I agree with you also, and my post was not intended to suggest that I don't think it will be SOC or profitable or that a major player won't use. Just seems like we can't win here. Every positive gets flipped on its head. We get a good piece of news and almost always the "yeah, but..." crowd wins. until all the unkowns are known, it will be used as ammo against us longs. If they do announce the reimbursement amount, (and please god, I hope I am wrong, but I don't think that will come until June) they need to at least say they are in deep discussions with providers or nearing agreements with providers or at lease getting positive feedback from providers. I know we have a winner here. But for the life of me, I can't figure out why the institutions don't feel the same. I kind of thought we would be around 60 or 65% ownership by now. And I have a really hard time thinking I am smarter than they are.

I agree with you. If they don't know yet they should have just said it's under negotiation or something. They just left everyone hanging. I do think it will be SOC with TDAPA though. No matter what the pricing is it will still increase revenue for any provider while at the same time reduce infection rates. They are judged by CMS on infection rates and rewarded or punished accordingly so they will all want it.

I don't comment much over there, but I watch and listen. You all are super smart and knowledgeable, and I am just a little guy. I saw the PR and quickly skimmed looking for the reimbursement amount. When I didn't see it, I read it, thinking I missed it. I don't think anything nefarious is going on, but that is a huge missing piece that leaves the door open for negative thoughts and provides an opportunity for others to push it down. We all think it should be SOC, but at this point, it is not. We know it will be reimbursed, but we do not know how much other than CMS is pretty cheap, so who really knows. We know Frensius and Davita are the 2 major players, but we have no confirmation they will buy. Everything looks good, and the puzzle is coming together, but without knowing how much they can make and who has agreed to buy, it just leaves too much room for skepticism. I have been here for 7 years, and I am usually very calm and patient, but I am really frustrated today. I'm so tired of waiting for the next catalyst only to be let down. Sorry for the negatively - it's not usually my thing and I am holding. GL

Anyone here from IV? Wondering your thoughts on no reimbursement rate mentioned for TDAPA news

Time for a 'pause'?? Be happy if it could hold over $6+ while its Moving Average line which got 'lost' catches up..

Gets too far apart and its interesting to see how the share price and MA line seem to want to get back together. And unfortunately, it usually involves the share price being dragged lower..

Disclaimer: finally getting the move we have been looking for. 1st target price: $14 (hemo sector), 2nd target price: $25 (IF they can get the oncology sector)

CRMD new 52 hi

Its all about MARKET CAP vs potential revenues.

Some of us who have been in this for a long time had a market cap of around $600 Million based on 'conservative' guesses for sales/pricing.
Gave me a target price of around $25-30 or so BEFORE the 1-5 r/split, with only 25 Mil or so shares outstanding post the 1-5. But now thanks to the dilution to raise cash, a share count of around 58 Million? Now my target price is down to around $14..

So while a 1-5 r/split has occurred, dilution that doubled the number of outstanding shares took place, the MARKET CAP that we 'guessed' at way back around 2016-2017 hasn't changed, won't change until the company/anal-ysts shed some more light on how things are going, and the anal-ysts update their revenue/profits and market cap 'expectations'..

So yeah, it has room to 'run' to the target price, thanks to the 2 frigging CRLS, the damage done has been to the target price expectations thanks to the dilution..
Good luck..

$CRMD 6 is still only 1.20 pre split
We got more room to run
Keep the positive news flowing Joe

Nice follow through on news breaking 5

https://stocktwits.com/newinvestor07/message/568773658

RMB. well little chance of hurricanes in the NW ..:--). Hope it works out for you .
As you know my wife is a Nephrology PA . She handles catheter infections roughly once every 2-3 months . The biggest demand for CRMD's product is likely to be in the roughly 25,000 cases I think of emergency dialysis in a hospital setting each year ...rather than in the routine dialysis clinic setting .

We are more interested in UNCY and ARDX for treating high serum phosphorus. Most of my wife's patients can not get to goal on the current meds ...pill burden and they hate the taste . ARDX has developed a pill taken twice a day but 50% experience diarrhea getting used to the drug. UNCY has developed a " condensed " version of an existing binder thats 1 pill a day with meals ..swallowed .
FDA has delayed approval requesting a tolerability trial with dialysis patients

https://ir.unicycive.com/news/detail/55/unicycive-therapeutics-reaches-alignment-with-the-fda-on

Respond to me on the UNCY board if you want more details

Kiwi

How big is the sales team and infrastructure supposedly trying to sell this in Europe compared to the organization they have in the U.S.?

Yep still here Kiwi. Have been totally distracted with this move to Pac NW.

