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still looking for $20-25 IF they get an approval decision (the lack of knowledge on the facility inspection is the wild card in terms of risk)..
anything more is gravy...
and then they will hold a PR and tell us what their plan is for the 'next' phase (sales commencing)
The FDA has granted priority review for Defencath™ and has set a Prescription Drug User Fee Act (PDUFA) date of February 28, 2021
Big move coming as we head into FDA approval....
At least a double from here....
Analyst upgrades move the stock well into the 30 dollar + range...
Very undervalued company...
Cormedix shares are trading higher after Needham initiated coverage on the stock with a Buy rating and announced a price target of $31 per share.
Benzinga
Nice to see you here MjMilo
The story here is very compelling ..waiting for FDA approval...on the 26th of February...
Blackrock increased holdings to almost 7%
Needham just gave a rating of 31 dollars/share.
Currently trading around 15 which is where I entered.
$CRMD is headed for the top as excited investors dive in prior to a coming PDUFA date that comes with a high probability of approval. https://cnafinance.com/crmd-stock-the-cormedix-pdufa-date-is-coming/
You may have better luck on that board LOL.
May I know what is the potential market value of vicineum (SESN)? Thanks.
as jackie gleason use to say.....
AND A WAAAAAAAAY WE GO
best to all
Truist Securities ups price target to $35
Relatively small float @ 32,132,492
This one's going up yes congratulations and the treatment is coming.
It's about time. I hope SESN does the same, both great companies with tremendous potential.
CorMedix Inc. to Begin Trading on the Nasdaq Stock Exchange
BERKELEY HEIGHTS, N.J., Jan. 21, 2021 (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that it has been approved for listing on the Nasdaq Global Market. The company’s shares will continue to trade under its current symbol “CRMD”. Trading on the Nasdaq Global Market is expected to commence on Tuesday, February 2, 2021. The Company’s shares of common stock will continue to trade on the NYSE American until the close of the market on Monday, February 1, 2021.
Khoso Baluch, CorMedix CEO commented, “We are excited to have Nasdaq as our new exchange partner. As a late stage biopharma company, we feel that Nasdaq is a natural fit and already includes many of our peers in the space. With the February 28, 2021 PDUFA date for completion of FDA’s review of the Defencath NDA on the horizon, the year ahead is likely to hold significant growth for CorMedix as we set our sights on becoming a commercial entity in the US. We believe this move will further enhance our visibility in the marketplace, expose our company to a larger audience of institutional investors and ultimately increase liquidity and shareholder value.”
Yeah, there are a lot. Hopefully they can get quick approval for expansion.
Only About a 260m market cap and the market they are selling into is 2 billion
After rereading their press releases they gave many markets for their product. CRMD also lining up people to market the products once approved
Smooth sailing! Hopefully they start talking oncology as an expansion.
If all goes as planned 15-20 bucks by February
Breaking News: $CRMD CorMedix Inc. Announces FDA Decision That Advisory Committee Meeting for New Drug Application for Defencath is Not Needed
PDUFA date remains February 28, 2021 Potentially the first antibacterial and antifungal catheter lock solution in the US to prevent catheter related infections in hemodialysis patients BERKELEY HEIGHTS, N.J., Nov. 18, 2020 (GLOBE NEWSWIRE) -- CorMedix Inc. ...
Got this from CRMD - CorMedix Inc. Announces FDA Decision That Advisory Committee Meeting for New Drug Application for Defencath is Not Needed
Next leg up should be next week
There really shaking this stock up.
Question ... is this going to be a "sell the news day" or are we going to continue our march up?!? Very curious to see how this week goes.
This should get some attention in a overall down day in the market
Markets down -855 and were rocking baby!
I told ya I told ya! lol
Forget the handle it's a parabolic move!
We are on our way! up over 21% now
I found the article, thanks. 50 if all the other applications are approved
Truist Securities initiates at Buy
Looking good foke!!
initiated at $20 a share.
$CRMD $16.44 Million in sales last Qtr.
That's a lot of product being used in Europe. The FDA should have no problem perusing this material and analyzing data. Next Qtr sales should dramatically increase as the new improved treatment is becoming well known. Once the FDA see's what's happening in Europe, approval should come rather quickly. Maybe this year.
First, no need to worry about defending management with me. I didn't start riding this one heavily until it was down around 20-25 cents/sh... And as far as managements actions go? If I decide to stick around with an awareness of what they are doing, then its my 'responsibility' for my decision to do so.
Anyways, share price got the hit, but finally saw a 'buy' signal develop last week (forget the day I posted about it on the IV board). At the time, I picked up around 4000 shares at $4.14, promptly sold the Sept $4 calls for a 'net' gain of 64 cents/sh if I lose the shares at $4 on Septs OE day. (this buy was purely for the gains off the calls). And as that day approaches, I will look at what I paid for the calls, what it will cost to buy them back to close them out, and what I can sell another round for (most likely the $5s if I keep the shares).
And again, if I lose the shares, I am ok with the 16% one month gain...
Good luck...
