Expanded Access

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 info@salspera.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:

• The condition or disease being studied is serious or life-threatening and there are no available alternative treatments;
• The patient is not eligible for an ongoing or planned SALSPERA-sponsored clinical trial;
• There must be sufficient clinical data to identify an appropriate dose for the proposed use;
• The potential benefit to the patient clearly outweighs the collective potential risks;
• There must be adequate supply of the investigational product to meet the needs of the expanded access program without impacting the company’s clinical trials;
• The patient meets any other relevant medical criteria for expanded access to the investigational product, as determined by SALSPERA.

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.