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david22hughes

david22hughes
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  • Amarin's Anchor Gamble Sends Stock Up 20% On 'No News' News [View article]
    I read crap on these investment sites all the time about how big pharma have no interest in fish oil and Vascepa. That is pure nonsence. If it were the case then GSK would not have bought Lovaza and Astra Zeneca would not have bought Epanova. Vascepa is the creme de la creme of fish oil and Pfizer or whoever WILL get their hands on it.

    The fact is that there is zero reason for the FDA not to approve the ANCHOR indication and they know it. The phase 3 trial proved it lowers trigs without raising LDL while having a safety profile comparible to a placebo. The drug met all primary and secondary endpoints and should therefore be approved albeit with a restricted label about claims of CV benefit.
    Dec 22 07:34 AM | 3 Likes Like |Link to Comment
  • Amarin's Anchor Gamble Sends Stock Up 20% On 'No News' News [View article]
    It goes beyond that. JZ was the main stumbling block to Pfizer or GSK grtting their hands on Amarin and their asset worth billons of $'s. Think about that - billions of $'s; annually; in the US alone. Big pharma are working closely with the FDA to get this drug just the way they want it, make no mistake about it. Anyone who says big pharma have no interest in a multi billion dollar drug needs their head examined.

    I am certain JZ was told it was in his best interest to leave the company or else the kangaroo courts would put him behind bars. I am not exagerating. He finally got the message and left. Now the doors are wide open for big pharma to get their hands on Amarin and they will work with the FDA to get the precise label they want. The ANCHOR indication WILL now be mysteriously approved but there will be a warning label about unsupported claims of CV benefit. This allows the FDA to cover their ass until results of REDUCE-IT are known. Big pharma will happily continue to fund that trial as it will cost them a mere pittance.

    A deal will be done within the next 3 months. Expect Amarin's share price to rocket from here as the smart money begins pouring back in. $2 is a steal. If Lovaza was worth $1.7 billion, Vascepa is easily worth $2 billion. If you factor in the extensive patent portfolio, the cheap API supply which has been locked up, and the potential to tag this on to a statin, one could argue that Amarin are worth closer to $4 billion with the expanded ANCHOR label. A buyout of $2 billion would give a share price of around $11. $4 billion is obviously double that and closer to the rumour buyout price of $20 that was being bandied about post ANCHOR phase 3 data. JZ wanted to hold out for $30, $40, $100 because he is greedy. He aint around anymore.

    Big pharma WILL get this drug. $2 a share is the best Christmas gift anyone could hope for.
    Dec 21 12:38 AM | 3 Likes Like |Link to Comment
  • Amarin: Summarizing The Variables Involved In The Upcoming PDUFA [View article]
    Declan Doogan was the head of R&D at Pfizer before he joined Amarin and designed the clinical trials for AMR101 (Vascepa).

    Lets see what happens to Amarin over the next 3 months. Something tells me that with the announcement of JZ's 'retirement' on Monday that pretty soon we will be reading about a big pharma buyout of Amarin. This drug has the potential to be a multi billion $ drug in the US alone. There arent too many of those knokcing around currently. Big Pharma arent interested?! What are you smoking dude?
    Dec 17 10:06 PM | 3 Likes Like |Link to Comment
  • Amarin's CEO Quits On Shareholders And Vascepa [View article]
    Does the timing of this strike anyone as being very odd? The week of the FDA ANCHOR decision? Really? There has to be more to this going on behind closed doors than the public are privy to.

    I say Amarin get label approval for ANCHOR but with restrictions about claims of CV benefit pending results of the REDUCE-IT trial. They will be finally bought out by either Pfizer or GSK within the next 3 months who will fund the completion of the trial and market the ANCHOR indication while they are waiting. JZ was the main stumbling block to a buyout and now he's gone.

