If what you say is true - the SPA is a legal agreement and not a contract - then AMRN management has to follow the appeals process and pursue a lawsuit. A poster on ST supposedly has reliable information from a FDA source that they simply "changed their mind" regarding surrogate endpoints vs CVE's regarding Anchor and the SPA. If this is indeed true, the FDA has no legal defense and the Anchor SPA would never make it to litigation (compromise).
The SPA dust has now settled and we're at a level most expected. Short term, we're probably going to hover around $1.30 - $1.40. We could touch the 52 week low before we finally bottom out. If you believe in the fundamentals going forward then now is an excellent entry point.
There are three types of investors in this stock today - those that gambled on the SPA and lost (casino gambles), those with a short term horizon (shorts, option player) and those who believe in the science and are willing to wait this out for the interim analysis in 2016. Currently, about 70% of posters fall in the first two categories with an obsessed with weekly scripts. AMRN management telegraphed their hand this past week. First, they made peace with the FDA with the language of their CC. That would suggest the appeal process has come to an end and they will focus resources on Marine and attempt to bridge the organization to 2016-18. They are also committed to the completion of Reduce It - which was a broadcast message to the FDA and BP. AMRN management is also aware of the event rate and feels positive about tracking to date - hence RI completion.
The most compelling component going forward will be BP. Once the dust has settled and there's closure on the sNDA, valuation will become a little more certain. If scripts significantly accelerate, it wouldn't be surprising to see BP buy a minority stake in this company - say 20% - and bridge funding to 2017-18. This approach has been employed with HGSI and others in the past. In any event, it's not likely AMRN will not see RI completion in 2018. This company will have been acquired IF we have positive results in 2016.
AMRN has discovered that playing hardball with the FDA won't bode well come Reduce It completion in 2017-18 time frame. I've tried to figure out the FDA end game regarding Anchor, the SPA and the whole CV outcomes mess the FDA has created. and have recently developed a theory. After the FDA blessed the SPA, several members of Congress with ownership in PFE realized the end game for statins. Lipitor accounted for roughly $7 bill in sales and essentally a money pump for the company. As of a couple of years ago, PFE was also the 6th most widely held stock of our esteemed leaders in Congress with 60 members holding roughly $6 billion. GE was first, followed by PG, MSFT and CSCO. The recent redefinition of statin use combined combined the modified policy of CVE events was more then a coincidence. It was decided that statins will be pushed at the expense of alternative therapies. This company has significant regulatory and political hurdles to overcome. I think AMRN management has realized this and no longer wants to challenge the more well established pharma industry as well as create waves with an agency getting its cues from the blue bloods with money and connections.
Someone out there needs to contact 60 Minutes for a Scott Pelley story on the FDA. It doesn't have to investigate how Amarin was "wronged" by the FDA but rather profile the benefits of prescription grade EPA in light of recent studies and recommendations by AMA, JAMA and so on. The FDA would obviously be put under the spotlight and forced to indirectly defend their actions in how they've handled this whole AMRN
The FDA has zero PR exposure and feel they do not need to defend their overall decisions - period. There's almost this organizational arrogance and a culture that lacks accountability much like the IRS. I'm still totally mystified by the guidelines that are stated on the FDA website as well as recommendations/views of every major health organization in the United States that recommendations trigs below 150. What are the current medical recommended guidelines if you're non-diabetic and currently not taking statins with trigs 200 let alone if you're diabetic? The FDA has essentially left a void for physicians and patients to treat at their discretion.
I would love to see the whole PDUFA fee process unfold and discussed by 60 Minutes as well as interviews with former BP execs that went to work for the FDA and back to BP. The whole FDA/SPA debacle is sickening and has caused a loss of millions of dollars of AMRN shareholder value. What's even more sickening is loss of potential life for those who are diabetic with elevated trigs. I see OREX finally had their weight loss drug approved in spite of major side effects this past week. Vascepa has zero side effects. The only reason the FDA has allowed these recent weight loss drugs (Q, Contrave and Belqiv) to hit the market is due to the ongoing pressure of Michelle Obama, the obesity crisis and recent pressure by Congress. I think it's about time to have a piece by 60 Minutes put the screws to the FDA and attempt to expose them for what they are - a government run gatekeeper for BP.
FDA stated last year the Anchor SPA and sNDA were viewed as separate events. AMRN has yet to receive a CRL after last year's (October) PDUFA meeting. It will be interesting to see managements next steps with this still on the table.
3) Why did the FDA do what it did?
To try to predict what the FDA might do in response to AMRN appeals and protests, we first need to understand what the FDA's motivation might have been for doing what it has done so far, especially the very unusual step of rescinding the SPA for AMRN's ANCHOR trial. Two types of hypotheses have been widely debated. They center on either FDA distaste for some aspect of AMRN as a company, or on an untoward influence of big pharma with competing drugs on FDA decision-making. I favor a hypothesis that does not contain either of those aspects.
Current medical practice for prevention of cardiovascular disease is in a muddle regarding who might benefit by treatment with statins, the failure of some cholesterol lowering drugs to show cardiovascular benefit and the role of elevated triglycerides in this arena. I cannot possibly review all of the relevant aspects of these controversies here, but it is sufficient to observe that if the FDA had required studies demonstrating cardiovascular benefits before approval of the huge pharmacological armory aimed at lipid metabolism, then much of this uncertainty would have been avoided. The FDA realizes that it has contributed to the confusion, and I believe that its requirement for demonstrated cardiovascular benefit from Vascepa is one step in its attempt to clear up this mess. The stakes are high: Billions of dollars of drug sales are involved in control of lipid metabolism, and the health of many millions of US citizens hangs in the balance.
