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

[KING WILL]

AMRN[/a]) is one of Wall Street’s biggest standouts, with shares skyrocketing 566% in just the last year. Its fish-oil derivative drug Vascepa is already clinically proven to lower very high triglycerides without raising bad cholesterol. What’s more, recent trials revealed it could also cut cardiovascular risks by 25% in patients with abnormally high triglyceride levels. The FDA will either approve or reject this potentially very lucrative label expansion on September 28, and approval should send shares soaring.' data-reactid="11">Its fish-oil derivative drug Vascepa is already clinically proven to lower very high triglycerides without raising bad cholesterol. What’s more, recent trials revealed it could also cut cardiovascular risks by 25% in patients with abnormally high triglyceride levels. The FDA will either approve or reject this potentially very lucrative label expansion on September 28, and approval should send shares soaring.

An approval would make Vascepa the first therapy, as an adjunct to diet, proven to reduce cardiovascular events when used to treat patients with persistent elevated triglyceride levels and other cardiovascular risk factors. It is this large, unmet medical need for potentially tens of millions of patients which Vascepa has been targeting for many years.

Ahead of this key date, Cantor Fitzgerald analyst Louise Chen has just released a very bullish report on Amarin. She made the call following the company's recent equity raise. “The proceeds should help accelerate the growth of Vascepa, and we think the peak sales potential of this drug could be $5B-$10B” writes Chen. FactSet forecasts $2.1B of sales by 2024.



Indeed Amarin currently shows a ‘Strong Buy’ Street consensus with all six analysts covering the stock bullish. Meanwhile the average analyst price target of $33 suggests shares can surge over 80% from current levels.


Yahoo is now part of Oath

 

[funkee]

will monitor amrn and try to get to 1000 shares in the next 1-2 weeks maybe closer to 1200.

 

[KING WILL]

I think this was well planned, as one of the analyst said a week, or 2 ago, Amarin CEO has played this game perfectly.


I think JT (The CEO) knew we had a few positive catalyst coming up:

1. This ICER report that came out today.
2. An ER that would beat estimates.
3. Evap Study results.
4. FDA sNDA approval.

All of this between today and the end of Sept.

Now, he also knew that, in order to benefit (asap) from an expanded label, he would also need to increase his salesforce, more funds of expanded advertisement, an increase in supply, plus whatever else I could not think of. All of this takes more $$$, which for us equaled the dilution we seen a few days ago which led to a huge drop in SP.

So, instead of waiting for these catalysts to happen (and seeing the stock price go up) then raising funds (only to see the see price drop again). He raise guidance 1st (causing the SP to shoot up), then raised funds (causing the SP to drop like he knew it would. This benefited us in two ways I can think of:

1. We would pretty much end up at the SP we started at.
2. We would be able to raise more money while offering less shares overall.

With dilution out of the way, we should see the SP rise organically thru the catalysts listed above.

Plus this got Goldman and a few other Investment Banks/Firms in our corner. Of the 22 Million shares offered, I think Goldman got a lil over 8 Million of them.

 

[Tug life]

This price action seems to suggest something is up. The last couple of times we had runs like this with no news, some news came shortly after. Either this is a run up into earnings which is 2 weeks away, or somebody knows something. We'll see soon enough

 

[KING WILL]

I argued previously that $350 million was a too conservative number and while the increased guidance is very bullish, it still seems conservative considering the year-to-date growth trends. The low end which suggests very modest sequential net sales growth compared to the second quarter sales of $97-101 million. Based on the current prescription growth trends, I believe Amarin is on track to generate full-year net sales at least at the high end of the company’s guidance range, and possibly, significantly above it, especially if Vascepa’s label is expanded in late September.

https://seekingalpha.com/article/4273355-amarins-updated-guidance-may-still-prove-conservative



But to piggy back on those numbers again.

I think $380M-$420M is to low of an estimate too. Assuming 20% increase each Q puts us at about $435M.

Sales jumped by about 50% in the 4th Q last year when the REDUCE-IT results were announced.

Earnings for 2nd Q at $101M.

 

[Tug life]

Looking to accumulate my last bit of shares in the $9 range. It looks like when we break that $10 resistance it'll run a little bit and then finding it's support in the $10 range. Definitely want to be locked and loaded by the time earnings come around.

 

[Tug life]

New article lists cormedix as one of the 7 A rated stocks under $10

Yahoo is now part of Oath
BOOM!!!!

CorMedix (CRMD)
CorMedix Inc (NASDAQ:CRMD) is a commercial-stage pharmaceutical company that focuses on its taurolidine technology to build a non-antibiotic, antimicrobial that can prevent bloodborne infections and inflammation in patients that are on IVs and catheters.

It will be a contender with the long-time go-to, heparin.

Earlier this month, the stock got a boost when the company announced that the Food and Drug Administration determined that it had passed its Phase III trial and doesn’t need to expand its study further. That means CRMD is much closer to getting Neutrolin to market.

