CorMedix Inc (CRMD)

[desarcmo]

Moving along slowly. 60 days before NDA submission review complete. Then if given priority review another 6 months before approval. Nothing happening fast in the FDA review process.

BERKELEY HEIGHTS, N.J., July 08, 2020 (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that all of the modules for the Defencath(TM) New Drug Application (NDA) have been submitted to the Food and Drug Administration (FDA). Defencath is being developed as a catheter lock solution with an initial indication for use of preventing catheter-related bloodstream infections (CRBSIs) in patients with end-stage renal disease who are receiving hemodialysis via a central venous catheter. The NDA was granted rolling submission and review by FDA as announced previously, and there has been ongoing dialogue with FDA as it reviews the submitted modules. The NDA contained data from the Company's Phase 3 trial, LOCK-IT-100, in patients undergoing hemodialysis for end-stage renal disease, which showed a 71% reduction in CRBSIs relative to the heparin control arm (p=0.0006) with a good safety profile.

The Company requested priority review of the NDA, based on the Fast Track and Qualified Infectious Disease Product Designations granted by FDA to Defencath. The FDA has 60 days to review the submission for completeness to make a filing decision and grant a priority or standard review. FDA will have a goal of a 6 month review period for priority review, compared to 10 months for a standard review.

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