Expanded Access Policy
On a case-by-case basis, Rebiotix considers requests from US-licensed treating physicians for access to investigational products in Phase II or Phase III of development for patient treatment purposes. Treating physicians may request more information by contacting Rebiotix. Receipt of a request for information will be acknowledged within 10-15 business days if requested. For more information regarding expanded access, please review the resource provided by the FDA here.
The factors that Rebiotix will consider upon receiving a request include:
- The clinical situation and need of the patient for whom the physician seeks access, including whether the patient has a serious or life-threatening illness for which there is no viable alternative therapy;
- Whether the treating physician believes that the potential benefits of the experimental product will outweigh any potential risks to her or her patient;
- The ability of the treating physician to ensure compliance with applicable investigational new drug regulatory requirements, and good clinical practices;
- The extent to which currently available data are sufficient to make an assessment of the benefit and risk of the proposed use of the investigational product and for the patient to provide informed consent for such use;
- Whether regulatory authorities and institutional review boards/ethics committees have approved, or are likely to approve, expanded access to the investigational medicine;
- Whether the medicine is under active development (i.e., the product is already approved, or the development program been discontinued);
- Whether the patient either is ineligible for or is unable to participate in a clinical trial for the investigational product;
- The impact of providing access to an investigational product on the development program for that product, including the ability to complete patient enrollment and other aspects of the clinical trials necessary to secure product approval, and the available supply of the investigational medicine; and
- Such other factors as Rebiotix may deem appropriate to consider, in its full discretion.
This policy is not a guarantee of access to any Rebiotix investigational drug. Rebiotix reserves the right to revise or revoke this policy at any time.