Recap on company timeline of events

For those who wants a quick buck, probably this is not the place for you now.
This drugs might have the same potential as CCXI Avacopan. Company have address their shortcomings and now only need to submit NDA to FDA whereby no timeline was given yet.

Company submission for NDA was rejected by FDA previously, as there was some issues at the third-party manufacturer, or CMO, manufacture of DefenCath.

The Company received a Complete Response Letter from FDA stating that the NDA could not be approved until satisfactory resolution of deficiencies at the contract manufacturing facility, including in-process controls for the filling operation.

Together with our CMO, we have been able to resume manufacturing activities and are continuing to complete the work that is required to address the deficiencies identified at the manufacturing facility.

Dr. Matt David, CorMedix interim CEO, commented, “We are pleased that we have been able to resume manufacturing activities at our CMO and look forward to providing updates over the coming months. As the recent industry conference presentations have highlighted, catheter related bloodstream infections are common in patients receiving hemodialysis via central venous catheters and are associated with significant morbidity and mortality. We remain steadfast in our commitment to these patients as we seek to bring DefenCath to market upon its approval.” CorMedix continues to work diligently toward the resubmission of the DefenCath New Drugs Application and plans to provide an update when we have clarity on the submission timeline.

6. DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product (QIDP), and the NDA received priority review in recognition of its potential to address an unmet medical need. QIDP provides for an additional five years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA. CorMedix also committed to conducting a clinical study in pediatric patients using a central venous catheter for hemodialysis when the NDA is approved, which will add an additional six months of marketing exclusivity when the study is completed.