Not really surprised. Being a long time holder, it was pretty obvious a raise of some kind was coming. Sure they had cash on hand to get to Q2 2021 or whatever it was they said on their last call, but they all say that and you can't run the bank account to zero. Timing of the offering is somewhat unknown, but I think relatively soon and is definitely up for debate regarding what timeline is best. Do it after FDA approval and kill momentum putting shorts in the driver's seat, or right before FDA approval, take the 20%-25% hit to 5 or even 4.75, allow the shorts to load up, then announce FDA approval, get your bounce with the added bonus of a short squeeze. And maybe drive it to 7.5 or 8.... maybe higher if a squeeze does happen? I don't have a clue what they are thinking, but at least this isn't an Elliot sweetheart deal or a double warrant laden crap deal from what I can see. This does feel a little different than past raises and I for one am hopeful.....not bullish enough to recommend a buy, but bullish enough to hold and possibly buy more........And no, I am not an apologist for this company or management, just trying to understand leaving emotion on the sidelines. Good luck!
well, with around 25 Million shares available for trading, and what looks like a 'go it alone' stance from management, they want to sell 10 million shares to raise $50 Million to get things going?? I don't like the hit to the 'top line share price', but if they make it to a market cap of $1 Billion,
I will take a share price of $28 with 35 Million shares outstanding vs $40 with 25 Million...
still a pretty nice return... especially if it helps them get to $28/sh...
CorMedix Announces Proposed Public Offering of Common Stock
BERKELEY HEIGHTS, N.J., July 27, 2020 (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE American: CRMD) (the "Company"), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, announced today that it plans to offer shares of its common stock in an underwritten public offering. In connection with the offering, the Company intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the size or terms of the proposed offering.
The Company plans to use the net proceeds for general corporate purposes, including obtaining regulatory approval and commercialization of Defencath(TM) in the U.S., research and development, and working capital and capital expenditures.
After hours has not had a favorable response, probably because of dilution concerns.
News: $CRMD CorMedix Inc. Reports Submission of Defencath(TM) New Drug Application
BERKELEY HEIGHTS, N.J., July 08, 2020 (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that all of the ...
Read the whole news CRMD - CorMedix Inc. Reports Submission of Defencath(TM) New Drug Application
Moving along slowly. 60 days before NDA submission review complete. Then if given priority review another 6 months before approval. Nothing happening fast in the FDA review process.
BERKELEY HEIGHTS, N.J., July 08, 2020 (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that all of the modules for the Defencath(TM) New Drug Application (NDA) have been submitted to the Food and Drug Administration (FDA). Defencath is being developed as a catheter lock solution with an initial indication for use of preventing catheter-related bloodstream infections (CRBSIs) in patients with end-stage renal disease who are receiving hemodialysis via a central venous catheter. The NDA was granted rolling submission and review by FDA as announced previously, and there has been ongoing dialogue with FDA as it reviews the submitted modules. The NDA contained data from the Company's Phase 3 trial, LOCK-IT-100, in patients undergoing hemodialysis for end-stage renal disease, which showed a 71% reduction in CRBSIs relative to the heparin control arm (p=0.0006) with a good safety profile.
The Company requested priority review of the NDA, based on the Fast Track and Qualified Infectious Disease Product Designations granted by FDA to Defencath. The FDA has 60 days to review the submission for completeness to make a filing decision and grant a priority or standard review. FDA will have a goal of a 6 month review period for priority review, compared to 10 months for a standard review.
https://content.seleritycorp.com/hosted2/assets/www/aFAIEVexU3HfOCIj6ORQ1WFxLSTBnqvkQ14RdHnFhJ0ath
The lord giveth and the lord taketh away lol. What a bath today was all around.
Alive and well. Into second half of 2020 and waiting for the New Drug Approval (NDA) from the FDA, according to their February press release. Have not heard anything to the contrary and the pps has been rising so I consider that a good sign that all in on track. I really don't understand why there is not more interest in this stock. Granted they are low key and not a PR machine but looks like a solid company. Time will tell. Should be more action coming.
This thing is still alive?!? Hadn't checked since this whole s%#t storm started.
This was reported back in February. Maybe NDA approval is moving along. We have just begun the second half of 2020.
CORMEDIX INC. ANNOUNCES FDA GRANT OF ROLLING REVIEW OF NEUTROLIN® NEW DRUG APPLICATION
Berkeley Heights, NJ — February 3, 2020 — CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, announced today that the US Food and Drug Administration has granted the request for a rolling review of the New Drug Application (NDA) for Neutrolin® for the prevention of catheter-related blood stream infections (CRBSIs) in hemodialysis patients.
A rolling submission of the NDA is designed to expedite the review process for products being developed to address an unmet medical need. CorMedix remains on schedule for a potential NDA approval during the second half of 2020.
http://www.cormedix.com/cormedix-inc-announces-fda-grant-rolling-review-neutrolin-new-drug-application/
Updated April investor presentation. No big new news but looks like we are getting closer. Still saying FDA approval in 2H2020. Only probable big news between now and end of 2020 would be a new partnership or finance deal. Going to have to come up with dollars to go into production. Be patient.
http://www.cormedix.com/wp-content/uploads/2020/04/Corporate-Presentation-April-2020-2.pdf
Coming back from the hills. Good evaluation of CRMD!
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