We are currently focused on developing SALTIKVA for the treatment of metastatic pancreatic cancer. These trials require rigorous evaluation of the safety and efficacy of SALTIKVA. If these trials provide substantial evidence that SALTIKVA is safe and effective, we will seek marketing approvals from regulatory health authorities to make SALTIKVA available to patients.
We recognize that there may be situations where a patient with a serious or life-threatening condition will not qualify for a SALSPERA-sponsored clinical trial and may seek access to an investigational medicine outside of a clinical trial setting. This process is known as expanded access, treatment use or compassionate use. We are not planning to make SALTIKVA available on an expanded access basis at this time. Nonetheless, we will evaluate and respond to expanded access requests on a case-by-case basis, consistent with the following policy.
1. Contact Information. If you have any questions about SALSPERA’s expanded access policy or wish to make an expanded access request, please contact email@example.com.
2. Request Procedures. An expanded access request must provide sufficient supporting detail to enable us to evaluate your request. Please also include your contact information so that we may follow up with you directly.
3. General Criteria. Although SALSPERA retains sole discretion in deciding whether to grant an expanded access request, the following criteria will guide evaluation of requests:
4. Anticipated Timing. We anticipate acknowledging receipt of any expanded access questions or requests within 10 business days of receipt.
As authorized by the 21st Century Cures Act, SALSPERA may revise this expanded access policy at any time. Additionally, the posting of this policy by SALSPERA shall not serve as a guarantee of access to any specific investigational drug by any individual patient.