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

[Tug life]

Amarin: A Strong Chance Of A Positive Vote For Vascepa - Amarin Corporation plc (NASDAQ:AMRN) | Seeking Alpha

The FDA briefing documents for the November 14 AdCom meeting are a strong positive for Amarin (AMRN). The conclusion was that "the benefit-risk assessment favors the use of Vascepa for CVD risk reduction". Mineral oil was seen as only having a 3% impact on the CVD risk in the worst-case scenario, leaving around 22% RRR attributable to Vascepa.

The only negative appears to be a potential cautionary note about the potential for increased risk of atrial fibrillation/flutter, but that appears most relevant for the 9% of the study population with a prior history of that.

 

[KING WILL]

Listening now. Just went over what the FDA doesnt like about Vascepa.

Amarin just has to answer the questions properly.

He did say the FDA believes the risks doesn't outweigh the benefits.


Seems like the biggest issue is, such a broad label from only 1 study, not multiple studies.

 

[Skooby]

Its still not too late breh.

I'm about to get a few shares.

 

[KING WILL]

Going well so far.

There were a few hiccups tho.

They are letting professionals talk now, while they are for, or against it. but a few speakers ago, due said this:


You must understand why you are here. This will be the most important ADCOM over the next decade, or longer. Dont make the mistake you made 5 years ago. Every day you dont approve VASCEPA for Expanded use, lives are lost

 

[jaguar paw]

I'm about to get a few shares.

Amarin Corp. PLC AMRN+2.63% followed through on Wednesday, up 55 cents to $21.49 after popping 23% on Tuesday. An FDA advisory committee is scheduled to meet today to help decide the fate of the company’s fish-derived cardiovascular drug. While trading has been halted this morning in advance of the meeting, the chart points to a test of the July high in the $23.50-$24.00 zone next.

Just FYI

 

[KING WILL]

I lost the feed about 30 mins ago. From reading on ST and YMB it seems like things has taken a turn for the worst.

Some of the ADCOM people are still asking about Min. Oil even tho they have answered the Q again and again.

Its weird this, cuz I thought this was for the FDA. But the FDA had its own people give a presentation too and it was largely in support of Vascepa.

 

[KING WILL]

16-0 Baby!!!!!

 

[Tug life]

16-0 Baby!!!!!

Congrats all Amarin bulls what will it do when it's unsalted?

Cormedix up next

 

[ahomeplateslugger]

yooo ACST just got a huge pop which means good news for AMRN is coming right??

 

[Tug life]

Cormedix got the holy trinity priority review, LPAD, and rolling submission. Up 12% after hours. Conference call starts now. I'll be back later with a full analysis

Yahoo is now part of Verizon Media

FINANCE

CorMedix Inc. Reports Third Quarter 2019 Financial Results and Provides Business Update
November 14, 2019, 4:05 PM EST
Conference Call Scheduled for Today at 4:30 p.m. Eastern Time

BERKELEY HEIGHTS, N.J., Nov. 14, 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 financial results for the third quarter and nine months ended September 30, 2019 and provided an update on recent business developments.

Recent Corporate Highlights:


Positive responses received from the FDA regarding the Company’s pre-New Drug Application, or pre-NDA, meeting questions relating to the preparation of the NDA. The FDA agreed that Neutrolin is eligible for priority review, setting a review period goal of 6 months rather than the standard review period of 10 months. The FDA also agreed that the Neutrolin NDA submission is eligible for rolling review and that the Company’s proposed submission plan is reasonable. The FDA further agreed that it is appropriate to submit a request for approval of Neutrolin under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD Pathway) at the time of the NDA submission.

 

[KING WILL]

Nov 14 (Reuters) - A panel of experts to the U.S. FDA on Thursday recommended allowing Amarin Corp Plc's fish-oil derived drug to be used as add-on therapy for reducing the chance of heart attacks and strokes in high-risk patients with cardiovascular disease.

The panel voted 16-0 in favor of expanding approval, potentially opening up a multi-billion dollar opportunity for the company which has only one drug, Vascepa, in the market.

Vascepa, a highly purified omega-3 fatty acid derived from fish oil, won U.S. approval in 2012 to lower high levels of triglycerides — a type of blood fat that can increase the risk of heart disease.

The Food and Drug Administration is not mandated to follow the recommendation of the panel, but generally does.


Yahoo is now part of Verizon Media

 

[KING WILL]

good shyt @Tug life

 

[jaguar paw]

good shyt @Tug life

Word. Thank you both for this thread and the contributions.

 

[ahomeplateslugger]

no charts available for AMRN right now. what do y'all think this will open at?

gonna drop a good amount of my money on amrn, acst, crmd and mtnb tomorrow

this could be a really big win for me if all goes well. i'm getting a little fuzzy thinking about it

 

[Tug life]

Huge day for us congratulations to all of us who hold positions in any of these stocks.

Amarin knocked it out of the park with a unanimous decision, and with the stock being halted all day I can't even imagine what'll happen when this opens and everybody piles on not to mention the short squeeze that'll happen. Reading post today it seemed some people thought the Adcom meeting would fail but that surely didn't happen.

Cormedix earnings report was really straightforward they have enough cash until 2021 enough to submit NDA and initial launch of Neutrolin. As I shared in my last post they have received very good news from the FDA.

They can get priority review which shortens the drug review time from 10 months to 6 months

Rolling submission which means that the can submit parts of the NDA as they are finished. They don't need to wait until they finish the whole thing. One must nite that a NDA is about 70-100,000 pages and are delivered in trucks.

LPAD (limited pathways approval for antifungal drugs) which gives Neutrolin expedited approval for drugs shown to have a great need in deadly viruses.

To get just one of these is a tough job but we got all 3. I'm not sure how the market will react because CRMD doesn't seem to spike that much on good news maybe they waiting for appoval or buyout but I will continue to accumulate until next year. Approval is expected next year and whether or not we get bought out, this product will be the standard of care in the United States and will generate huge revenue.

Our next catalyst is NDA submission and then approval. Maybe we find a partnership in between I'm not sure but the data is pure.

Acasti follows Amarin right now. The bigger Amarin is The better for Acasti as well because it creates a larger market. I expect Acasti to follow Amarin up until it's time for Acasti's data which will be next month.

Acasti, Amarin and Cormedix is the holy trinity. We will make good money on these 3