    Anyone any idea about what this company is actually worth? When JZ left Reliant and GSK got their hands on Lovaza they paid $1.7 billion in cash. Amarin have to be worth at least $2 billion with Vascepa being best in class, the huge patent portfolio, API supply locked up, REDUCE-IT 75% already enrolled etc
    Dec 16 11:18 PM | 2 Likes Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]
    "Anchor criteria were met as you said, but they were wrong."

    Who set the criteria? The FDA. It's their mistake, no-one elses. Why should Amarin and its shareholders suffer because of incompetency within the FDA? Amarin did EVERYTHING required of them with a substantial amount of cash and time invested.
    Nov 27 11:39 PM | 2 Likes Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]
    Dont be surprised if the ANCHOR indication is approved in December with the same 'WARNING AND PRECAUTIONS' label pertaining to the fact that "The effect of Vascepa on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established", just like it has been for Lupin's Antara fenofibrate drug.
    Nov 27 11:36 PM | Likes Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]
    So what changed between then and now? The ACCORD-Lipid, AIM-HIGH, and the HPS2-THRIVE studies have no bearing whatsoever here. The ONLY study of ANY relevance to this particular drug (Vascepa) and its mechanism of action is the JELIS study and even that has its shortcomings.

    The acceptance of the sNDA for ANCHOR was based on Vascepa meeting its predefined safety and efficacy endpoints and the REDUCE-IT outcomes study being 'substantially underway'. ALL CRITERIA WERE MET. It would be criminal to reject the ANCHOR indication at this stage.

    I completely agree that until REDUCE-IT is completed, if ever (it is insane to deny the company label expansion and deprive them of potential revenue which would help its continued funding and completion), claims of CV benefit cannot be included on the label. What the drug does is lower triglycerides without any side effects in the 200-499mgs/dL range. The FDA should approve the drug for the ANCHOR indication because its is safe and does what it is supposed to do. Whether or not it reduces serious CVE's has yet to be determined. There is 'inferred evidence' but nothing conclusive. REDUCE-IT will go a long way to clearing the whole thing up. For now, both MARINE and ANCHOR should be approved but with label restrictions about claims of CV benefit. That is fair all round.
    Nov 27 05:17 AM | Likes Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]
    Anyone care to enlighten me as to why the ANCHOR trial was conducted in the first place if lowering trigs in the 200-499mgs/dL range is deemed to be of no CV benefit?

    How can the goalposts be moved after the agreed upon safety and efficacy endpoints were met?

    Who reimburses Amarin for the millions of $'s and time they invested in performing the trial if the ANCHOR indication is not approved?

    I
    Nov 27 02:00 AM | Likes Like |Link to Comment
  • Amarin CEO Makes Significant Withdrawals From Shareholder Value Account [View article]
    They do have quite a chunk of cash and the management reckon it will last them until they are profitable but they will be cutting it tight. All depends on how quickly they can ramp up sales in 2014. Without a partner and with only a small sales force like they currently have, i dont see it happening any time soon.
    Nov 14 01:18 AM | 2 Likes Like |Link to Comment
  • Amarin CEO Makes Significant Withdrawals From Shareholder Value Account [View article]
    In summary - JZ is a greedy CEO. What's new?

    Going by the tone of the conference call it sounds to me as if Amarin are hell bent on going this thing alone. What could and should have been a huge uptick in share price with a positive ADCOM vote and ANCHOR approval in December, now looks like a very speculative long term investment. This share price is going nowhere fast without ANCHOR approval or buyout. JZ aint interested in selling below $30 apparently so I cant for the life of me see him selling this asset for $7/share or whatever.

