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Who is we? You should speak for yourself first. I don't want a trial with a placebo that does harm to patients muddying the waters. They had to bash Mineral oil because they know their placebo is far worse.
No, the placebo is corn oil which will have a negative impact on the placebo arm. The Epanova trial is trash.
EPANOVA placebo is not olive oil, it is corn oil, an omega 6.
They do not get briefing documents.
Thank you Sam.
So what approved indication do they think is not covered by orange book patents? What indication are they trying to carve out?
So what indication are Hikma/Reddy running trials for? When will the trials be done and approved?
It could be that the stock continues to run back up and is trading at 21 or 22 by the time the briefing documents come out and no possibility that they can get it below 19 if the documents have some negatives. We just don't know, but a small drop in price will not matter in the long run.
The SEC requirements are required for every stock. How to read financial disclosures is pretty basic. Partial summary judgements and script numbers are pretty specific. Other investors and analyst can help you with that. If you can read and understand what is put out there to the SEC you can understand the public information about a company. That knowledge should come first.
The one in Florida is Catalent Pharma Solutions in St Petersburg, Florida. They put the EPA into the capsules. It is a thriving operation. The parking lot is always full. Back when they first started manufacturing Vascepa, not so much.
Just my opinion but you should probably should not invest in individual stocks if you can't understand standard SEC forms. take some time out to read and understand the instructions for them and you will not regret it.
This is not appear to be a legit bloomberg article. This Jared Holz guy has not worked at Jefferies since 2010 according to his linkedin profile.
I always thought he was short. Either way, it does seem to be a good time for shorts to move on.
Thanks for your analysis. It lines up with AMRN website update and should put everyone at ease.
We are in agreement on what you wrote. Big money being spent on options today. I am sure it is coordinated.
Did you read the full report? It was a pile of crap and yes, I have decades of experience reading these reports and a lifetime in healthcare financial services to back it up.
This is a primarily a form letter. There are many similar letters being posted.
I posted the complete report that came out with the $17 price target. It was clearly not convincing. They needed more to back up their low target and this is it.
In other words, the initial analysis was crap and everyone knew it. They now have had to come up with something to back into their crap.
Here was the initial analysis. https://drive.google.com/file/d/1-mpx4cbZaS7i7w1HoGCS8quac5RcwJBr/view
The GS report itself has been posted previously if that is what you are trying to clean up.
Has anyone tallied the posted responses to the AdCom docket so far? How many in favor, how many against. If this has been posted recently, I apologize as I have been out of the country.
"But completely overlooked by the conspiracy theorists." Your whole post sounds like something said by a conspiracy theorist.
The label does not indicate the ceiling. It will just tell us how much will be on-label and off label. Just wait until the commercial showing the benefits and the very little risk. The physicians have already been learning about it and the sales are up 80-90% from a year ago. Now that ICER report is final Amarin can continue discussions with insurance companies. Once Amarin can promote Reduce-it results sales will increase rapidly. Everything is starting to align.
Take the lowest dose statin and take Co-Q-10 along with Vascepa. Give that a try for a period of time and I think you will be pleased.
I don't know the process in great detail but I would think once the EMA rules on the accelerated approval we should pretty quickly see the actual EMA filing be made.
New Reduce-it patents being in place before filing are going to be a great bonus for longevity of the patents in Europe.
Part of the process before actually filing is requesting accelerated approval. Amarin has requested accelerated approval and the EMA should rule on it this week.
That is not what I meant.
These same people who bought it at $18 shorted it not he way down and are buying it back right now. Don't feel sorry for them or think that they somehow got screwed.
This was a huge offering and it had a huge impact price per share. In order to bring the market cap back in line there was going to be a big drop in share price to bring the market cap back oil line.
In addition,If you read the documents with the offering, Amarin expected a AdCom and they got one. Anyone who trades biotech knew that Amarin would take a dump when the Advisory Committee was announced.
Two drops in share price and look, amazingly, our market cap sits at 5.6B. It will rise from here.
Their clients.
Your post is total BS. When firms buy secondaries in a company like this, they do not buy them for the short term. They buy them for the long term. Do you really think whoever bought them thinks about what the price is right now, before approval. They knew it was going to dip, there is no doubt about that. They knew they were going to try and shake out retail.
I think so, we should be getting ICER Final report and EMA accepterated review question before the end of the week.
That's great. You have to wonder how much NAFLD and NASH and other liver issues would really be out there if everyone was on Vascepa that should be.
As an example, I had several ALT and ASH numbers that were out of normal range before I started Vascepa. Inflammation was becoming an issue. Since taking Vascepa those tests have been in the normal range for me. If not for Vascepa, I could have progressed to more serious issues.
In the supplemental analysis it shows -
• Non-alcoholic fatty liver disease (NAFLD) analyses using NAFLD Fibrosis Score (NFS), assessing – ITT Population:
o Effect on primary and key secondary composite endpoints by baseline NFS category, and,
o Treatment effect on change from baseline in NFS at 1 and 5 years
Not surprised at all. The only person concerned about patents at this point is MRC.
Medicaid is not going to pay for Vascepa until they have too. That is where the Generic lovaza scripts are still coming from.
Think about why you are worse. Are you really worse or do you have more money at stake this time around. if you have more at stake or a larger percentage of your wealth at stake it may seem that your paranoia is higher.
It's pretty simple, insurance coverage. Medicare and Medicaid will be the majority of the scripts and they need the indication before they will provide reasonable cover.
Thanks for trying.
There may be a few cardiologists that feel that way but Dr. Bhatt would tell you that Jelis is the other trial. Follow his twitter feed since reduce-it was first announced. He has no doubt and that is the way he and others have continued to present it.