Approval TimelineRequests for further technical and biopharmaceutics information are likely to extend the regulatory review timeline for NEXLIZET, delaying potential commercialization and near-term revenue contribution.
Manufacturing Processes RiskOutstanding questions about manufacturing processes for the licensed asset could complicate approvals across multiple jurisdictions that rely on the same manufacturing data.
Regulatory ComplianceRegulatory authority issued a Notice of Non-Compliance for NEXLIZET, requesting additional chemistry, manufacturing and biopharmaceutics data and creating approval uncertainty.