Silver Creek Pharmaceuticals

Single-Patient EA Policies/Criteria Expanded Access (sometimes termed as compassionate use, early access or emergency use) refers to the use of an investigational drug outside of a clinical trial, with the primary purpose of treating a serious or immediately life-threatening disease or condition in a patient who has exhausted their treatment options and are not eligible for, or able to participate in a clinical trial. Expanded Access is different from clinical trials in that more comprehensive information about safety and effectiveness are required to be collected in clinical trials. Silver Creek Pharmaceuticals is focused on enrolling and conducting the clinical trials that are needed to bring scp776 to patients as quickly as possible through the regulatory approval process. At this time, Silver Creek Pharmaceuticals is not offering Expanded Access for scp776. We will continue to assess this as our clinical programs progress. We believe that wherever possible, participation in a clinical trial is the best and preferred route to access our investigational medicines. Clinical trials can generate data that may lead to the approval of products and, consequently, to wider availability. For more information on our clinical trials that may be recruiting new patients, please consult www.clinicaltrials.gov . Silver Creek conducts regular review of its policies to ensure conformity with applicable laws and regulations. Consistent with the 21st Century Cures Act, we reserve the right to revise this policy at any time.