CorMedix Inc (CRMD)

[Rapture2020]

As if the CRMD tires haven't been kicked enough, I thought I'd take one last look as we head into the Goldilocks zone. My opinion only, and I am not the greatest predictor by ANY stretch of the imagination. The following is for entertainment value only:

1. The FDA previously guided CorMedix to focus on Phase 3 studies to support the filing of the NDA for Neutrolin. THIS IS AN IMPORTANT NUGGET. Why? FDA anticipates that early and frequent communications between the Agency and sponsors interested in pursuing approval under the LPAD pathway for their products can help reduce overall product development timelines.

2. December Meeting. Khoso’s kinda-sorta (at least to me) head-scratching Q3 con call comment about a “PRE-NDA Meeting” with the FDA. A meeting about a meeting? WTF? This is actually a real thing. They won’t be meeting to discuss, nor submitting all required NDA documentation for the full FDA approval. They will be meeting to discuss CRMD’s request for the NDA pathway via LPAD for Neutrolin limited to hemodialysis patients with central venous catheters based on a single study (LOCK-IT-100) during the presubmission/pre-new drug application (pre-NDA) meeting. This is why CRMD has been working feverishly to clean the database. They need the numbers for the meeting, IMO. On 13 November, CRMD reported it was 97% finished. I bet it’s now complete.

3. CRMD will make the LPAD request at the December FDA meeting. Thereafter, the FDA has 60 days max to approve or deny. For example, if the pre-NDA meeting takes place on Friday, 15 December 2018, the FDA’s decision on the NDA pathway via LPAD will be known to CRMD no later than Monday, February 11th, 2019. That’s why Khoso stated he will report the FDA meeting results in the first quarter of 2019.


4. Prediction Time! At the 11 December 2018 shareholder meeting, CRMD will announce one of two things with respect to the pre-NDA meeting: 1) It already took place, or 2) announce the date in December the meeting will take place. I believe it will be the former. I bet the meeting takes place between 26 November and 10 December 2018.

5. Regarding commercialization and how CRMD can capitalize on their technology, it looks as if Medicare/Medicaid reimbursements may likely include Neutrolin (at some level) at dialysis centers beginning in January 2020.

6. And who knows, if the data is phenomenal (knock on wood), maybe a partner appears between the December FDA meeting and the FDA's NDA/LPAD decision in February (or sooner). Oh, and don't be surprised if, as part of the LPAD approval, they may be asked to perform some type of confirmatory trial. Also, LPAD approval isn't always the silver bullet. It's just a bar of silver, a lighter, a brass casing and some gunpowder. Good enough for me, and plenty good for investors.

In the end, we’ll know by Friday, 8 February 2019 as to whether we hit paydirt or not. At least that's my guess.

If it doesn't fall into place, it's going to be a long cold winter, IMO.

If, however, and it's a big IF, everything falls into place (no small feat for a microcap biotech) and approval is granted, we'll all be loving life. Something to think about as we drift off into Tryptophan heaven today. I like to believe CRMD they went through all the trouble to shut down Phase III these past few months because they truly believe they have numbers. At least that's what I hope.

Time will tell!

Good luck all.



TRAAA LAAAAAA LAAAAAAAAAAAAAAAA!!!


Sources:
a.CRMD Q3 Con Call Transcript
b.Reading tea leaves
c.https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM610498.pdf
d.https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm622048.htm
e.https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM610498.pdf
f.https://www.law.cornell.edu/uscode/text/21/356
g.https://www.appliedpolicy.com/medicare-reimbursement/significant-changes-to-esrd-drug-add-on-pricing-and-quality-measures/