Approval SetbacksThe company's application for INTERCEPT RBC had previously been under review by the EU Competent Authority and was completed without granting approval.
Data InsufficiencyThe EU Competent Authority, CBG, concluded that the data are insufficient to support the proposed classification of the impurity profile of the final product in CERS' application for INTERCEPT RBC.
Regulatory ChallengesThe review of CERS's CE Mark application for INTERCEPT RBC was completed without receiving approval, prompting the company to assess new strategies for regulatory submission.