with one-in-three (36%) representing first-in-class status.