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COMPLETES SUCCESSFUL CMC INTERACTION WITH THE FDA

Key Takeaway: COMPLETES SUCCESSFUL CMC INTERACTION WITH THE FDA NJ - October 16, 2019 - 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, tod

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COMPLETES SUCCESSFUL CMC INTERACTION WITH THE FDA
NJ - October 16, 2019 - 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
it has completed its interaction with the FDA related to the chemistry, manufacturing and controls (CMC) package that will be needed
to support Neutrolin's new drug application (NDA). The FDA was supportive of Neutrolin's proposed manufacturing program,
including the active pharmaceutical ingredients (API), the container closure and testing, and indicated that it will
conduct a thorough review of all of the CMC information as well as assess the commercial readiness of the various manufacturing
facilities at the time of NDA filing. No further CMC meetings with FDA are planned prior to NDA submission.
has now been scheduled and CorMedix is looking forward to discussing with the FDA the filing of the NDA for Neutrolin , including
the FDA programs intended to facilitate and expedite review of the application, such as Priority Review designation, rolling submission,
President and CEO of CorMedix commented, "We are very pleased with FDA's feedback on the CMC package and with the scheduling
of a pre-NDA meeting. We are continuing to move forward with preparations for the filing of the NDA for Neutrolin in accordance
with our plans, which are focused on obtaining an approval for Neutrolin in adult hemodialysis. We anticipate that Neutrolin can
be approved in the second half of 2020 and we intend to launch Neutrolin commercially in the US promptly after its approval either
by ourselves or with a partner."
is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment
of infectious and inflammatory diseases. The Company is focused on developing its lead product Neutrolin , a novel, non-antibiotic
antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous
catheters, currently in Phase 3 development for patients undergoing chronic hemodialysis. Such infections cost the U.S. healthcare
system approximately $6 billion annually and contribute significantly to increased morbidity and mortality. Neutrolin has FDA Fast
Track status and is designated as a Qualified Infectious Disease Product, which provides the potential for priority review
of a marketing application by FDA and allows for 5 additional years of QIDP market exclusivity in the event of U.S. approval. Neutrolin
is already marketed as a CE Marked product in Europe and other territories. In parallel, CorMedix is leveraging its taurolidine
technology to develop a pipeline of antimicrobial medical devices, with active programs in surgical sutures and meshes, and topical
hydrogels. The company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric
cancers. For more information, visit: www.cormedix.com.
Forward-Looking Statements
contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject
to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations,
beliefs, goals, plans or CorMedix's prospects, future financial position, financing plans, future revenues and projected
costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or
estimates due to a variety of important factors, including: the information, costs and time needed to submit to the FDA a new drug
application for Neutrolin in adult hemodialysis, including; risks related to obtaining FDA approval of the new drug application
for Neutrolin; relying on preclinical results that may not be indicative of success in clinical trials and might not be replicated
in any subsequent studies or trials; the risks and uncertainties associated with research for additional uses for taurolidine;
the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources and the impact on current,
planned or future research, including the continued development of Neutrolin and research for additional uses for taurolidine;
obtaining additional financing to support CorMedix's research and development and clinical activities and operations; and
the ability to retain and hire necessary personnel to staff our operations appropriately. These and other risks are described in
greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website
at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking
statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend
to update these forward-looking statements, except as required by law.
Last updated: Oct 16, 2019