Development Plan


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


Submit IND Application to FDA

LignaMed plans to submit an IND in 2018


Clinical Studies Completed and NDA Filed with FDA

LignaMed plans to complete clinical studies in 2021 and file NDA


FDA Approval & Product Launch