Compassionate Use/Expanded Access Requests
What is Compassionate Use/Expanded Access?
When patients suffering from a serious or life-threatening condition, such as Alzheimer’s disease, have not found an effective treatment, their doctors can request access to investigational drugs that haven’t been approved by the FDA: such access is often called “compassionate use” or “expanded access.” Usually, a physician will contact the company that makes the investigational drug with a treatment plan and the company can agree to provide the investigational drug. But not all companies provide investigational drugs for compassionate use or expanded access.
T3D’s Policy Regarding Compassionate Use
Although we understand the suffering that Alzheimer’s causes patients, their families, and their caretakers, T3D is currently unable to provide its investigational drugs for compassionate use/expanded access. T3D is performing clinical studies and long-term safety studies for its lead investigational drug, T3D-959, and T3D’s other investigational drug candidates are not yet ready for human use. While T3D completes its studies, the available supply of T3D-959 is needed to ensure that the studies can be completed according to their scientific design. As such, it is T3D’s policy not to provide T3D-959 or other investigational drug candidates for compassionate use/expanded access.
Although T3D is currently unable to provide T3D-959 for compassionate use/expanded access, you might be eligible to enroll in a future clinical study related to T3D-959. Information about potential future studies will be posted at clinicaltrials.gov
Please keep in mind, however, that investigational drugs used in clinical studies have not been approved by the FDA. Thus, the clinical study could have risks/discomforts and might not provide any benefit. Before participating in any clinical study, you should consider possible alternatives and ask your doctor any questions you might have about the study.
T3D will periodically reevaluate its policy regarding compassionate use/expanded access and, if the policy is changed, T3D will update this website with the updated policy and will provide additional information about any investigational drugs that may be available for compassionate use/expanded access.
Please contact [John Didsbury at firstname.lastname@example.org or 919-237-4897] if you have any questions about this policy or compassionate use/expanded access requests, and you will usually receive a response within five business days.