Development Plan

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

2022

FDA Approval & Product Launch