In cases where a clinical trial is not an option, Fennec may elect to provide physician-requested expanded access to its investigational medicines in the U.S. and other countries where Fennec intends to submit an application for marketing authorization of the requested product. Treating physicians and patients should note that investigational medicines do not have established safety and efficacy, so all potential risks and benefits should be carefully evaluated before seeking expanded access to unapproved medicines. Fennec will consider requests for access to its investigational medicines, as permitted by applicable law, in very specific circumstances, when all of the following criteria are met:
- The patient has a serious or immediately life threatening disease for which no alternative therapies are currently available.
- The expanded access program is authorized for the requested indication.
- There is adequate clinical evidence of a positive benefit to risk profile for the investigational medicine in the disease indication, suggesting that a clinically meaningful benefit may be expected and that the benefits outweigh any potential risks.
- Providing investigational medicine through expanded access will not compromise clinical trials or the regulatory pathway.
Physicians seeking expanded access to a Fennec investigational product on behalf of their patient should submit an inquiry to firstname.lastname@example.org. Fennec will promptly acknowledge receipt of requests from treating physicians, generally within 24-48 hours of receiving the request for information. Physicians will then be directed to submit required documentation to Fennec.
Medical professionals at Fennec who are familiar with the data collected on the investigational drug will evaluate the request based on the scientific evidence available at the time of the request. Fennec will strive to respond to the treating physician immediately after the receipt of required medical documentation. If Fennec supports the request for investigational medicine, final approval from regulatory bodies then follows.
Physicians who receive a Fennec investigational medicine for their patients through the expanded access program must comply with all applicable laws and regulations, contractual conditions, safety reporting required by regulatory agencies, and protection of intellectual property.
This policy is subject to change. Fennec will revisit the policy periodically and amend it as appropriate.