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This thing is the biggest tease ever.
i still hold a tiny position here - kinda sad how this has played out - CEO really botched it
* * $CRMD Video Chart 10-16-2019 * *
Link to Video - click here to watch the technical chart video
CRMD bottom reversal http://www.stockta.com/cgi-bin/analysis.pl?symb=CRMD&cobrand=&mode=stock
CRMD~~NEWS~~CorMedix Completes Successful CMC Interaction with the FDA
Pre-NDA Meeting Scheduled
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October 16, 2019 08:15 ET | Source: CorMedix, Inc.
BERKELEY HEIGHTS, N.J., Oct. 16, 2019 (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 completed its interaction with the FDA related to the chemistry, manufacturing and controls (CMC) package that will be needed to support Neutrolin’s new drug application (NDA). The FDA was supportive of Neutrolin’s proposed manufacturing program, including the active pharmaceutical ingredients (API), the container closure and testing, and indicated that it will conduct a thorough review of all of the CMC information as well as assess the commercial readiness of the various manufacturing facilities at the time of NDA filing. No further CMC meetings with FDA are planned prior to NDA submission.
A pre-NDA meeting has now been scheduled and CorMedix is looking forward to discussing with the FDA the filing of the NDA for Neutrolin®, including the FDA programs intended to facilitate and expedite review of the application, such as Priority Review designation, rolling submission, and LPAD.
Khoso Baluch, President and CEO of CorMedix commented, “We are very pleased with FDA’s feedback on the CMC package and with the scheduling of a pre-NDA meeting. We are continuing to move forward with preparations for the filing of the NDA for Neutrolin in accordance with our plans, which are focused on obtaining an approval for Neutrolin in adult hemodialysis. We anticipate that Neutrolin can be approved in the second half of 2020 and we intend to launch Neutrolin commercially in the US promptly after its approval either by ourselves or with a partner.”
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 Neutrolin®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters, currently in Phase 3 development for patients undergoing chronic hemodialysis. Such infections cost the U.S. healthcare system approximately $6 billion annually and contribute significantly to increased morbidity and mortality. Neutrolin has FDA Fast Track status and is designated as a Qualified Infectious Disease Product, which provides the potential for priority review of a marketing application by FDA and allows for 5 additional years of QIDP market exclusivity in the event of U.S. approval. Neutrolin is already marketed as a CE Marked product in Europe and other territories. In parallel, CorMedix is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with active 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. 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 information, costs and time needed to submit to the FDA a new drug application for Neutrolin in adult hemodialysis, including; risks related to obtaining FDA approval of the new drug application for Neutrolin; relying on preclinical results that may not be indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; the risks and uncertainties associated with research for additional uses for taurolidine; 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 Neutrolin and research for additional uses for taurolidine; obtaining additional financing to support CorMedix’s research and development and clinical activities and operations; and the ability to retain and hire necessary personnel to staff our operations appropriately. 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
617-535-7746
looking good today, 5's the bottom
the reverse split's done well for the dilution.
It’s kinda sad but expected. In December 2017 when Khoso and Chew started changing their tune and started talking not about a pre NDA meeting, but PRE PRE NDA meeting, it made me leery.
Pushing NDA into mid 2020 tells me Khoso and Chew Were being duplicitous about the time line, or worse, the FDA may actually have concerns about the CRO SNAFU and the ensuing stellar P value.
I hope my opinion is dead wrong. Either way I may take a position in Jan or Feb. I honestly don’t know where it will be trading, but I can now see $2-3 or worse
Sad. Good luck to you.
dang, rap, you called this one
Hi, I am your new bagholder ...
I stayed liquid throughout and then bought at 5.50 about.
Should see further selling, as I average down at 10AM ish tomorrow.
Is this a major buying opportunity or is this thing going to tank even more?!? Remember when I called it a dumpster fire and you said no way. I feel I need a strong drink and a good think.
I don’t see a near term catalyst so I anticipate a slow drift south for the next 6 months. There will be spikes from time to time but absent a buyout or partnership, which I don’t anticipate until after NDA submission (at a minimum).
I’d you are invested and don’t mind the wait, grab a cold corona and let it ride.
This will likely trade in the $3-$4 range before it trades in the $10 range. If Tutes keep buying to prop it up. Then I bet it may trade in the $4-$5 range until news gives it a boost.
That said, I do think 2020 is finally the year and could easily see this going beast mode the second half of 2020.
Good luck to you.
What happened today?!? My dog had a relapse with his congestive heart failure so out of the loop but it looks ugly. Or time to load the boat. Thoughts?!?
Yeah i didn’t factor in Tute buying. It’s increased since last year so the likely in the $5 range. Hope I’m wrong.
If you'd pardon my 2 cents ...
The SP shot through the $1.54 (pre-split) support level. $1.54 times five (1-5 RS) = $7.70... So $7.50 was going to be my next buy-in.
SHOT RIGHT THROUGH IT so it didn't happen.
Yesterday's warrant announcement now put me at a new level of support which would be $5.75 because that's what the chart depicts. Just a common traders mentality among'st us technical analysis technicians.