It currently has a $219 million market cap and the stock has been doing well for a while. It’s up 46% YTD and a whopping 214% in the past 12 months. CRMD has a good chance to be bought out or get a big licensing deal with a large pharmaceutical company.

 

[Tug life]

AMRN got killed after hours I expect it to sell off tomorrow as well. Their approval date has been pushed back from September to December. This may provide a buying opportunity. I think it's a little bit of a overreaction. @KING WILL what's your take on this?

 

[ORDER_66]

People should definitely start buying this shyt...Again...:usureboutthatbreh: I'm trying to load up on PTN before that blasts off...

 

[KING WILL]

AMRN got killed after hours I expect it to sell off tomorrow as well. Their approval date has been pushed back from September to December. This may provide a buying opportunity. I think it's a little bit of a overreaction. @KING WILL what's your take on this?

I think this is in part due to the Evaporate Study which is ending in Sept. I think instead of doing this twice, they are extending it to include it in its decision/label expansion. Huge overreaction, because the science is still the same.

Some investors been wanting ADCOM since the sNDA was 1st filed, but being this late in the game everyone thought an adcom was no longer in the cards.

Man, I woke up rd 6 and seen the SP and was fukking blowed! Im just now getting unbusy, so I got a lot of reading to do weigh some pros n cons.

Def gonna add some shares tomorrow, just don't know how much yet.

 

[KING WILL]

missed the cc, but heres a breakdown:


CONFERENCE CALL:

THE GOOD: John Thero repeatedly pointed out that Reduce It was created a decade ago and carried out with the FDA approval and guidance, including the selection of mineral oil as a placebo. "ADCOM is not necessarily a bad thing... It's customary really for a breakthrough drug like this to have an ADCOM. We're going into it optimistically and with confidence in our data." ... "We are planning for success. We expect that this will lead to approval in December." ... "We now have more time to recruit and train people. I am confident that we will use all of this added time productively. ... Good things don't come easy." Asked about mineral oil, he said noted that literature has indicated mineral oil is inert and it has been used in many studies for a century. "I will remind people the selection of mineral oil was made with the assistance of FDA. We looked for a placebo that matched the color, consistency and taste of Vascepa." He said mineral oil and Vascepa in the study acted "pretty much spot on" as expected. "I have no reason to believe the FDA is not looking to help improve patient care . ... This is a study they wanted." He also said an ADCOM would allow them to talk about the results of the study broadly and to "do education."

THE BAD: Thero sounded upset. Somewhat crushed, actually. He said the FDA asked Amarin not to announced right away that an ADCOM would occur in November. "We value our relationship with the FDA and trust that they appreciate we had little practical choice but to inform our shareholders."

THE UGLY: Share price drops $4.

 

[ORDER_66]

missed the cc, but heres a breakdown:


CONFERENCE CALL:

THE GOOD: John Thero repeatedly pointed out that Reduce It was created a decade ago and carried out with the FDA approval and guidance, including the selection of mineral oil as a placebo. "ADCOM is not necessarily a bad thing... It's customary really for a breakthrough drug like this to have an ADCOM. We're going into it optimistically and with confidence in our data." ... "We are planning for success. We expect that this will lead to approval in December." ... "We now have more time to recruit and train people. I am confident that we will use all of this added time productively. ... Good things don't come easy." Asked about mineral oil, he said noted that literature has indicated mineral oil is inert and it has been used in many studies for a century. "I will remind people the selection of mineral oil was made with the assistance of FDA. We looked for a placebo that matched the color, consistency and taste of Vascepa." He said mineral oil and Vascepa in the study acted "pretty much spot on" as expected. "I have no reason to believe the FDA is not looking to help improve patient care . ... This is a study they wanted." He also said an ADCOM would allow them to talk about the results of the study broadly and to "do education."

THE BAD: Thero sounded upset. Somewhat crushed, actually. He said the FDA asked Amarin not to announced right away that an ADCOM would occur in November. "We value our relationship with the FDA and trust that they appreciate we had little practical choice but to inform our shareholders."

THE UGLY: Share price drops $4.

Share price $4????

 

[KING WILL]

Dropped $4.

*** Not dropped to $4.

 

[ORDER_66]

Dropped $4.

*** Not dropped to $4.

that's still a huge loss considering it was just at $10 a few days ago...

 

[Tug life]

missed the cc, but heres a breakdown:


CONFERENCE CALL:
THE BAD: Thero sounded upset. Somewhat crushed, actually. He said the FDA asked Amarin not to announced right away that an ADCOM would occur in November. "We value our relationship with the FDA and trust that they appreciate we had little practical choice but to inform our shareholders."

THE UGLY: Share price drops $4.

I'm not sure I'm reading this right are you saying the FDA asked them not to announce it and they did it anyway? one thing you don't want to do is piss off the FDA.

And why would the drop all the way dwn to $4 from like $17 this week?