An expanded access program (also known as EAP) and sometimes called “compassionate use” is a potential pathway for a patient with an immediately life-threatening condition or serious disease to gain access to an investigational drug for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. These investigational drugs have not yet been approved or cleared by regulatory bodies like the FDA, and these products have not yet been found to be safe and effective for their specific use.
We understand that some healthcare professionals may wish to access our investigational drugs for certain patients. At this stage of development and clinical trials for our cell therapies, BlueRock is unable to support expanded access. Therefore, BlueRock Therapeutics does not currently offer an expanded access or a compassionate use program at this time.
This policy may be revised from time to time. Please refer back to this webpage for the most current policy. The most appropriate way for patients to access our investigational drugs is by participating in our clinical trials. If you would like to know more about our ongoing clinical trials, visit www.clinicaltrials.gov.