$CRMD Key regulatory decisions scheduled for August:
Can Second Time Be Charm For CorMedix?
Company: CorMedix, Inc. (NASDAQ: CRMD)
Type of Application: NDA
Candidate: defencath
Indication: catheter-related blood stream infections
Date: August 29 (estimated)
Defencath is to be used as a catheter lock solution in hemodialysis patients for the prevention of catheter-related bloodstream infections. The original application was issued a CRL in March 2021.
CorMedix filed a resubmission in late February, and it was accepted as a complete Class 2 response, with a six-month review cycle, in late March. The new PDUFA date could potentially be on August 29.
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