Expanded Access Policy
Repertoire Immune Medicines conducts research and development to achieve clear, ambitious goals: to advance medical knowledge, determine the safety and efficacy of potential new treatments, and make new treatments available to the greatest number of people in need in the shortest possible time. We believe that the current system for getting new treatments to patients -- conducting well-designed clinical trials, followed by regulatory review and approval -- has a proven track record of accomplishing these goals in a responsible manner.
At the same time, we recognize that some individuals and groups of people suffer from fatal or severely disabling conditions for which there are currently no options. In cases where we are exploring an investigational drug that has a reasonable potential to help such people, we will do our best to provide it. In doing so, ethical principles require that compassion for a few does not do harm to the broader community of patients and their loved ones.
Therefore, our company has adopted principles for addressing requests for early access to medicines:
- The individual must suffer from a life-threatening condition for which no other treatment options exist.
- There must be no other clinical trials underway, or the person must be either categorically ineligible or disqualified from them.
- There must be clear evidence of safety, demonstrated by an early-stage clinical trial, specifically Phase I or Phase II.
- There must be evidence that the investigational drug could be beneficial in the indication for which early access is sought.
- There must be an open Investigational New Drug application (IND) in the U.S., under which human clinical trials are conducted in this country.
- The investigational new drug must be actively in trials for the condition for which access is requested.
- Qualified health professionals must be available to administer and monitor the patient
- Adequate supply of investigational drug available in the country, beyond what is required for clinical trials.
- In the event the company discontinues clinical development of an investigational new drug, compassionate use/expanded access programs will be discontinued as well.
- Once the U.S. Food and Drug Administration has approved a drug for any indication, any expanded access program will come to an end, as the drug is no longer investigational.