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Now that the DSMB has said to conclude the study, CorMedix plans to submit the results of the interim analysis to the FDA for its review. The company will look to add an FDA approval to its CE Mark in Europe that allows Neutrolin to be marketed as a medical device. In post-market studies, Neutrolin was shown to reduce CRBSIs by 96% and blood clots by 96.7% compared to historical benchmarks.
BOOM.
LOL.
No it’s important. I think for day traders, it adds a layer of uncertainty.
I do get a chuckle over at StockTwits. Never have I seen so many people pat themselves on the back for buying a stock.
I think given the news we should still be hitting incremental gains. I don’t expect 25% a day but green much more than red. This is the time to buy and hold, IMO.
As long as we have volume like we’ve had the past week, we should be fine.
Thanks for the update. This is very helpful. I think we should be okay given the
That would be great. Would love it today, of course. Lol.
Speaking of CRO, i wonder if some type of settlement is in the works and when it might be released. I’m thinking maybe earnings in the 8th?
Perfect! Thanks for the update.
Holding for the back 9. This is going to be one for the books.
Was she brought in to assist with commercialization?
You too. It’s been one hell of an enjoyable ride. I don’t the steam is going to let up just yet.
AH was solid. Have a nice evening.
And then the homeowner says:
“that’s a great idea! and then you pay half my annual rate increase asa result of this fake filing, even if I change houses, until I pass away, because I’ll still be using the same insurance!”
Then the crook says: “Done deal, provided you pass through any reduction of annual rates said insurance company may offer for not filing a claim against them over time?!”
“Deal” said the homeowner, NEVER.
LOL.
Confidential Treatment Order (ct Order)
Source: Edgar (US Regulatory)
June 5, 2018.
Does this come into play near-term or irrelevant?
Monster volume! This beast is still trucking!!!
Analyst at HW WAINWRIGHT moved this to 52 week price of $3 share last week. Forget pumpy dumpy newsletters. The DD is there for the taking.
HC Wainwright set a $3.00 price objective on CorMedix (NYSEAMERICAN:CRMD).
Stocks like CRMD tend not to follow traditional TA during these type of events. Big weeks ahead.
You need to slow down, lol.
Tell us about the pipeline
Easy $1! Boom!
Solid day!!’
Shorts take a run then they are buffoons and they will reap what they sow.
Better not turn off their cell phones—margin calls coming.
Amen, sir. The $3 price target isn’t a joke. The technology works so well they recommend the study ends early.
Everyone think about that. Let that sink in. This is as real a deal as they come.
This is a winner. Enjoy the ride.
Wow, you are now on block! Why I ever even replied to someone like you, I’ll never know.
Hahahaha. Oh I’m getting paid, Richard Cranium.
CDRM.
53,000 @ .254.
Shhhhhh.
It's happening!
CorMedix price target raised to $3 from $2 at H.C. Wainwright. The analyst raised price target for CorMedix to $3 saying the Neutrolin interim readout delivered a "home run."
H.C. Wainwright analyst sees a possibility now for Neutrolin to be filed before the end of this year and to be approved in 2019, versus his original assumption that the drug would not enter the U.S. market prior to 2020.
Further, the news of the clear efficacy signal in the LOCK-IT-100 study could meaningfully accelerate U.S. sales of the product, the analyst adds. He reiterates a Buy rating on CorMedix.
YAWN.
Then why are you here?
CorMedix Inc. (NYSEAMERICAN: CRMD) is having a great start to the trading session in the pre-market hours this morning after the company announced positive clinical data. Of course, the positive data excited investors, sending the stock screaming for the top. Today, we’ll talk about:
The clinical results;
what we’re seeing from CRMD; and
what we’ll be watching for ahead.
CRMD Announces Phase 3 Results
As mentioned above, CorMedix is having an incredibly strong start to the trading session today after providing a clinical update. In a press release issued early this morning, the company announced that the independent Data Safety Monitoring Board (DSMB) has completed its review of the interim analysis of data. The data came from the ongoing Phase 3 Lock-It-1– clinical study assessing Neutrolin®
In the release, CRMD said that because the pre-specified level of statistical significance was reached and efficacy has been demonstrated, the DSMB recommended ending the study early. The company said that no safety concerns were reported by the DSMB based on the interim analysis. As a result, the company plans on submitting the results of the interim analysis to the United States Food and Drug Administration for review.
In a statement, Khoso Baluch, CEO at CRMD, had the following to offer:
We are thrilled to have received the DSMB’s recommendation that efficacy has been demonstrated. Once we have submitted the interim analysis results and DSMB’s recommendation to the FDA, we will begin the dialogue on the appropriate next steps… We have invested a significant amount of the Company’s resources over the last 2 ½ years in this study, and it is gratifying to have achieved this result based on the interim analysis. We believe Neutrolin has great potential to save lives of patients receiving hemodialysis therapy as a treatment for end-stage renal disease and to lower overall healthcare costs due to reducing the risk of catheter-related blood stream infections (CRBSI).
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that the news causes moves. In the case of CRMD, the news proved to be overwhelmingly positive. After all, positive clinical data pushes the company one step closer to regulatory approval of Neutrolin®. So, it comes as no surprise to see that excited investors are sending the stock on a run for the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (7:56), CRMD is trading at $0.42 per share after a gain of $0.15 per share or 51.79% thus far today.
What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on CRMD. In particular, we’re interested in following the story surrounding the company’s continued work to bring Neutrolin® to market following the news of the positive results. Nonetheless, we’ll continue to follow the news closely and bring it to you as it breaks!
Eh, how’s this working out for you? ROFLMAO!!!!
Loving me some CRMD!!
GIDDY F’ING UP!!!
HOME RUN!!!
CorMedix price target raised to $3 from $2 at H.C. Wainwright H.C. Wainwright analyst Raghuram Selvaraju raised his price target for CorMedix to $3 saying the Neutrolin interim readout delivered a "home run." The analyst sees a possibility now for Neutrolin to be filed before the end of this year and to be approved in 2019, versus his original assumption that the drug would not enter the U.S. market prior to 2020. Further, the news of the clear efficacy signal in the LOCK-IT-100 study could meaningfully accelerate ex-U.S. sales of the product, the analyst adds. He reiterates a Buy rating on CorMedix.
Read more at:
https://thefly.com/landingPageNews.php?id=2764589
Today's Research Reports on Stocks to Watch: USANA Health Sciences and CorMedix
ACCESSWIRE
July 26, 2018, 8:10 AM EDT
NEW YORK, NY / ACCESSWIRE / July 26, 2018 / It was a day of gains for both USANA Health Sciences Inc. and CorMedix. USANA reported record results for the second quarter while CorMedix announced the Data Safety Monitoring Board's positive review of the interim analysis of data from the currently ongoing Phase 3 LOCK-IT-100 study for Neutrolin. The company can now submit results to the Food & Drug Administration for review.
I suspect we’re going to hear about NDA submission very soon.
Today was catalyst #1. It’s go time and it’s going to kick ass.
Something tells me we’re going to be hearing from CRMD soon.
I’ll get right on that.
Yay! I can’t wait for your asshat followers to trash the stock. I believe some arrived in advance.
Um, exactly who brokers these after market transactions. LOL.
Good call.
Ok. So MM’s have mysterio bags of millions of shares conjured from thin air. Got it.