MetVital, Inc.

Met Vital, Inc. will consider providing pre-approval access to our investigational drug, outside of the clinical trial setting, when certain conditions are met. These conditions are as follows:
• The patient to be treated has a serious or immediately life-threatening illness and there is no satisfactory alternative therapy.
• The patient is not eligible for, or cannot access, any ongoing clinical trials.
• The potential benefit of the investigational medicine to the patient, outweighs the potential risk. This should be evaluated by your physician and discussed in detail with the patient.
• There is an adequate supply of the investigational drug, meaning that MetVital, Inc has surplus investigational drug over and above what is required for the ongoing clinical trial.
• Providing the investigational drug will not interfere with the clinical trial that could support a marketing approval.

Requests for our investigational drug must come from a patient’s treating physician. The requesting physician must be willing to work on designing a treatment protocol and obtain the appropriate regulatory and ethics committee approvals from their Institutional Review Board (IRB). MetVital, Inc will not be responsible for the physician gaining IRB approval. The physician must also comply with various regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting.