Expanded Access Policy
ACCESS TO INVESTIGATIONAL MEDICINES PRIOR TO REGULATORY APPROVAL THROUGH CLINICAL TRIALS
Retrotope Inc. (“Retrotope”) is a clinical-stage pharmaceutical company that is focused on developing novel therapeutics for treating various degenerative diseases. In general, new therapeutics must be reviewed and approved by a regulatory authority, such as the U.S. Food and Drug Administration (FDA), before they become commercially available. Investigational drug products that have not yet been approved by FDA may, or may not, be effective as a treatment, and the use of such investigational products may cause unexpected serious side effects.
Retrotope understands that some patients may seek access to investigational products before they are approved by regulatory authorities. Wherever possible, we encourage patients to participate in clinical trials, which offer the safest and best opportunity for patients to access an investigational product before regulatory approval. Clinical trials are research studies designed to evaluate whether a new therapeutic is safe and effective for patients. Data generated by clinical trials are then evaluated by regulatory authorities to determine whether the investigational product can be approved for commercialization.
For information on Retrotope clinical trials, please visit www.clinicaltrials.gov.
Retrotope’s Expanded Access Policy
However, in rare cases, some patients may not meet the requirements for participating in clinical trials and have exhausted all available treatment options. These patients may be able to receive an investigational drug under an expanded access protocol. Expanded access, also called compassionate use, refers to a pathway in which patients with serious or immediately life-threatening diseases may gain access to an investigational therapy outside the context of participation in clinical trials.
Retrotope is committed to formal testing of its drug candidates through the traditional clinical trial process. At this time, Retrotope does not accept any new requests for expanded access to any of our investigational drug candidates outside of formal clinical trials.
For additional information
Licensed healthcare providers who have questions regarding Retrotope’s investigational drug candidates or ongoing clinical trials may contact Retrotope’s Manager of Clinical Operations and Patient Relations, Sarah Endemann at firstname.lastname@example.org.
Physicians located in the U.S. may find additional information regarding expanded access to investigational products by visiting the FDA website: Expanded Access: Information for Physicians.