Expanded Access Policy
Lung Therapeutics is focused on improving patients’ lives by identifying and developing meaningful products that address unmet medical needs. We believe that wherever possible,
use of an investigational medicine for a patient as part of a clinical trial is preferable because clinical trials generate data that may lead to the approval of products from regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Regulatory approval enables the medicine to be available to as many patients as quickly as possible. Lung Therapeutics complies with good clinical practice guidelines and takes steps to ensure the quality and integrity of our clinical trials to minimize risks to research participants and future patients. For a list of clinical trials currently recruiting patients, please visit www.clinicaltrials.gov.
Granting access to an investigational unapproved drug through expanded access should not delay, interfere with, or compromise the completion of clinical trials that are intended to
support approval by regulatory authorities. Currently, Lung Therapeutics does not offer an expanded access program for investigational medicines being evaluated in our clinical trials. This policy will remain until such time that there is an investigational medicine under active development wherein the clinical dose and regimen have been defined, and proof of concept have been established.