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CorMedix: CRL Resolution Likely

Apr. 10, 2021 1:42 PM ETCorMedix Inc. (CRMD)12 Comments


  • Today we look at CorMedix, whose shares have had a wild ride thanks primarily to the CRL it received from the FDA around its primary drug candidate.
  • The CRL is likely to be resolved, but does that mean investors should buy the dip in this stock?
  • A full analysis on CorMedix and our view on that question is provided in the paragraphs below.
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Genetic engineering concept. Medical science. Scientific Laboratory.
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This article was written by

Bret Jensen profile picture

Bret Jensen has over 13 years as a market analyst, helping investors find big winners in the biotech sector. Bret specializes in high beta sectors with potentially large investor returns.

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Comments (12)

Bret Jensen profile picture
CorMedix (NASDAQ:CRMD) has met with the FDA to discuss solutions to the deficiencies identified in the Complete Response Letter (“CRL”) to its marketing application for DefenCath™ (taurolidine/heparin catheter lock solution).
The discussions have also involved the third-party manufacturer (“CMO”) who was cited by the FDA in the CRL after a review of the records.
As required by the FDA in the CRL, the company has agreed to a protocol for the manual extraction study for confirmation of in-process controls.
The study is expected to indicate that the labeled volume can be consistently withdrawn from the vials. The company anticipates fulfilling the requirement within several weeks.
In early March, CorMedix dropped sharply after announcing that the FDA has declined to approve its marketing application for DefenCath™ (taurolidine/heparin catheter lock solution).
@Bret Jensen So yesterday's precipitous drop is due to the need for a manual extraction study? Seems to confirm your thesis regarding the probable need for additional dilution.
Bret Jensen profile picture
@JoshE Does seem that way
@Bret Jensen
Any idea when the Fda could approve defenccath
Great article, thanks.
Bret Jensen profile picture
@herwilagn YW. Glad you enjoyed it.
I would like to know at what price Bret was placing on a vial, I have worked in health caree and wife was a cost accountant for hospital group we think CRMD should get 10 to 12$ per vial and with ER numbers added this should be a billion dollar per year in sales by 2025 if they get FDA approval by say SEPT.
Chimpanzee ate my face profile picture
When is a CRL resolution going to be likely for Acadia? Should we double down at these levels? Thanks.
Bret Jensen profile picture
@Chimpanzee ate my face Don't think ACAD gets CRL resolution without further studies. Still has room to grow Nuplazid sales based on approved indication and off label use. I added using covered calls.
Reason given for the CRL sounds so familiar and so often these days. Just a few days ago, PRVB, a co developing a drug to delay/haul the emergence of T1 diabetics was halted for similar reason for using a different supplier of drug manufacturing before the FDA approval date in June. Sounds like these concerns could have been provided to biotech cos much earlier, particularly for those applicants with breakthrough and priority designations FDA had given. Both are trading at more than half of its high with significantly efficacy proven in trials meeting critical medical needs. Puzzling!
everything is right about the drug but seems like just bcz FDA couldn’t make physical inspection, it threw a little tantrum of small couple things in CRL. If the stats are true, this should be approved in an instant. So many people are dieing due to CRBSI & $$ spent in treating CRBSI is huge.
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