CorMedix Inc (CRMD)

[Lazerking40]

I really don't like playing this "when will it be approved game" cause everyone gets too ramped up about made-up timelines. The company didn't really guide anything specific, and didn't leave room for error. For instance, API supplier #1 provided FDA responses and changes, but that doesn't mean FDA accepted. With that said, the absolute best case scenario I saw was (assuming everything goes well), is possible approval in September. Request meeting mid March, FDA responds early April (14 days), Meeting early May (30 days), prepare and resubmit NDA class 2 early to Mid July (2 months rough estimate not guided), FDA approves early to mid September (60 days). This is best case and assumes no new on site inspection of existing manufacturer. If inspection is required, move from Q3 to Q4. As far as new CMO, figure summer 2024. My best guess and I am no pro. Good luck.