If they can't sell it in the EU in any volume , what makes you think they will do any better in the US ?
Kiwi

By all means, the company faces a binary event now as it did in 2019 (when this article is from). However, I don't see how the article you refer to brings any information of value at the companys current situation.

https://nightmarketresearch.com/cormedix-infected-with-hype-valuation-swollen/

Kiwi

RMB. Are U still in this ? I'm probably starting a position tomorrow
Kiwi

Actually some one is watching ...my wife rounds dialysis clinics
PDUFA Nov 15
Kiwi

3.92 https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172236480&txt2find=crmd

$CRMD CorMedix Inc. Announces Pricing of $40 Million Public Offering of Common Stock and Pre-Funded Warrants
https://www.stocktitan.net/news/CRMD/cor-medix-inc-announces-pricing-of-40-million-public-offering-of-ouik9129vz5d.html

https://finance.yahoo.com/news/cormedix-inc-announces-proposed-public-200700586.html

See no one watching.... yet just slowly keeps rising.... my largest holding and enjoying the option money every month!!! And the rising price is NICE!!

well.... hasn't been great.... but as of late... money to be made buying on dips and then selling close in options... like at if next Friday still above I'll be making 12-15% on stock I bought .... some will only be about 2 weeks old.... these were extra shares bought believing it will be 5 next week.... wish I even bought more... do have some that I covered with June 6s and 7s that could work out good!! Bulk waiting for a good move up from here!!

Good luck!! Earnings on 15th

Could this has traded poorly since the announcement. Disappointed. Dilution could be the reason and market not happy about extended time frame.

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.

News out AH today that the primary CMO has completed the corrective actions from the FDA
2022 inspection. Anyone now how soon now until approval or when the FDA will
reinspect the CMO facility and assuming it passes, how long until FDA approves?

Moving nice today!!! Up 7.41%!! Have another much hotter today ... but with the target here Happy to see it moving.... just Sold March 6s options. Love to see them take it from me at that price in 17 days!!! Have more not optioned!! They need $6.10 just to break even!!

Great day today.... well so far!!

Let's hope Joe can get this across the finish line.

Slowly creeping back up...... trying to. Just a little today .... hoping for lunch time pull back....

Price far below JMP target of 14 !!!

CRMD broke over 4 today!!! Nice move....

reslabrat...thanks for the info...and best of luck to all

Yeah, saw that. Good news for sure. Hoping we can finally get past that FDA hurdle and we are golden

NTAP Approval

This was posted today in the CMS FY 2023 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule — CMS-1771-F Aug 01, 2022 Medicare Parts A & B.

"Applications for NTAP Approved for FY 2023"

"CMS also conditionally approved one technology under the alternative pathway for products that received FDA Qualified Infectious Disease Product (QIDP) designation that otherwise meets the alternative pathway criteria, but has not yet received FDA approval."

Maybe this is the NTAP approval for Defencath.

great news today...i bot more....burp

to me its a slam dunk...all in my opinion

just makes sense.

best to all

Company announced resubmission of defencath NDA this morning. No reason this should be under 10. Are their any short positions?

CorMedix to Participate in Upcoming January Conferences

BERKELEY HEIGHTS, N.J., Jan. 04, 2022 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that CorMedix management will be participating in several upcoming investor conferences in January.

Investor Conference Details

LifeSci Partners – 11th Annual Corporate Access Event
Wednesday, January 5th – Friday, January 7th
To register and submit one-on-one meeting requests, Click Here

H.C. Wainwright Bioconnect Virtual Conference
Monday, January 10th – Thursday, January 13th
To register for the conference, Click Here

Biotech Showcase Virtual Conference
Monday, January 10th – Wednesday, January 12th
To register and submit one-on-one meeting requests, Click Here

About CorMedix

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The Company is focused on developing its lead product DefenCath™, a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product (QIDP), and the NDA received priority review in recognition of its potential to address an unmet medical need. QIDP provides for an additional five years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA. CorMedix also committed to conducting a clinical study in pediatric patients using a central venous catheter for hemodialysis when the NDA is approved, which will add an additional six months of marketing exclusivity when the study is completed. The Company received a Complete Response Letter from FDA stating that the NDA could not be approved until satisfactory resolution of deficiencies at the contract manufacturing facility, including in-process controls for the filling operation. CorMedix also intends to develop DefenCath as a catheter lock solution for use in oncology and total parenteral nutrition patients. It is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with programs in surgical sutures and meshes, and topical hydrogels. The Company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers. Neutrolin® is CE Marked and marketed in Europe and other territories as a medical device. For more information, visit: www.cormedix.com.

Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
(617) 430-7576

At some point this will be FDA approved..the need for the product is off the map..the question remains..wtf is holding this up?

The stock was upgraded to 32 dollars just before the FDA approval was to be granted..Hoping for 12 dollars on a buyout is ridiculous.

Patience will pay off here.

