BioCryst evaluates physician requests for individual patients to receive investigational medicines for serious or life-threatening diseases or conditions outside of a clinical trial on a case-by-case basis. BioCryst cannot guarantee that the investigational medicine will be available for a particular patient.
In evaluating these physician requests, BioCryst considers many factors, including the following:
- Whether the request is likely to interfere with BioCryst’s overall development plan for the medication
- Whether there are other adequate alternative therapies or clinical trials available
- Whether the scientific evidence supports both the safety and the efficacy of the medicine for the requested use at an appropriate dose
- Whether the potential benefit to the patient justifies the potential risks
- Whether an adequate and appropriate supply of the medicine is available
- Whether the requesting physician is sufficiently qualified
A requesting physician should expect to receive a response acknowledging receipt within 7 business days of the receipt of a completed request. For investigational medicines other than berotralstat, requesting physicians should submit an inquiry. If granted, access to the investigational medicine will be provided for a designated period of time and will require additional submissions to continue.
BioCryst may revise this policy at any time.