EXPANDED ASSESS POLICY
QX Therapeutics is a biopharmaceutical company focused on developing therapeutic medicines for patients suffering from ARDS and other pulmonary diseases with high un-met medical needs.
The primary objective of our investigational drug products is to make sure they are safe and effective through the clinical trial and regulatory process. The ultimate goal is to make our drug products available to the general public after completed and successful clinical trials and satisfying the global regulatory authorities’ requirements for approval.
In some instances, patients with serious or life-threatening diseases or conditions seek access to investigational drug products outside of a clinical trial setting. The associated provision for requesting access to an investigational drug product is called ‘Expanded Access’ but is also known by other terms such as ‘Compassionate Use’, ‘Early Access’, and ‘Emergency Use’.
The following is QX Therapeutics’ expanded access policy for investigational drug products. This policy is applicable globally and across all therapeutic areas. Further information about QX Therapeutics’ clinical trials is available at Clinicaltrials.gov.
GENERAL CRITERIA
QX Therapeutics stands by the principal that the best path to enable the largest number of patients to have access to a drug product is by making it commercially available through an established health authority approval process. Prior to health authority approval, well-designed clinical trials are needed to obtain data on safety and efficacy. Patients enrolled to the clinical trial will be able to access an investigational drug product under controlled environment and associated safeguards within such clinical trial.
QX Therapeutics understands that in occasional cases patients with serious life-threatening diseases are unable to participate in clinical trials and may have exhausted all available therapies. In these rare cases, QX Therapeutics may consider providing an investigational drug product outside of a clinical trial when supported by adequate clinical data, medical assessment or diagnosis, and other relevant factors, but QX Therapeutics makes no commitment to supply any investigational drug product. Currently, we do not have an expanded access program that allows patients to have access to our investigational drug products prior to FDA approval.
CONTACT FOR EXPANDED ACCESS
To date, QX Therapeutics does not have any investigational drug products available for expanded access. If you have any questions about our investigational drug products or expanded access policy, please contact QX Therapeutics through the following email address: info@qxtherapeutics.com.
PROCESS TO REQUESTING EXPANDED ACCESS
QX Therapeutics is not currently making its investigational drug products available on an expanded access basis anywhere in the world. In the event that QX Therapeutics decides to consider making one or more of its investigational drug products available through an expanded access program, requests for expanded access to QX Therapeutics investigational drug products must come from the patient’s treating physician.
TIMING OF ACKNOWLEDGEMENT
QX Therapeutics anticipates that it will acknowledge receipt of any expanded access questions or requests within five to ten business days of receipt. An acknowledgement of receipt of such questions or requests in no way obligates QX Therapeutics to consider requests for investigational drug products or to supply such investigational drug products.
ADDITIONAL INFORMATION
As stated above, QX Therapeutics is not currently making its investigational drug products available for expanded access use anywhere in the world. In the event that QX Therapeutics decides to make one or more investigational drug products available on an expanded access basis, this policy will be updated with a hyperlink to the expanded access record on clinicaltrials.gov after such record becomes active.
As authorized by the 21st Century Cures Act, QX Therapeutics may revise this expanded access policy at any time. Additionally, the posting of this policy by QX Therapeutics shall not serve as a guarantee of access to any specific investigational drug product by any individual patient.