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Apellis Policy on Expanded Access

Apellis Policy on Expanded Access

Apellis is committed to deliver innovative therapies to patients with serious diseases.

We believe that the most effective way of achieving this goal is through establishing the risk:benefit profile of our drug products in adequate and well controlled clinical studies followed by regulatory approval and commercialization. Patients in need of an investigational product which has not yet been approved or commercialized are therefore encouraged to participate in one of our clinical trials.

In rare cases, physicians treating patients with serious, life-threatening diseases for which no approved therapy is available and who cannot participate in any clinical study may seek expanded access to investigational products. Expanded access programs are designed to make an investigational therapy available outside a clinical trial with the primary purpose to treat patients with a serious, life threatening condition who have exhausted all available medical options and are unable to enroll in clinical trials.

At this time, participation in one of our clinical trials is the most appropriate way to access our investigational therapies. Physicians seeking additional information regarding expanded access should submit a formal request via email at expandedaccess@apellis.com. We anticipate acknowledging receipt of requests sent to this email within five business days.

In line with the 21st Century Cures Act, Apellis may revise this policy at any time.


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