But there is a catch .. is this a sour news before a good news shake?
And will CRMD pop before SESN? All good stuff.
Oh, and one foot note (pun intended) CRMD is being fast tracked.
Bodes Well
250-300 range? you are really bearish
Eject sequence initiated in early August. Now an NDA decision not until second half of 2020? WAFJ. I made a killing on this since April 2018, but call options were terrible, lol.
There is no secret buyer, IMO; Elliot continues to enrich themselves; and no NDA decision for at least another 9 months??? The opportunity cost for parking money here for all that time? No thanks.
I wouldn’t at all be surprised if CRMD has another offering or fires up the ATM in Jan-Feb 2020. Absent a partnership or buyout (not likely, IMO) I could see this settling in at $2.50-$3.00 for the long winter nap.
Given the urgent need of a drug to combat hospital catheter infections, I’m starting to wonder out loud if the FDA is double, triple, and quadruple checking the data, given the insanely high P value—particularly after the CRO catastrophe.
I have a small position so I hope I’m wrong. For now, on to greener pastures. I’ll likely take another look in the spring of 2020.
Good luck Janey!
wow people are just shitting all over this stock
Any meaningful news from this bunch of yokels would be great
Not buying anymore until this bottoms out somewhere around 6.00
From their last 10Q about patent infringement by TauroPharm, "An oral hearing has been scheduled for September 17, 2019."
It also mentions a hearing on Sept 6th. Not sure which date is final.
http://irdirect.net/filings/viewer/index/1410098/000165495419009628/
More news soon?
Agreed. I kept my initial position in the event of partnership or BO but pulled the rest.
Don’t expect catalyst until 2020. Chew and Khoso played fast and loose with possible LPAD dates last year. Shame on them, IMO.
Wouldn't be a surprise if we saw it coming. Lots could happen, massive buyout, big Pharma pays huge premium, partnership, who knows. But nothing really expected till early next year.
and no real chance for some kind of upside surprise between now and then either
According to Q2 transcript FDA meeting in 4Q 2019 to discuss CMC information in prep for preNDA meeting. Probably nothing big released till after that. Probably not much then either. No big news till after the pre NDA meeting early next year.
kinda getting the doo-doo treatment here lately - crmd needs some news soon. investors are just getting tired of waiting around
getting interesting now..
Thought the CC went well, nice update on things. Then this activity..
Sounds like the pieces are 'coming together'...
Question is, what will the final 'picture' look like... (although $8 pre-split was my original target as they moved towards approval, would like to see $20 now as a minimum for holding)
Cormedix enters Exchange Agreement with Elliott Associates
Looks like CRMD is cleaning up the company shares. Might be to make the company more attractive for either a partnership or buyout. Wonder if something is in the works.
Janey - I don't agree but many do seem to have that opinion. Good luck to you!
My quick take on yesterday's call:
Perfect call for institutions IMO. Retail hears a year before NDA, tutes hear very high likelihood of success with no need to raise capital.
No comparison whatsoever, but think Tesla or Beyond meat. Yes they have revenue, but they loose cash consistently. Tutes are heavy here cause they know (or have a great expectation anyway) that the future is bright. When do the huge drops happen.....capital raises. Tutes are going to be more than happy to let retail panic, day traders do their thing, and let shorts play while they steadily accumulate. I really believe we are heading into a new territory in the next 6-9 months (maybe sooner) when tutes will determine the stock volatility and not retail. Does that mean we get rich today or tomorrow...no. The PPS can go way up or way down....if I had to guess, I would bet it will do both at some point. Perfect for day traders..... that's just not my game and I won't try to guess near term fluctuations.
But what I do think.
1. CRMD is highly confident, that is obvious.
2. Why the little anecdote about bringing in a more experienced, BF type player to partner with oncology? I think they have a plan in process.
3. My valuation has only increased. Just the 40M hd locks is huge.
I am, have been, and remain bullish. Everything above are my opinions only. Notice I said "think or believe" a lot as I don't know anything!!!
Good luck all!
Short answer is no, but things to consider about Cormedix and other similar companies. There is a relatively high retail investor presence with high expectations of what is going to happen tomorrow or today or in the next hour. Many are playing with scared money and sell when they start seeing a down trend or start Cadillac shopping when there is an uptrend. This makes the stock prone for big swings inviting day traders to the party. This creates great opportunities for shorts to play the game. Most wild pre and post movement swings are on a few shares. Is this MM sending signals to each other, a retail investor scared and dumping his/her 50 shares, or a retail investor buying way to high cause sticktwits says it's going to the moon? Who knows, but I don't care about meaningless swings myself. This type of movement will only stop once the volatility slows or there is a much higher institutional stake. Tutes seem to be buying in Q2. If their holdings can eventually get to 50% or so, the games you see will slow. Right now, I think everyone can make money here.....traders, shorts, and longs......pick your poison. I am staying long cause that is all I do. All just my opinions. Good luck to you.
Can anyone make sense as to how ghost gets traded up and then the bottom falls out of it. Happens time and time again lately.
