Thinly traded micro cap CorMedix (NYSEMKT:CRMD) is up 5% premarket on light volume in response to its announcement that
it has completed its interactions with the FDA regarding the Chemistry,
Manufacturing and Controls (CMC) data package that will support its New
Drug Application (NDA) for Neutrolin as a catheter lock solution for
the prevention of catheter-related bloodstream infections in
hemodialysis patients.
The company says the agency supports its proposed
manufacturing program and plans to conduct a thorough review of the data
package and commercial readiness of its manufacturing facilities at the
time of filing.
A pre-NDA meeting has been scheduled.
https://seekingalpha.com/news/3506102-cormedix-5-percent-premarket-advancement-neutrolin-nda
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