CorMedix · Nasdaq: CRMD · DefenCath (taurolidine and heparin)

DefenCath after the FDA's letters: the record, reconstructed.

2 FDA letters on NDA 214520, read alongside CorMedix's SEC filings. What changed after each FDA decision, in 9 questions answered from 20 source documents.

Quotes an FDA letterQuotes a company filingA line joins two questions whose answers quote the same passage. Hover a question to trace it.

What did the FDA's first letter on DefenCath require?FEB 2021What did the FDA's firstletter on DefenCath require?1 document · 4 connectedHow did CorMedix describe the FDA's first letter?MAR 2021 – FEB 2022How did CorMedix describe theFDA's first letter?4 documents · 2 connectedWhat did CorMedix say it fixed before resubmitting DefenCath in 2022?APR 2021 – MAR 2022What did CorMedix say itfixed before resubmittingDefenCath in 2022?7 documents · 2 connectedWhat changed between the FDA's first and second letters on DefenCath?FEB 2021 → AUG 2022What changed between theFDA's first and secondletters on DefenCath?2 documents · 4 connectedHow did CorMedix describe the FDA's second letter?AUG 2022How did CorMedix describe theFDA's second letter?4 documents · 6 connectedHow did a heparin supplier's warning letter for another product hold up DefenCath?FEB 2022 – MAR 2026How did a heparin supplier'swarning letter for anotherproduct hold up DefenCath?8 documents · 4 connectedWhy did the FDA call the name Defencath unacceptable in 2022?2021 – 2026Why did the FDA call the nameDefencath unacceptable in2022?3 documents · 3 connectedWhich manufacturer was DefenCath approved with, and what happened to the alternatives?AUG 2022 – MAR 2026Which manufacturer wasDefenCath approved with, andwhat happened to thealternatives?8 documents · 3 connectedWhat did the shareholder lawsuits over DefenCath's FDA letters lead to?JUL 2021 – AUG 2026What did the shareholderlawsuits over DefenCath's FDAletters lead to?4 documents · 2 connectedWhat did the FDA's first letter on DefenCath require?FEB 2021What did the FDA's first letteron DefenCath require?How did CorMedix describe the FDA's first letter?MAR 2021 – FEB 2022How did CorMedix describe theFDA's first letter?What did CorMedix say it fixed before resubmitting DefenCath in 2022?APR 2021 – MAR 2022What did CorMedix say it fixedbefore resubmitting DefenCath in2022?What changed between the FDA's first and second letters on DefenCath?FEB 2021 → AUG 2022What changed between the FDA'sfirst and second letters onDefenCath?How did CorMedix describe the FDA's second letter?AUG 2022How did CorMedix describe theFDA's second letter?Why did the FDA call the name Defencath unacceptable in 2022?2021 – 2026Why did the FDA call the nameDefencath unacceptable in 2022?How did a heparin supplier's warning letter for another product hold up DefenCath?FEB 2022 – MAR 2026How did a heparin supplier'swarning letter for anotherproduct hold up DefenCath?Which manufacturer was DefenCath approved with, and what happened to the alternatives?AUG 2022 – MAR 2026Which manufacturer was DefenCathapproved with, and what happenedto the alternatives?What did the shareholder lawsuits over DefenCath's FDA letters lead to?JUL 2021 – AUG 2026What did the shareholder lawsuitsover DefenCath's FDA letters leadto?

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Prepared from public FDA letters and SEC filings: every quoted passage is matched to the original document, and every “not in” statement comes from a search of the whole document, before it is published. Questions, summaries and connecting sentences are EphemerisX’s wording. Not investment advice. How this research works → · Ask the FDA and SEC Ephemeris →