I am still hopeful FDA will accept Class 1 refiling for current CMO and API providors. CMO1 has had 2+ years to address corrections and has snet in all paperwork to FDA for authorization ("all corrective actions stemming from the FDA’s June 2022 inspection have
been completed and the CMO has provided to FDA documentation showing
effectiveness of the corrective actions"). The bigger risk is with API manufacturer who is still finalizing changes requested. But, the problems FDA identified are non-Heparin related according to CRMD (" all corrective actions related to its June 2022 FDA Warning Letter
for a non-heparin API have been completed and implementation is
underway, however it is unclear to the Company based on recent FDA
actions if full resolution of the outstanding warning letter would still
be required prior to approving the DefenCath NDA with reference to API")
Recent news stories on growing alarm of C. auris fungus spreading in hospitals does support why CRMD received NTAP approval before FDA approval and why the FDA should be accelerating it's review of a drug that can dramatically slow the spread of this deadly fungus. Yes, it's the FDA and so nothing is assured, but these alarming news articles should help them move with a bit more urgency.
I am not suggesting a Class 1 path will happen, but at least there's more visibility to the problem and solution to this growing concern so probability of earlier approval might happen. Most importantly, regardless of when we have approval (Q3 '23 to Q2'24), when it happens we should see very rapid uptake.