https://hotcopper.com.au/threads/ann-fda-confirms-phase-3-study-d...

https://hotcopper.com.au/threads/ann-fda-confirms-phase-3-study-design-in-fsgs-kidney-disease.6168770/

Accelerated approval on interim data The FDA was broadly supportive of the proposed Phase 3 study design. The meeting minutes from the FDA provided clarity on the single Phase 3 study in FSGS patients to support accelerated approval endpoints, such as protein in the urine (proteinuria) and its relationship to kidney function (eGFRslope). The FDA confirmed that improvement in proteinuria was an acceptable surrogate endpoint for accelerated approval, with sufficient demonstration of the relationship to kidney function. The FDA also provided guidance on the statistical analysis of the data used to support the accelerated approval.
Dimerix has designed several interim analyses into the proposed Phase 3 design to capture evidence of proteinuria and kidney function during the study, aimed at generating sufficient evidence for generating regulatory agencies to assess DMX-200 for accelerated marketing approval. The FDA has confirmed that this general approach is also acceptable, providing further advice on the first interim analysis review.