Jaguar8 commented on a stock · Nov 25, 2024 21:08

NEWS

Citius Pharmaceuticals Reports Productive FDA Type C Meeting to Discuss Phase 3 Mino-Lok® Program and Pathway to Approval

Citius Pharmaceuticals announced a productive Type C meeting with the FDA following the successful completion of their Phase 3 clinical trial for Mino-Lok®.

The meeting focused on discussing clinical trial data and establishing a pathway for future New Drug Application (NDA) submission. The FDA provided clear and actionable guidance regarding the novel catheter lock solution designed to salvage central venous catheters in patients with bloodstream infections.

The company reports that Mino-Lok® demonstrated compelling clinical outcomes in Phase 3, potentially offering an alternative to catheter removal that could reduce healthcare costs and improve patient outcomes.

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