As I said a few days ago..this is when you should be adding...not talking about selling the company for 12 a share..lol

Hopefully..we'll get an update with some positivity in it...there is an acute need for their products...this is taking so damn long to get FDA approval...

Grease the palms..let's get this done.

CorMedix Inc. to Report Third Quarter 2021 Financial Results and Provide a Corporate Update on November 9

BERKELEY HEIGHTS, N.J., Nov. 02, 2021 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: 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 will report its financial results for the third quarter ended September 30, 2021, after the market close on Tuesday, November 9, 2021, and will host a corporate update conference call at 4:30pm Eastern Time.

Tuesday, November 9(th) @ 4:30pm ET
--------------------------------------
Domestic: 877-423-9813
International: 201-689-8573
Conference ID: 13723602

I hope the CRMD BOD decides to place the company up for sale so the
production, marketing, and sales of this life-saving product can be
done by management that actually know what they are doing...I'd rather
take $12 today than have to wait years for a uncertain amount way out
in the future. Meanwhile, each day that goes by is one less day of
patent life protection.

Now is the time to be loading.

Good Riddance to the CEO...Hope the interim CEO will consider selling
the company NOW instead of hiring a new CEO. One would think someone
on the BOD would have connections to initiate some interest by a BP
that could perhaps even manufacture the product themselves!

The bigger issue is IF this CMO doesn't get its act together (reg compliance), it could lose its fDA cert to be a CMO...

But as someone who has done 'supplier' qualifying audits, there are all kinds of 'things' that can go wrong..

The question is, what are the 'issues', and are they in the category of, we can't manufacture anything cause we can't be trusted to put out a quality product..

On the other hand, it could be that CRMD is staying one step ahead of the ambulance chasing so called 'legal' firms by being over cautious to not give them any reason to 'sue' (to line their pockets while claiming to care about the little 'shareholders')

yaafah...i totally agree....sad

This announcement today of a further delay with no details is BULLSHIT!

It's like the company is intentionally driving the stock price into the gutter.

Read this BS...no details.


CorMedix Inc. Announces Regulatory Update

BERKELEY HEIGHTS, N.J., Sept. 07, 2021 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today provided an update with respect to its resubmission timeline for the DefenCath New Drug Application (“NDA”). CorMedix has encountered delays at its third-party contract manufacturer (“CMO”). The Company was informed by the CMO that there are issues that are unrelated to DefenCath manufacturing activities. The timeline for CorMedix and the CMO to address deficiencies at the facility that are required for resubmission of the DefenCath NDA is uncertain at this time. We will provide an update when more information becomes available.

About CorMedix

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The Company is focused on developing its lead product DefenCath™, a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product (QIDP), and the NDA received priority review in recognition of its potential to address an unmet medical need. QIDP provides for an additional five years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA. CorMedix also committed to conducting a clinical study in pediatric patients using a central venous catheter for hemodialysis when the NDA is approved, which will add an additional six months of marketing exclusivity when the study is completed. The Company received a Complete Response Letter from FDA stating that the NDA could not be approved until satisfactory resolution of deficiencies at the contract manufacturing facility, including in-process controls for the filling operation. CorMedix also intends to develop DefenCath as a catheter lock solution for use in oncology and total parenteral nutrition patients. It is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with programs in surgical sutures and meshes, and topical hydrogels. The Company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers. Neutrolin® is CE Marked and marketed in Europe and other territories as a medical device. For more information, visit: www.cormedix.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects, future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the results of our discussions with the FDA regarding the DefenCath development path for marketing authorization; the resources needed to secure approval of the new drug application for DefenCath from the FDA; the risks and uncertainties associated with CorMedix’s ability to manage its limited cash resources and the impact on current, planned or future research, including the continued development of DefenCath/Neutrolin and research for additional uses for taurolidine; obtaining additional financing to support CorMedix’s research and development and clinical activities and operations; preclinical results are not indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; and the ability to retain and hire necessary personnel to staff our operations appropriately. We continue to assess to what extent the uncertainty surrounding the Coronavirus pandemic may impact our business and operations. These and other risks are described in greater detail in CorMedix’s filings with the SEC, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
(617) 430-7576

That was 5 months ago...

https://ih.advfn.com/stock-market/NASDAQ/cormedix-CRMD/stock-news/85996156/cormedix-inc-announces-regulatory-update

CRMD presents next wed. 4/14.... likely to get update on delay imo.

CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that CorMedix management will present a corporate overview at the 20th Annual Needham Virtual Healthcare Conference taking place on April 12 – 15, 2021.
20th Annual Needham Virtual Healthcare Conference (virtual)
Date: Wednesday, April 14th
Time: 4:30 pm Eastern Time
Webcast: https://wsw.com/webcast/needham107/crmd/2235068

CRMD nice move today..... gap to fill in teens if she can close above 10.