We continually evaluate the benefit-risk profile of our investigational drug(s) based upon evolving clinical data. The fact that an investigational drug is made available for the treatment of a particular patient does not mean it will be made available in response to other requests on behalf of other patients whose circumstances and medical histories may be different. Requests will be considered on a case-by-case basis.
LBS is committed to evaluating all requests in a fair and equitable manner. All requests must be submitted by the patient’s treating physician; LBS may require more detailed information in order to fully evaluate a request. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals and comply with regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting. Each request will be given careful consideration by LBS, whose decisions are final.
Physicians seeking pre-approval access for patients with no alternative treatment options should submit their requests to firstname.lastname@example.org. We regularly monitor this mailbox, with the intent, as reasonably possible, to acknowledge each submitted request within 5 business days of receipt, and to review and respond to each proper request within 10 business days of receipt.