CorMedix Inc (CRMD)

[Rapture2020]

Question: On last week's conference call, was it Khoso or Chew who said CRMD was hoping to use the FDA's LPAD (Limited Pathway for Antibacterial and Antifungal Drugs) process to roll out Neutrolin? If that is the case, what's the actual down-time between a meeting with the FDA and submission of an NDA. More to the point, is a traditional NDA--which would burn another 3-9 months--even required if a drug is routed through LPAD?

The article below got me thinking...have I been focusing on the wrong approval mechanism?

CRMD seems to meet the threshold requirements for this process? Now, everyone please feel free to set me on fire if I am completely off base.



https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm622048.htm
FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation

First drug granted approval under FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs, instituted to spur development of antibiotics for unmet medical needs