Anti-drug antibodies were not detected as of Day 29 in any patient. No infusion or injection site reactions were observed. We anticipate interim top-line data from this clinical trial at the end of 2021. Following this data, we have decided to discontinue further development of etokimab. 8226;Retaining rights to strategic products in key commercial markets. GPP is a chronic, life-threatening, rare disease with no currently approved therapies. Fc domains bind to various receptors and cause immune system effector responses. Human B cell screening methodologies. The $1.1 billion in cash milestone payments due under the GSK Agreement remain unchanged. Any patents that we hold may be challenged, circumvented or invalidated by third parties. Orphan Drug Designation must be requested before submitting a BLA. PMA applications are subject to an application fee, which exceeds $250,000 for most PMAs. Different pricing and reimbursement schemes exist in other countries. As a result, increasingly high barriers are being erected to the entry of new products. Other legislative changes have been proposed and adopted since the ACA was enacted. If any of these events were to occur, our business would be harmed, possibly materially. We may not be able to protect our intellectual property rights throughout the world. Such a license may not be available on commercially reasonable terms or at all.