2017
Apply for Orphan Designation (Idiopathic Pulmonary Fibrosis) with the FDA
This strategy will streamline our clinical 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 (value at $2.2 million) and 7 years of market exclusivity
Preclinical Studies Completion
We expect to complete preclinical studies for LGM2605 in 2017-2018
2018
Submit IND Application to FDA
LignaMed plans to submit an IND in 2018
2021
Clinical Studies Completed and NDA Filed with FDA
LignaMed plans to complete clinical studies in 2021 and file NDA