Criteria for Consideration of Compassionate Use Access:
- The request must be submitted to Arog by the treating physician, with contact information so it can be followed up
- There is a good understanding of the indication for the requested use.
- There must be sufficient clinical data to identify an appropriate dose
- The potential benefit must be considered to outweigh the collective potential risks to the patient by offering the investigational product
- Patients with underlying conditions that may pose safety risks would not be eligible to participate
- Patient requirements:
- A serious or life-threatening disease or condition
- Exhausted all available therapies and is no longer responsive or able to tolerate these therapies
- No comparable or satisfactory alternative therapy is available to monitor or treat the disease or condition
- There must be adequate supply of the investigational product without impairing the Arog’s clinical trials
- In the United States, the FDA and IRB at the patient’s hospital must review and approve the use of the investigational product in the patient before Arog can provide it
- Anticipated Timing: Each request will be reviewed fairly and promptly by qualified Arog medical experts with every effort made to provide a response within a maximum of five working days once all required medical information has been received from the treating physician.
5420 LBJ Freeway, Suite 410
Dallas, TX 75240