Dimerix Limited confirmed that the Company is in active discussions with the FDA on the Phase 3 study design in focal segmental glomerulosclerosis (FSGS), including appropriate endpoints for Accelerated Approval. According to the US Food and Drug Administration (FDA), Accelerated Approval is appropriate for drugs for serious conditions that fill an unmet medical need and can be based on a surrogate clinical endpoint, such as proteinuria levels in kidney disease. The data to support accelerated approval must demonstrate sufficient clinical benefit to justify any risks associated with the drug.