    If they do continue to go this alone I fully expect Amarin to team up with a marketing partner like Arena have done with EISAI. JZ has mentioned many times before that a partnership is the least desirable of the options open to Amarin but with a rejection of ANCHOR he will be left with no other better choice. A partnership with an expanded sales force would go a long way to help erode Lovaza's market share and the increased revenue could be used to continue the funding of the REDUCE-IT trial. Makes no sense whatsoever to terminate the REDUCE-IT study with it having such a relatively high chance of success what with its safety profile and the positive results of the 1.8g JELIS study - the only outcomes study of ANY relevance here (REDUCE-IT uses 4g of EPA by the way). There is huge potential shareholder value in that trial and to scrap it at around 75% enrollment would be insane. It is also insane however for the FDA to expect Amarin to continue it without approving the ANCHOR indication. We live in an insane world.
    Nov 13 08:43 PM | 1 Like Like |Link to Comment
  • Can Amarin Salvage Its Earnings Call? [View article]
    Gibberish. Yet again you fail to answer the questions asked. Why did the FDA allow the ANCHOR trial to be conducted if they considered lowering trigs in the 200-499mgs/DL range to be of no clinical benefit? Why did they accept the ANCHOR sNDA?

    I'll keep asking until soneone can give me a good answer.
    Nov 6 10:01 AM | 2 Likes Like |Link to Comment
  • Can Amarin Salvage Its Earnings Call? [View article]
    Those crackpots over at Harvard appear to think trigs over 200mgs/DL are a danger.

    "When it comes to heart health, the largest and most common form of fat in food and the bloodstream—triglyceri... taken a back seat to “bad” LDL cholesterol and “good” HDL cholesterol in the public’s awareness. That’s changing as researchers get a grip on how triglycerides influence the risk of heart disease, reports the February 2008 issue of the Harvard Heart Letter.

    Triglycerides are in the danger zone when they slide above 200 milligrams per deciliter of blood. To keep triglycerides in check, lifestyle changes are usually the best place to start, notes the Harvard Heart Letter. These eight steps can lead to impressive reductions in triglycerides:

    Beware of bad fats. Cut back on saturated fat (found in red meat and full-fat dairy foods) and trans fat (in some fried and commercially prepared foods).
    Go for good carbs. Eat whole grains and cut back on sugary drinks and foods.
    Check your alcohol. Moderate drinking is good for the heart, unless you are a "responder" in whom alcohol dramatically boosts triglycerides. To determine if you’re a responder, avoid alcohol for three weeks and have your triglycerides tested.
    Go fish. Omega-3 fats in some fish lower triglycerides. Have fish twice a week.
    Aim for a healthy weight. If you are overweight, aim to lose at least 5% to 10% of your weight to lower triglycerides.
    Get moving. Exercise lowers triglycerides and boosts HDL.
    Stop smoking. Smoking isn’t good for triglyceride levels (or anything else).
    Get help from a medication. Niacin, fibrates, fish oil, and cholesterol-lowering statins have all been shown to lower triglycerides. "

    http://hvrd.me/1b1XsHy
    Nov 5 10:18 AM | 2 Likes Like |Link to Comment
  • Can Amarin Salvage Its Earnings Call? [View article]
    Why did the FDA allow the ANCHOR trial to be conducted if they considered lowering trigs in the 200-499mgs/DL range to be of no clinical benefit? Why did they accept the ANCHOR sNDA?
    Nov 5 09:57 AM | 3 Likes Like |Link to Comment
  • Can Amarin Salvage Its Earnings Call? [View article]
    Horseshit. None of you FDA supporters can answer me this simple question. I will ask it again. Why did the FDA allow the ANCHOR trial to be run in the first place if lowering trigs in the 200-499mgs/DL range is of no clinical benefit? Why did the FDA then accept the sNDA?
    Nov 5 09:11 AM | 5 Likes Like |Link to Comment
  • Can Amarin Salvage Its Earnings Call? [View article]
    So why did the FDA allow Amarin to run the ANCHOR trial in the first place? Why did they set the terms of the SPA and say REDUCE-IT needs to be 50% enrolled before the sNDA was accepted? Why waste everyones time and money if its just a worthless fish oil?
    Nov 5 09:01 AM | 2 Likes Like |Link to Comment
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