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Wednesday, November 18, 2020

CorMedix up as FDA says no advisory meet required for Defencath application

  • CorMedix shares climb 14% in premarket, after the company said the FDA has decided to cancel the Antimicrobial Drug Advisory Committee meeting tentatively scheduled for January 14, 2021, to discuss the marketing application for Defencath, to be used as a catheter lock solution in hemodialysis patients for the prevention of catheter-related bloodstream infections.
  • The company was notified that based on the agency’s ongoing dialogue with CorMedix, discussion at an advisory committee is not needed, and it will continue to work on the application with the company during the remainder of the review cycle.
  • Agency's action remains February 28, 2021.
  • https://seekingalpha.com/news/3637495-cormedix-surges-fda-says-no-advisory-meeting-required-for-defencath-application

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