CorMedix Inc (CRMD)

[Lazerking40]

Been long 4 years and will stay long, but not blind to the reality that there is a bear and a bull case here.

FDA says they want more info from manufacturer and a manual study to make sure right amount of defencath is extracted from viles. Without a CC we are left to guess what that means. My assumption is the manufacturer didn't provide a strong enough case that their control procedures are in place to ensure proper vile fill up. So FDA says prove you are putting the right amount in each vile and then prove there is a back up by ensuring the proper amount is extracted for use so we are sure the manufacturer isn't shorting or overfilling viles.
Just my guess.

My thoughts:
1. Easy fix for sure
2. Easy doesn't mean quick. It takes 45 days just to schedule a meeting.
3. That April meeting is REALLY important. There is a chance CRMD will need to remedy the issues and then file a new NDA. This is worst case scenario. That get us to Q4 2021 / Q1 2022.
4. Best case is Q3 2021. Without a whole new NDA filing.
5. Capitol Raise..... probably not, but they really like that ATM. IF a new NDA is needed, that is bad! They would need money. This is where investors struggle. When a company says they have enough money for 1 year, they need to raise pretty quick. Can't run the bank account to zero.
4. I am figuring in about a 10% dilution now into my own spreadsheet I keep by Q1 2022.
5. The bulls have had control of the price the past few weeks, now control appears to be with day traders. If control move to bears, look out.
6. $8-9 is a good buy in my opinion, but would not be surprised if it goes down more.
7. I am thinking short term (1-6) month bear case and long term bull case as of this minute. CRMD management can change my opinion with a simple conference call.....but the lack of a call signals a lack of a plan.
8. Then again, I could be full of crap and they fix everything in 2 months and we are off to the races......this would be fantastic! Still long, will buy more at some point.
Final note from me:. Really disappointed with the company. They took their time with the excuse of crossing all t's and dotting all I's yet here we are. These are my opinions only.

[voisybay123]

Dr. Balauh has already pointed out that they have $88 million in funds on the books to cover operations until Q42022--stop this "dilution" baloney already-and approval will be later this year--why would a manufacturing glitch take a whole year to settle (COVID or no COVID)

[DavidW2]

Manufacturer & label issue will take at least 6-12 months to resolve.

I think another PUFTA date in February, 2022. In this case, yes. company will dilute again later this year (most likely 4th quarter this year).

[Teivel]

Good point..I took advantage of the selloff and more than doubled my position today...the wild card is we don't really know how long we'll have to hold to capitalize on DefenCath.

It bothers me that it is approved for use outside of the USA....and at the 23rd hour this glitch magically appears....right before FDA approval here.

I am having a hard time blaming the company for this.

I personally believe this is FDA meddling for whatever reason.

[namah sivaya]

Don’t discourage maybe we’ll get some more stupid selling tomorrow morning. Guys like this are our friends :)

[ClayTrader]

* * $CRMD Video Chart 03-01-2021 * *

Link to Video - click here to watch the technical chart video

[Teivel]

Did you even read the press release?

This is right out of it:

"CorMedix ended the 4th quarter of 2020 with pro forma cash, cash equivalents and short-term investments of approximately $87.8 million, including capital raised though ATM issuance, which the company estimates is sufficient to fund operations at least into second half of 2022."


Why are you talking about dilution right now?

Ridiculous.

[DavidW2]

CRMD will have another dilution before FDA approval. Approval might come in year 2022. Forget about this year...

[voisybay123]

and what is the likelihood the company has the funds to get to approval now without another crummy dilution?? I'm staying on the "sidelines" about buying more shares--if I buy 1000 SHARES I bought 1000 shares--PERIOD--I'm not going to bother with 100 or 50 shares after another dilution

[Teivel]

There is nothing wrong with DefenCath..it's the delivery system...and the manufacturer....

This is on Cormedix...they should have made sure everything was proper.

Now this whole process will be delayed.... and further delayed because of

Covid and the backlog the FDA needs to get through.

I just took advantage of the opportunity to double my position.

Not giving up on this ticker by any stroke of the imagination.

But a delay is inevitable now.

Meeting requested with the FDA in April sometime.

[thumper1]

ouch

[Teivel]

Was expecting some kind of announcement today on the FDA filing...so far nothing and the share price is getting pummeled once again.....go figure.

Guess the market makers want to see how much pain we're prepared to endure.

I'm not selling.

[Expresso123]

BlackRock Inc. ownership in CRMD / CorMedix Inc.
2021-01-29 - BlackRock Inc. has filed an SC 13G/A form with the Securities and Exchange Commission (SEC) disclosing ownership of 1,995,193 shares of CorMedix Inc. (US:CRMD). This represents 6.2 percent ownership of the company. In their previous filing dated 2020-02-07, BlackRock Inc. had reported owning 1,712,901 shares, indicating an increase of 16.48 percent.

[Teivel]

Kind of hoping they announce tomorrow as the 28th is a sunday.
Usually this is what happens.

[Teivel]

That would be sweeeet!

[Expresso123]

We should be able to hit a high of 42.00

[Teivel]

I think we hit 30's...imo.

[timberwolf7]

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)

[Expresso123]

The FDA has granted priority review for Defencath™ and has set a Prescription Drug User Fee Act (PDUFA) date of February 28, 2021

[Teivel]

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...

[crudeoil24]

$31.00 > PT

[crudeoil24]

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

[Expresso123]

Nice to see you here MjMilo

[MjMilo]

https://www.barchart.com/stocks/quotes/CRMD/opinion

[MjMilo]

https://www.barchart.com/stocks/quotes/CRMD/overview

[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.

[MjMilo]

https://ca.finance.yahoo.com/news/cormedix-inc-nasdaq-crmd-breakeven-075724963.html

[AlphaStockNews]

$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/

[KC01905]

You may have better luck on that board LOL.

[DavidW2]

May I know what is the potential market value of vicineum (SESN)? Thanks.

[thumper1]

as jackie gleason use to say.....

AND A WAAAAAAAAY WE GO

best to all

[proffetti]

Truist Securities ups price target to $35

[proffetti]

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.

[Expresso123]

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.”

[SweatpantKing]

Yeah, there are a lot. Hopefully they can get quick approval for expansion.

[tone3]

Only About a 260m market cap and the market they are selling into is 2 billion

[tone3]

After rereading their press releases they gave many markets for their product. CRMD also lining up people to market the products once approved

[SweatpantKing]

Smooth sailing! Hopefully they start talking oncology as an expansion.

[tone3]

Nice steady climb with decent volume

[tone3]

If all goes as planned 15-20 bucks by February

[whytestocks]

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

[dshade]

solid update. just got the email alert

[proffetti]

Next leg up should be next week

There really shaking this stock up.

[KC01905]

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.

[tone3]

This should get some attention in a overall down day in the market

[proffetti]

Markets down -855 and were rocking baby!

I told ya I told ya! lol

[proffetti]

Forget the handle it's a parabolic move!

[proffetti]

Uh Oh! Cup and Handle Forming!

[proffetti]

We are on our way! up over 21% now

[tone3]

I found the article, thanks. 50 if all the other applications are approved