Business
CORMEDIX INC. REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
Company in process of submitting New Drug Application (NDA) for Neutrolin® for prevention of catheter-related blood stream infections via a rolling review
About this update from Cormedix Inc.
[{"type":"text","content":"Company in process of submitting New Drug Application (NDA) for Neutrolin® for prevention of catheter-related blood stream infections via a rolling review granted by FDA\n Conference Call Scheduled for Today at 4:30 p.m. Eastern Time BERKELEY HEIGHTS, N.J., March 16, 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 financial results for the fourth quarter and full year ended December 31, 2019 and provided an update on recent business developments. Recent Corporate Highlights: The Company has begun the submission process of the New Drug Application (NDA) for Neutrolin® for the prevention of catheter-related blood stream infections (CRBSIs) in hemodialysis patients. The US Food and Drug Administration granted the Company’s request for a rolling review, which is designed to expedite the review process for products being developed to address an unmet medical need. CorMedix has been granted a deferral under the Pediatric Research Equity Act (PREA) that requires sponsors to conduct pediatric studies for NDAs for a new active ingredient, such as taurolidine in Neutrolin, unless a waiver or deferral is obtained from FDA. A deferral acknowledges that a pediatric assessment is required, but permits the applicant to submit the pediatric assessment after the submission of an NDA. CorMedix has made a commitment to conduct the pediatric study after approval of the NDA for use in adult hemodialysis patients, and has submitted a plan for the proposed pediatric study to FDA for review and approval. Pediatric studies for an approved product conducted under PREA may qualify for pediatric exclusivity, which would provide an additional six months of market exclusivity. Neutrolin would then have the potential to receive a total marketing exclusivity period of 10.5 years. The Company believes it is on schedule for potential approval of the NDA during the second half of 2020. However, because the FDA has announced that it is postponing most foreign inspections through April and inspections outside of the US deemed mission-critical will still be considered on a case-by-case basis, we cannot predict if this will delay approval of the NDA. Pre-approval inspections o...