sEphB4-HSA
We ask that the physician in charge of the patient ask for Pre-approval access to investigational drug. Each request will be reviewed by a physician to assure that the eligible patients can receive pre-approval investigational drug.
Decisions for Pre-Approval Access to the investigational medicine will be based on the safe use in the patient, given the investigational nature of these medicines that have not completed clinical trials for the specific disease and state. Next is the likelihood of benefit for the patient based on the clinical results of the investigational medicine. Discussion with the physician managing the patient will help determine if the investigational agent is the best option for the patient. Decisions for drug access will be made in a fair and equitable process. There is no guarantee that each request will be fulfilled.
We must also ensure that by providing the drug outside the clinical trial the completion of the trial, and thus drug development plan, regulatory review and approval is not adversely affected.
Request for Pre-Approval Access must be made by your physician who will request the drug from VasGene Therapeutics, Inc. VasGene will respond to the request within 5 business days.
Below are the Eligibility Criteria for the request:
· The illness must be serious or life threatening.
· There are no other viable options (including approved products or active clinical trials).
· There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks based on
what is known at present.
· There is a plan in place to make the medicine, once approved, available commercially.
· Whether or not sufficient quantities of the investigational medicine are available.
· Additional regarding the therapy, its development program, the patient, or other circumstances may impact eligibility.