The Official CORMEDIX (CRMD)thread (run up to FDA approval has begun )

[KING WILL]

I think hes saying the price dropped BY $4, not that it will drop DOWN to $4.

Yea, you def dont wanna make enemies of the FDA, but sued the fda back in the day and won over freedom of speech in regards to how they could market Vascepa. I think this was in 2012. From this, the REDUCE-IT study was formed.

 

[KING WILL]

Recovering well right now.

That post market $4 dip is a $2.67 dip right now.

Huge buying opportunity and ppl are taking advantage.

7.2 M Volume less than 10 mins.

 

[KING WILL]

From Ihub post:
Sam - I think your non-conspiracy theory makes the most sense. Priority Review was granted because all boxes were checked. The process was smooth until after the late cycle meeting, a time which JT said previously was when label negotiations started. There is some "point person" in the FDA responsible for the Vascepa application, and when it was clear that a very broad label would need to be considered (e.g., no minimum TGs, all individuals at CV risk taking statins), that individual felt it was necessary to call an Ad Com so that they had scientific backing for a broad label. There is no way to tell whether the FDA or the company initiated consideration of a broad label. This seems to be the only rational (no tinfoil hat required) series of events that would reconcile PR fast track with a VERY late ad com. If there were any major issues with the sNDA application, a CRL would have been sent earlier than this. JT's recent comments about the drug potentially being used by 1/3 to 1/2 the population is entirely consistent with this scenario. I know many here have 2013 ad com PTSD, but it is entirely possible that the adcom could end up being a good thing that justifies a very broad label (with the only cost being an extra 3 month wait). They would not go to the trouble and cost of an adcom without also addressing any other lingering issues (MO, arrhythmias), but the fact is that R-It results are stellar and the drug is safe based on multiple years being on the market without problems. Bhatt will no doubt be heavily involved in preparing for the adcom, and as a scientist, I find all of his responses addressing potential R-It design flaws very convincing, and I think an adcom panel would also. The fact that the adcom is not until mid-November might also lead to EVAPORATE results being available (at least privatately to the FDA) which if successful could totally resolve the questions on MO confounds and MOA of V. I have had too many times in my life when seemingly bad news turned out to be good news in retrospect, so I am disinclined to jump off the cliff at this point. None of us can predict what is going to happen, so why assume the glass is half empty?

 

[Starski]

Good luck to all long on amrn but I think it’s goibg to fill the gap

 

[SEX!!]

Good luck to all long on amrn but I think it’s goibg to fill the gap

what does this mean

 

[Tug life]

CRMD earnings report tomorrow after hours at 4:30. Looking for to an update on our status with the FDA and about any potential partnerships.

 

[KING WILL]

His reasoning: "It's difficult to say why the FDA has chosen to convene an adcom this late in the game." Regardless, "our research and checks ... underlie our confidence that Vascepa's dataset will stand up to the scrutiny of a panel." But even more than that:

Under one possible scenario, Archila mused, it's possible the FDA might offer Amarin the option of labeling Vascepa for use "for cardiovascular risk reduction regardless of triglyceride levels" -- in other words, permitting the drug to be used by patients no matter how low, or how high, their triglycerides might be. No restrictions at all!

Such a labeling (if it's in fact on the table) would obviously be good news for Amarin. As Archila explains, it "would increase the commercial opportunity for the drug," meaning more sales and more profits for Amarin.

So as a pure question of risk and reward, Archila now believes the odds favor investing in Amarin.


Yahoo is now part of Oath


This would be HUGE considering we should be nearing half a billion in sales by EOY while only being approved to treat TG levels above 500. If label exp. moves beyond TG levels, we might reach sales well over a Bill next year.

 

[KING WILL]

I seen you guys trending on stocktwits. I guess results are so good, no phase 3 will be needed.

Good shyt. Congrats 2 yall.

 

[GunRanger]

Up in after hours trading. Need this FDA shyt already

 

[Tug life]

I've been in Cormedix since September last year and I have to say that was the best earnings call we've had. In a nutshell the Lock it 100 study is done, no need for a second trail. We have enough cash to get us through the next year so they will not have to dilute shares. We beat earnings expectations by a great margin and they are ramping up to bring neutrolin to market. All foreseeable risk have been removed. The CEO acknowledged that neutrolin is far superior to the current standard of care and there is no competition out there for us. It's almost a given that we'll get approved everything is just a formality right now.

The CEO also stated that they are willing to partner with a big pharma company. That news will send us to about $30 at least, not to mention how much a buyout would be. I see us breaking $10 in the next couple weeks on the way to $12-$15 soon. I should also note that FDA approval wont come until 2020, this whole time should have been used as an accumulation period while getting shares for cheap we may never see the $6 or $7 range again. Now is the time to set it and forget it. We will get major boost to the share price this year with major catalyst but we will definitely have our big payout by the time 2020 elections roll around, unless we get bought out before that

 

[KING WILL]

AMRN up 5% PM.

