Expanded access refers to the use of an investigational therapy outside a clinical trial contact when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient. This is different from a clinical trial, where more comprehensive safety and efficacy data are collected. Our goal is to provide access to our investigational therapies at the appropriate time and in the correct manner for patients.
At this time, participation in one of our clinical trials is the most appropriate way to access our investigational therapies, and we do not currently offer access (including “expanded access”) outside of those trials. Consistent with our mission, we encourage awareness of and participation in our clinical trials. Clinical trials are controlled research studies in humans designed to determine if an investigational drug or device is safe and effective.
You can access information on INOVIO’s clinical trials by visiting https://clinicaltrials.gov/.
If you have questions about expanded access, please speak with your physician or have your physician contact email@example.com. We anticipate responding to inquiries sent to this email within five business days.
In line with the 21st Century Cures Act, INOVIO may revise this policy at any time.
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