We believe that the most effective way of achieving this goal is through establishing the benefit/risk profile of our drug product candidates through adequate and well-controlled clinical trials, followed by regulatory approval and commercialization. Patients in need of an investigational product that has not yet been approved are therefore encouraged to participate in one of our clinical trials.
Expanded access refers to the use, outside of a clinical trial, of an investigational drug that is intended to diagnose, prevent or treat a serious condition or immediately life-threatening disease and for which no alternative treatments are available. Expanded access use is usually requested by physicians on behalf of their patients for whom participating in a clinical trial is difficult or impracticable. Iveric Bio understands the need for expanded access and having an established program for these kinds of requests.
At this time, Iveric Bio believes that participation in one of our clinical trials is the most appropriate way to access our investigational drugs. If you wish to seek expanded access to one of our drugs, please have your physician contact us with a formal request at firstname.lastname@example.org. We anticipate acknowledging receipt of requests sent to this email within five business days.
In evaluating expanded access requests, Iveric Bio generally will consider the following factors:
Policy updated April 2020. In line with the 21st Century Cures Act, Iveric Bio may revise this policy at any time.