Amarin Corporation plc Message Board
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SRPT has had a nice run. The absense of news and lack of AA filing weighs heavily. The FDA meeting
is or has taken place. The Agency doesn't respond until 30 days following the meeting. I love the name
long term, but wothout AA , the stock trades down to @ 25. If you're tax efficient (Capital Gain), then sit tight.
If you're not and just trading, I would take money off the table now. You'll most likely buy it back cheaper.Sentiment: Buy
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This is a market of stocks, and
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Would you kindly post your short thesis so that those who are on the opposite side of the trade have a sense of your thinking.
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I would be surprised if aa were given. We have an exciting company but my guess is
as long as gsk's trial is not halted for safety issues, it remains a viable competitor
and i can't recall agency having ever done that before. One thing most folks have missed is the history of antisense, and the acute toxicity of oligonucliotides. It's been 15 years to get a second product approval with an rnai drug. Gsk's drug is an oligonucliotide, and ours isn't. I only hope you're correct and i'm not. - Reply to
Breakthrough Therapy is the gold standard. Chris was afraid talking might jinx it.
by shimp41 •Mar 7, 2013 9:52 AMI am hopeful fda is considering this a breakthrough therapy. That said, the small patient cohort, and gsk's competing drug may mitigate against it. Bottom line srpt is a long term hold and having a 50% position prior to agencys decision, is risk management. I would always err on the side of safety. It just makes sense. If the aa is not granted, i would then load the boat to full position size at around 25. The recent run up is in anticipation of aa. One man's opinion ! Being tax efficient by paying long term capital gains as opposed to ordinary income is good portfolio manbagement.
Sentiment: Strong Buy
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Managements execution is key. They have been their .done that, and learned from both their
successes as well as mustakes. They may not be popular with the folks who are short, but let their
mothers worry about that. The Anchor patent alowed today is more significant than meets the eye.
It further supports their recent NCE filing for the Anchor indication. It may circumvent the FDA standard of of awarding the NCE with approval of Vsacepa for mixed dyslipidemia. I would assume that Management, hating uncertainty, would prefer to get this overhang removed either Yea or Nay. -
the most salient point of AMRN's recent launch is the Management Team. I have been pleasently
surprised with their presence in Most Peer reviewed Journals in Cardiology, as well as Web MD,
and the Journal of the AMA. The old mantra in Medicine is "See one, Do one, Teach one" -
You're mastubatory habits have seriously altered your thinking.. Check the palms of your hand
and I wouldn't be surpised if you are starting to grow hair. - Reply to
NCE decision on or before March 15 could send this over 20+ (re-test may 2011 highs)
by sec.informer •Mar 6, 2013 11:46 AMIt is highly unlikely that the NCE wiil be issued prior to year end. Once the sNDA for mixed dyslipidemia is
approved, The FDA legal Division actually grants the NDA , NCE's are given with drug approvals. Since Lovaza is not approved for that indication, ie, there is no prior art , FDA Legal can issue it and avoid the risk of a law suit from GSK (they have been quoted as threatening to sue ) It's just legal cover.Sentiment: Strong Buy
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Not so ! the analysts at leerink, jpmorgan, citibank, jefferies, all confimed that there were multiple discussions, and 2 lowball
offers. I give him credit for his course of action. This is not hgsi
or dndn, with expensive drugs with high costs, modest benefits and
outragious pricing. Vasceepa produced data and p values somewhat
better than lipitor. Do some research, unless you're pimping for the
missguided shorts. The data is the data.Sentiment: Strong Buy
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The delayed launch was strategically sound. Joe, as well as all the longs
were anticipating a buy out. Had it happened, it would have saved the co.
gia and having to hire a sales force. The good news is a successful launch
will create share holder value, which after all is the job of a good ceo.
the nce approval is a function of fda legal team which no one can contoll.Sentiment: Strong Buy
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JL: I have more or less supported your posts as they are factual and well thought out. If you could scroll
back to "Presumption of Favorability" posted earlier today, as I'd appreciate you take. I believe it is both
factual and fundamentally important. -
I remind all the posters on this site of what the precedence is for receiving an NCE. The
only situations that are comparable to AMRN's, are the Insulins, Heparins, and Low Molecular Weight
Heparins. There are at least 14 NCE's that FDA has awarded to Co's with competing drugs
in the above mentioned classes. They all received NCE's inspite of Prior Art being listed in the Orange Book.
The rational sited as Precedent by FDA is " the preumption of favorability" Check FDA website for information.
I believe that an NCE in AMRN's situation is predicated on Anchor approval for Mixed Dyslipedemia. NCE's are usually awarded with an approval of a drug. Check Novo Nordisk, Momenta, and Lilly. The run rate
for Vascepa is running ahead of Lovaza's initial launch. The drug did $1.5B at peak !!! With a vastly superior
product I can't envision AMRN doing less at peak sales for only the Marine indication. The game changer
is approval for the Anchor indication. I have been informed by the largest Patent Law Firm located in Northen Ca. that since Lovaza is not listed in the OB for Mixed Dyslipidemia, (no prior art) the presumption of favorabity rational would give the FDA Legal Team cover should GSK threaten litigation. Yes I am in the business and long AMRNSentiment: Strong Buy
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I remind all the posters on this site of what the precedence is for receiving an NCE. The
only situations that are comparable to AMRN's, are the Insulins, Heparins, and Low Molecular Weight
Heparins. There are at least 14 NCE's that FDA has awarded to Co's with competing drugs
in the above mentioned classes. They all received NCE's inspite of Prior Art being listed in the Orange Book.
The rational sited as Precedent by FDA is " the preumption of favorability" Check FDA website for information.
I believe that an NCE in AMRN's situation is predicated on Anchor approval for Mixed Dyslipedemia. NCE's are usually awarded with an approval of a drug. Check Novo Nordisk, Momenta, and Lilly. The run rate
for Vascepa is running ahead of Lovaza's initial launch. The drug did $1.5B at peak !!! With a vastly superior
product I can't envision AMRN doing less at peak sales for only the Marine indication. The game changer
is approval for the Anchor indication. I have been informed by the largest Patent Law Firm located in Northen Ca. that since Lovaza is not listed in the OB for Mixed Dyslipidemia, (no prior art) the presumption of favorabity rational would give the FDA Legal Team cover should GSK threaten litigation. Yes I am in the business and long AMRN -
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IT WOULD BE NICE IF THE CEO BOTHERED TO FILE FOR AA, HE HAS NOT YET.
by moneyandstocks •Feb 26, 2013 2:36 PMPrudence dictates that he waits for fda minutes with agency . Believe it
or not, fda doesn't appreciate aggressive moves for pub by sponsering
companies. - Reply to
WHEN ONE SRUG HAS SIDE EFFECTS, THEY INVESTIGATE DRUGS LIKE IT.
by carlhill975 •Feb 27, 2013 2:00 PMThe two drugs have different mechanisms of action. Targets, and pathways.
your conclusion is inaccurate,Sentiment: Strong Buy
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The important takeway of GSK's failure with their DMD drug is that FDA would be more incentivized to
give Accelerated approval to SRPT. When you speculate on Partnership/Buy Out it is just that, speculation.
Recent data on assumed BO'S is dicey at best, and more often than not incorrect.Sentiment: Strong Buy
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Not so fast nay sayers. Have you seen the rebates Phama and Biotech have to pay quarterly to fund
"Obamination' ? If Romney were Pres , do you think liberal Hollywood would have had His wife
announce best picture. This is not the site for these postings, but I had to add a pertinent comment.Sentiment: Strong Buy