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Most Cardiologists will say that they rely on evidence based medicine. What that means, is that now, because of Reduce-it, there is evidence that Vascepa does an amazing job of reducing heart attack, stroke etc. They know that they will prescribe Vascepa no matter what the MOA.
User reviews- It looks like short interest has made a concerted effort to impact user reviews for Vascepa on webmd(.)com website and drugs(.)com website. Please post some truthful reviews to these websites to offset ridiculousness. Thanks.
When did he say it?
Commercial Insurance companies are notoriously short sighted. They only care about current year costs. Part of their thinking is that the patient could move to a different plan next year. This is one time where because of standard of care they will have to bite the bullet.
Amazing that there is no public information regarding EPA blood levels being involved in either the generic drug case or the Advisory committee but suddenly you think it is key to both.
He was upset because the FDA waited so long to announce the AdCom, delaying the priority review. JT thought he had waited long enough in the process to start hiring. His advisors told him that an AdCom was unlikely at that point in the process. For a priority review the AdCom should have already occurred. If you recall, we all were pissed.
I am not a fan of buying call options as that puts external pressure on the stock price. IMO, buy the stock. It is not an all or nothing proposition and you actually own something. It is also not dependent on time.
The past and current are two different things. Amarin has done what the FDA asked. The results far exceeded expectations. Amarin wins in the end.
There are some crazy ass conspiracy folks here and this post is proof. There is overwhelming clinical evidence of Vascepa benefits. The Medical community is totally on board with Vascepa. The FDA will expand the label and Health Canada will approve this drug before the end of the year.
I sold some at 22. I wouldn't dream of selling it at 15.
There is nothing there specific to AMRN circumstance. It is just to sow doubt.
There are articles out there telling us when to buy as well.
It is confusing. I do not see where Amarin referenced "correspondence" in a press release in August.
On what grounds ? On the grounds that it is not natural. It does not occur in nature. It has to be altered to get to that composition.
If you are going to do it you should include Hikma and/or Dr. Reddy ...
The way I see it, if Omega VIA EPA is really 85% EPA, it is not a dietary supplement and shouldn't be allowed on the US market.
FDA is not interfering in the generic patent case. BB's imagination just seems to be in overdrive.
It looks to me like there was precedent that because Reduce-Its as filed during ongoing citation connected to the NDA that Amarin was required to give the generics information related to the sNDA. I don't think it is a part of a broader scheme related to the FDA.
IFOS has tested it because there is one one sheet of paper on their website. How often is it tested? Does the formula violate Amarin's patents? Is it illegal to sell in the Untied States and breaks other US laws?
Amarin seems to have been responsible for much of the delay in this back and forth but I don't blame them. They wanted to produce as little as possible as late in the process as possible.
Nice password for the zip file.
It takes a few days for the docket information to show up.
This is a crazy discussion. People take fish oil pills every day that are the same size and make you burp fish. Why would those same people not take Vascepa which doesn't give you fish burps and is actually proven to reduce the risk of heart attack and stroke. It's a ridiculous issue.
It doesn't have to be morning, it can be at lunch.
We have had 7 weeks of Biotech small and midcap outflows. Oversold. This should be the bottom.
Wow, no it isn't, and I don't believe they have said he was in iCU.
Because stents go in through an artery and the procedure is more of an imaging procedure than like an open heart the bill will not be that bad. < 20k would be my guess including a couple of days of room and board.
DNDN is the Biotech example of how terrible the market treats small biotech companies. People have been showing up on message boards with DNDN horror stories just to scare retail. Yes DNDN was bad but many times there are no or very few similarities.
Next numbers published will be up because of the last secondary.
It is interesting there is no October Investor slide presentation posted yet. I hope it is a good one.
There are instructions for statins "To maximize the effects of statins with a short half-life, statins such as fluvastatin, lovastatin, and simvastatin should be dosed at bedtime allowing the greatest drug concentration to be present during peak endogenous cholesterol synthesis."
Cholesterol production in the liver is highest after midnight and lowest during the morning and early afternoon, so statins are most effective when taken just before bedtime.
AMRN dropped when the overall market dropped.
Suntrust note snip-it. Anyone have the full note or can get it?
From twitter -
Tom Silver
@TomSilver39
Suntrust:" $AMRN FDA panel on 11/14.Expert call on omega-3s: believes the panel will go AMRN’s way, although the outcome with respect to the Vascepa label is difficult to predict. Panel could have broad implications for the space, including for smaller players $ACST and $MTNB..."
Why do you say pumped? That would imply that they updated guidance and they shouldn't have. Talk was that they had sandbagged guidance before this increase. It was time.
That shouldn't impact the current market cap. JT very recently has said if the sales reach 10B, he will be able to supply the EPA.
This is not Health Canada's website. This is an somewhat independent review committee looking at reimbursement similar to ICER.
CADTH believes that credible, objective evidence should inform every important health care decision. When you want to know what the evidence says, ask CADTH.
CADTH is an independent, not-for-profit organization responsible for providing health care decision-makers with objective evidence to help make informed decisions about the optimal use of health technologies, including:
drugs
diagnostic tests
medical, dental, and surgical devices and procedures.
In addition to evidence, we also provide advice, recommendations, and tools.
This came from the CEO from HLS Therapeutics, the Canadian partner. They have regular quarterly conference calls and have had at least one investor conference.
Last I heard from HLS, expecting approval in November, Canadian launch in February.
Amarin has guided to a 4th Quarter filing. 4th Quarter starts tomorrow.
"Maybe a European filing to cheer us all up and pass the time? "
Wow, thank you. This really helps put the total market and Vascepa potential into perspective.
Edited to add: The physicians prescribing these really could be a market that Vascepa Sales reps should target once insurnance coverage is improved.