The U.S. Food and Drug Administration (FDA) has finally accepted the first NDA belonging to CorMedix Inc (NYSEAMERICAN:CRMD). This company knows the frustration that the catheter-related bloodstream infections (CRBSI) causes the hemodialysis patients, and has been seeking to offer a leading solution.
Towards the end of June, CorMedix completed the rolling submission and review granted by the FDA. Later on, it learned that the body had given its product a priority review. Asides from that, it also settled for February 28, 2021, as the Prescription Drug User Fee Act (PDUFA) date, in which case it looks forward to approving the company’s NDA.
If all moves according to plan, the agency may soon conduct an advisory committee meeting. The subject of discussion will be the application in question. It comes out clearly to point out that so far, it hasn’t yet come across any potential review issues.
Thoughts of top officials
The company’s CEO, Khoso Baluch, describes acceptance as a massive achievement for the teams working day and night to ensure the company achieves success. He congratulates the team, saying that its contribution has played a huge role in getting them to where they are currently.
CorMedix promises patients access to Defencath, and that implies that they will be able to deal with the serious complications. Asides from that, they will be spared the costs linked to the treatment of CRBSI. The population suffering from the condition is quite huge as sources reveal, and thus the company will help enhance many lives.
The Executive Vice President and General Counsel of CorMedix admit that he has been one of those that have been actively involved in the Defencath program and regulatory quest. They have been doing that for years now, and he is glad that their efforts are now paying off. He is quite pleased about the regulatory body’s move, outlining that it marks a turnaround time to the struggling population in the US. According to him, their product is the antimicrobial catheter lock solution unveiled to help stage a fight against the CRBSI in hemodialysis patients.