Therefore, the FDA believes that what it is doing with respect to Vascepa puts it on the side of the angels, even if its actions have involved some minor excesses. A powerful motivation would be required for the FDA to reverse this position.
4) A weak incentive for the FDA to revise its decisions
Pressure on the FDA by Congress is one of the few effective levers available to move that agency to act contrary to its own agenda. However, after all of the Co
2) FDA behavior with respect to Vascepa
The FDA Briefing Document for the Vascepa Advisory Committee Meeting was very revealing. That document is clearly a biased account of the science surrounding Vascepa. It is a manuscript with a mission, a chronicle with a cause. One of the clearer examples of the bias of the briefing document involved the control results from the ANCHOR study. Patients in the control arm experienced a worsening of certain lipid parameters while ingesting mineral oil placebo. The Briefing Document hypothesized that some previously unknown adverse effect of mineral oil placebo was making Vascepa look more effective than it was, and that perhaps the mineral oil interfered with the absorption of statins. It admitted that a search for any corroborating evidence for this hypothesis proved futile. Indeed, mineral oil has been used as a placebo for decades with no evidence of effects on lipid metabolism or drug absorption.
Meanwhile, the following line of reasoning was ignored. Patients enrolled in the ANCHOR clinical trial were allowed to have previously used a number of lipid-altering treatments, including fish oil supplements. A washout period of 4 or 6 weeks was provided in the trial protocol during which the effects of these other treatments could possibly disappear before trial treatment and measurements began. What if that treatment effect was not gone by the time that the placebo treatment period was started? Then any deterioration in lipid parameters during placebo treatment could be attributed to the continued loss of the previous treatment rather than any effect by the placebo.
Indeed, if the authors of the Briefing Document had bothered to look, they would have found scientific studies supporting this conclusion. Look here, here and here. If I could find this information with minimum effort, specialists in cardiovascular medicine should have been aware of it. This lack of a thorough and balanced review of the relevant scientific literatu
SA article released at 9:35 EST
The FDA surprised many observers when it rescinded the Special Protocol Assessment for the phase III ANCHOR trial for Amarin Corporation's fish oil drug Vascepa.
Some investors hope to profit from a long position should the FDA fully or partially reverse this action on appeal.
Consideration of the circumstances around the rescission leads to a prediction about what the FDA will do, with implications for FDA actions in drug approvals going forward.
Recently, Amarin Corporation (NASDAQ:AMRN) has regained some ground after large share price losses associated with FDA actions. The current bull thesis can be found in these two accounts of the company's situation vis-a-vis the FDA in TheStreet and Seeking Alpha. While those articles make some valid points, I see the short-term situation differently from either of them.
Before discussing how this situation is likely to play out, a very brief review of the situation regarding AMRN's drug Vascepa will help those readers not very familiar with this story. The results of the phase III ANCHOR trial showed that Vascepa was effective for lowering triglyceride levels without increasing 'bad cholesterol' levels in patients taking statins and with high levels of triglycerides from 200 to 499 mg/dL. These results met the requirements of the Special Protocol Assessment, and thus approval for marketing of Vascepa for this large patient population seemed as certain as you ever can be with the FDA. Instead, to make a long story short, the FDA surprised almost everyone by rescinding the ANCHOR SPA. The current FDA position is that the surrogate endpoint of triglyceride reduction is now insufficient, and that use of Vascepa for the ANCHOR indication will not be approved until AMRN completes a cardiovascular benefits trial called REDUCE-IT.
Why the LJ anology???????? You don't get the big picture. Just an opportunity to create awareness within medical community and do a little PR. These dog and pony shows also an excellent chance to communicate with analysts. You need to take some marketing 101 courses.
Because I plan to flip it either tomorrow or Thursday at 2.15 -2.20 for a small 300-400 profit. Will pay for weekend beer money.
You may be getting a little ahead of yourself. If the company's get a favorable decision with a new PDUFA date, we could be talking about 10-12. NCE probably isn't going to happen but two for three would put buyout chatter back on the table.
Weakness across the market and a less than robust jobs report. Instead of lamenting about TRX above 9,400,and PPS down at 10:00 EST, accept the markets and PPS for what there are - irrational - and load up at $1.89. If you believe in the company fundamentals, then what's the problem???????????????
AMGN is apparently filing for their PCSK9 inhibitor which is an injectable with the potential of reducing cholesterol and LDL by up to 50%. I have a sense this could be damaging to Anchor and its combo with the current combo class of drugs. My question is this: does the PCSK9 platform now being developed also have the ability to lower other lipid biomarkers such as APO, hs-CRP and the inflammatory markers that would also affect Reduce It?
You have to wonder what AZN's intent is here. When they bought Omthera, I was under the impression they intended to use Epanova as a combo drug to extended the life cycle of Crestor. Since the acquisition, a lot has come out supporting pure EPA. While I thought GSK would have been a potential suitor for AMRN contingent on Anchor/Reduce It, you wonder if AZN is kicking the tires. Trials to date tend not to support the EPA/DHA class of drugs.
There is a subtle strategy that GSK is using in trying to off-load Lovaza. They are fully aware of the changing perception of EPA within the FDA and recognize that harvesting Lovaza is a prudent move. Roughly 70% of Lovaza scripts over the last couple of years have been off label (Anchor Market). They will probably not make a move until Reduce It is close to being complete but will assume ultimate control of Anchor and utilize their vast CV field force to replace lost Lovaza sales.