CorMedix updates DefenCath NDA resubmission pathways; CMO 1 completes corrective actions

CorMedix Inc.

CMO 1 completed all corrective actions from FDA's June 2022 inspection; awaits FDA feedback on compliance status.
Heparin API supplier updated DMF; FDA recently approved a supplement referencing same DMF, potentially removing warning letter barrier.
Company plans to submit Type A meeting request by mid-March to seek FDA guidance on CMO 1 clearance and API 1 DMF use.
Pathway #1 (CMO 1 + API 1) could be Class 1 (60-day review); Pathway #2 (CMO 1 + API 2) data expected mid-April, Class 2 (6-month).
Pathway #3 (CMO 2 + API 2) data delayed to Q3 2023; remains backup strategy.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.