The biopharma firm has been focusing on developing and bringing products to market for treating patients with infection and inflammation. CorMedix currently is focusing on launching its flagship drug Neutrolin in the US. It’s worth noting that the drug has already got approved in the European region and is already sold in the European Union and the Middle East for various indications.
Shareholders would be interested in knowing how the approval process in the US is coming along. Recently, CorMedix has completed Phase 3 trials for Neutrolin and is currently discussing with the Food and Drug Administration (FDA) for the future course of action.
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Neutrolin protects patients who are using catheter from bloodstream-related infections while undergoing dialysis for the treatment of end-stage renal diseases. The ongoing trial is called the Catheter Lock Solution Investigational Trial or LOCK-IT-100, which is going to be a game changer for the micro-cap firm if it gets the nod from the FDA.
CorMedix estimates the annual demand for catheter lock solutions for hemodialysis patients in the US to be between 30 million to 40 million vials. Neutrolin would get 10 years of market exclusivity post the approval, which would be the ideal target for the firm.
Last month, the company updated about the meeting with the FDA on the Phase 3 trial results. Since the biopharma firm has only submitted preliminary data earlier, it needs to send the full data for the regulator’s analysis.
CorMedix plans to send the data to the regulator within the next few months. However, the company didn’t update much on the progress it had during the meeting for filing a new drug application (NDA). The most important update investors would be looking for tomorrow will be relating to the progress of the NDA filing.
It’s worth noting that normally the US FDA requires firms to conduct two clinical trials to understand the safety and efficacy of the product before giving its nod for marketing. Hence, investors are skeptical whether the drug regulator would give the go-ahead for Neutrolin considering it has completed only one trial.
From the company’s point of view, the earlier it hits the market, it would be better for the firm to report profits on a sustainable basis. Any delay in product launch means CorMedix needs to arrange for funding to run the operations without any friction and investors need to wait for maybe a year or two for the firm to deliver results, hoping the drug gets approved.