This strategy will streamline our clinical trials program and accelerate speed to market.
Benefits of orphan designation
protocol assistance and expedited FDA review;
tax credits of 50% of the clinical drug testing cost; research grant funding;
waiver of NDA application fee, (valued at $2.2 million) and 7 years of market exclusivity.
We expect to complete preclinical studies for PCT-3010 in 2019 and hold a pre-IND meeting with the FDA
Polycore plans to submit an IND application in late 2019 or early 2020.
Polycore plans to complete clinical studies in 2023 & file NDA