Leerink initiated an outperform ranking and an $26 PT.

 

[Lord-Yosh]

I've been in Cormedix since September last year and I have to say that was the best earnings call we've had. In a nutshell the Lock it 100 study is done, no need for a second trail. We have enough cash to get us through the next year so they will not have to dilute shares. We beat earnings expectations by a great margin and they are ramping up to bring neutrolin to market. All foreseeable risk have been removed. The CEO acknowledged that neutrolin is far superior to the current standard of care and there is no competition out there for us. It's almost a given that we'll get approved everything is just a formality right now.

The CEO also stated that they are willing to partner with a big pharma company. That news will send us to about $30 at least, not to mention how much a buyout would be. I see us breaking $10 in the next couple weeks on the way to $12-$15 soon. I should also note that FDA approval wont come until 2020, this whole time should have been used as an accumulation period while getting shares for cheap we may never see the $6 or $7 range again. Now is the time to set it and forget it. We will get major boost to the share price this year with major catalyst but we will definitely have our big payout by the time 2020 elections roll around, unless we get bought out before that

 

[Tug life]

Just an update on the current status of where we are with CRMD. We are completely finished with clinical trials for Neutrolin, this means the drug has been shown to be effective and we can start with filing our new drug application (NDA). Everything from this point on is just paper work and meetings. In the last conference call they stated that they expect to be approved for NDA by the second half of 2020. I expect around this time next year the NDA would have been approved.

That timeline may be upsetting to some investors who where expecting for approval this year. I personally only had plans to hold until January 2020 looks more like 4th quarter 2020 for me which has been said to be recession territory. The 1 thing that may come this year that'll boost the share price will be a partnership with a big pharmaceutical company. As the CEO said in the CC yesterday

Let me be clear, our goal is to maximize shareholders’ value. Because hemodialysis is a very concentrated payer provider market, we are continuing to prepare CorMedix to launch Neutrolin in the hemodialysis segment, while at the same time being open to potential partnerships. We are now beginning the process to recruit into CorMedix, the commercial market access and medical affairs leadership for the U.S. market. We also acknowledge particularly in the area of oncology, TPN, and critical care that these in a very broad and therefore would be more appropriate that a larger, more strategic care who already is in this space be best able to maximize shareholders’ value.

I think we can see a partnership before approval and hopefully that'll be this year. While retail investors have been selling off. Institutions have been buying shares for the last couple of months. Remember this was one of the reasons they did the reverse split, so that certain tutes who couldn't buy under $5. Goldman Sachs even started a position.

CRMD Institutional Ownership, Buyers - CorMedix Inc.

CRMD has been making all of the correct moves to become successful, all of which have been documented in this thread. And one thing I learned investing is to follow the insiders and big institutions. If the price continues to drop I'll just buy more and lower my average, at this point we are just waiting and even though it may take a while, we are almost certainly getting approved. We also can't forget that this is not just any regular drug, it will be so big because once approved it will be the standard of care with no competition.

Even with current targets by analyst if correct, we can double our money at the very least which I think is pretty conservative.

my mindstate at this part of the process is set it and forget it.

 

[Lord-Yosh]

Just an update on the current status of where we are with CRMD. We are completely finished with clinical trials for Neutrolin, this means the drug has been shown to be effective and we can start with filing our new drug application (NDA). Everything from this point on is just paper work and meetings. In the last conference call they stated that they expect to be approved for NDA by the second half of 2020. I expect around this time next year the NDA would have been approved.

That timeline may be upsetting to some investors who where expecting for approval this year. I personally only had plans to hold until January 2020 looks more like 4th quarter 2020 for me which has been said to be recession territory. The 1 thing that may come this year that'll boost the share price will be a partnership with a big pharmaceutical company. As the CEO said in the CC yesterday


I think we can see a partnership before approval and hopefully that'll be this year. While retail investors have been selling off. Institutions have been buying shares for the last couple of months. Remember this was one of the reasons they did the reverse split, so that certain tutes who couldn't buy under $5. Goldman Sachs even started a position.

CRMD Institutional Ownership, Buyers - CorMedix Inc.

CRMD has been making all of the correct moves to become successful, all of which have been documented in this thread. And one thing I learned investing is to follow the insiders and big institutions. If the price continues to drop I'll just buy more and lower my average, at this point we are just waiting and even though it may take a while, we are almost certainly getting approved. We also can't forget that this is not just any regular drug, it will be so big because once approved it will be the standard of care with no competition.

Even with current targets by analyst if correct, we can double our money at the very least which I think is pretty conservative.

my mindstate at this part of the process is set it and forget it.

I hope you're right cause this shyt has been killing me since Monday.

 

[Tug life]

I hope you're right cause this shyt has been killing me since Monday.

Short term price action shouldn't matter if you're holding for a big gain. In one of my accounts my average is $8.08 My other one is $7.65 I'll look to add anything under that. Whats your price average?