Regardless of market reaction that I won't even try to guess, I thought this was a very positive call and am pleased with the update. The most important thing to me is their current cash position. If a buyout is going to happen, will be in next 12 months.....If not, seems we have a clear path to US distribution. Almost makes me want to buy more! Just my opinions! Good luck all!
almost exact same report for Q2 2018 - WTF
And we find ourselves once again at one of the the most overhyped yet underwhelming days of the year.....the quarterly update. The day where it is revealed that some random small cap company ( in this case, Cormedix) has been keeping huge secrets of success waiting for this very day to announce stock spiking FDA or buyout news. Anyone who knows me knows I am a CRMD bull, but big spikes on earnings day is generally for companies with earnings! Yes, I hope some big reveal will come forth and push the PPS to $50, but my expectations are tempered. Let's hope the cash burn hasn't exploded while they work through FDA approval, let's hope for a little more clarity on already known FDA approval guidance, and let's hope they don't need cash in the forseeable future.....but I am not going to assume they are withholding information to reveal today. That's how shorts win after most small cap quarterly updates. Preying on the vulnerable hoping for a miracle. Good things are coming and I am long and bullish here! If you are a trader, then yes, you should pay attention.....if you are long, relax and enjoy the ride on the longest bumpiest road in the word in our Cormedix bus with no shocks!! I know there is no real pertinent info in this post and everything is just my opinion.....just had to get this off my chest. Good luck to all!
I dunno. Management can’t seem to pull their heads out of their asses long enough to generate value to shareholders. Last year and early this year were great. Right now, this blows.
for anyone w cash on the side - this is a yuge oppy
Thanks Rap! Hadn't seen that article. GLTU
Why yes ... yes it does. I've just been getting anxious. Cup and handle aside I just want to know when we can raise our glasses and celebrate lol.
Would you call that a cup and handle since April?
When is this thing going to get some legs and take off. Watching my grass grow is slightly more exciting lol.
News: $CRMD CorMedix Presents at FDA Public Meeting on the Limited Population Pathway for Antibacterial and Antifungal Drugs
BERKELEY HEIGHTS, N.J., July 17, 2019 (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, announced today that Dr. P...
Find out more CorMedix Presents at FDA Public Meeting on the Limited Population Pathway for Antibacterial and Antifungal Drugs
CorMedix Presents at FDA Public Meeting on the Limited Population Pathway for Antibacterial and Antifungal Drugs
https://finance.yahoo.com/news/cormedix-presents-fda-public-meeting-121500555.html?.tsrc=applewf
@hmuney Yes, Phoebe Mounts is presenting July 12th. Scroll down she is listed towards the end.
Public Meeting: Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD Pathway)
July 12, 2019 9:00 AM – 12:00 PM
U.S Food and Drug Administration White Oak Campus
Building 31, Room 1503 - Great Room 10903 New Hampshire Avenue Silver Spring, MD 20993
ABSTRACT
This meeting is to hear public comments on the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway) draft guidance. This guidance provides information on the implementation of section 506(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356(h), added by section 3042 of the 21st Century Cures Act.
Each public presentation is allotted 10 minutes. Five minutes are allotted following each presentation to offer an opportunity for the panel to ask clarifying questions. Please note that times may vary based on participation and other logistics and are subject to change.
8:00 AM – 9:00 AM 9:00 AM – 9:20 AM
9:20 AM – 9:30 AM 9:30 AM – 9:35 AM 9:35 AM – 9:45 AM
9:45 AM – 9:50 AM 9:50 AM – 10:00 AM 10:00 AM – 10:05 AM 10:05 AM – 10:15 AM
10:15 AM – 10:20 AM 10:20 AM – 10:30 AM
Registration
AGENDA
10:30 AM – 10:35 AM
Introductions and Opening Remarks
Ed Cox, MD, MPH, Director, OAP, OND, CDER, FDA
Public Presentation: John Rex, M.D. Chief Medical Officer, F2G Ltd.
Questions
Public Presentation: Thomas Walsh, M.D., Ph.D., Professor of Medicine, Pediatrics, Microbiology & Immunology, Cornell University
Questions
Public Presentation: Phoebe Mounts, Ph.D., General Counsel, Cormedix
Questions
Public Presentation: Colin McGoodwin, Infectious Diseases Society of America
Questions
Public Presentation: Jack Mitchell, Director of Health Policy, National Center for Health Research
What is YOUR Problem Lady!(I apologize to the Real ladies). You start out calling me a DOUCHE & I was right about News this week. Then you give me Grief for saying I was Correct and NOW you have the NERVE to call me a Braggart because I bought this stock over a year ago at .35. You are a Real Piece Of Work, also known as an AssH*$#.I will not be responding to an Imbecile like you Ms. Classless going forward!
Can anyone confirm if Phoebe Mounts is presenting this Friday (7/12) at the FDA LPAD Public Meeting?
https://www.federalregister.gov/documents/2019/04/02/2019-06390/limited-population-pathway-for-antibacterial-and-antifungal-drugs-public-meeting-request-for
The Eventbrite link below is directly from the FRN page linked above:
https://www.eventbrite.com/e/limited-population-pathway-for-antibacterial-and-antifungal-drugs-lpad-public-meeting-tickets-54015228001
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