Expanded Access Policy
Sun BioPharma is dedicated to developing new therapies to extend the lives of patients with pancreatic cancer. We are currently conducting a clinical trial to assess the safety and efficacy of an investigational drug to be used as first line treatment in combination with a standard of care chemotherapeutic regimen for metastatic pancreatic ductal adenocarcinoma.
Making our investigational therapy available through compassionate use or early/expanded access (an “Expanded Access Program”) is a complex matter that we have considered carefully. Providing early access to an investigational therapy can involve unknown risks, as well as an unfounded assumption of therapeutic benefit. Furthermore, an Expanded Access Program may make it harder to complete the studies necessary for the regulatory review and approval process that is ultimately the fastest path to making new therapies available to as many patients as possible.
Based on these considerations, an Expanded Access Program isn’t currently being offered by the company. We will re-evaluate this policy quarterly. In the meantime, we encourage patients to speak with their physicians about the possibility of enrolling in clinical trials in order to gain access to investigational therapies. If you have questions about Sun BioPharma’s Expanded Access Policy, please contact [email protected].