CorMedix receives second Complete Response Letter from FDA for DefenCath NDA due to manufacturing deficiencies

CorMedix Inc.

FDA issued second CRL stating DefenCath NDA cannot be approved until deficiencies at CMO and heparin supplier are resolved.
No other deficiencies cited; clinical and labeling review completed per the CRL.
CorMedix entered agreement with Alcami as alternative manufacturer; expects to file NDA supplement around end of Q1 2023.
CMS published conditional NTAP reimbursement, effective if FDA approval by July 1, 2023; duplicate NTAP application planned for October 2022.
Management remains confident of pathway to approval in calendar 2023, with both existing CMO remediation and Alcami transfer.

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