Shares of the micro-cap biotech CorMedix Inc. (NYSE: CRMD) were advancing Tuesday following the announcement of positive FDA feedback on the company's lead investigational drug.
The FDA's feedback on the statistical analyses of data and additional information for the primary and secondary endpoints of CorMedix's LOCK-IT-100 clinical study suggests the company does not need to conduct additional clinical trial at this time, and has completed a Phase 3 trial.
The study is evaluating the safety and effectiveness of Neutrolin compared to heparin for the prevention of catheter-related bloodstream infections, or CRBSIs, in hemodialysis patients.
The FDA did not raise any additional questions regarding the analyses provided, CorMedix said. The regulatory agency said it will thoroughly review the clinical data when the clinical study report is submitted.
As to whether the LOCK-IT-100 study is adequate as a single study to support an NDA filing, the FDA said data from the study may be adequate. The agency said it cannot confirm this until it has completed a review of the NDA.
CoreMedix said it will continue discussions with the FDA regarding the chemistry, manufacturing and controls data required for the NDA filing.
Feedback on the CMC data is an important regulatory requirement before it CorMedix can request a pre-NDA meeting, the company said.
CorMedix shares were trading up by 3.54% at $9.65 at the time of publication Tuesday.
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