Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
This is like waiting for a pot to boil. Perhaps if we just look away for a few minutes it will heat up.
Anyone here familiar with the "Semmelweis Effect"? It describes a reflex-like tendency to reject new evidence or new knowledge because it contradicts established norms, beliefs or paradigms.
The phrase refers to a Hungarian/German physician in the mid-1800s who tried to convince physicians to wash their hands before delivering babies. That advice was roundly rejected, despite a nasty post-natal mortality rate, due to infection. Years later Pasteur was able to clinically prove "germ theory" and hand-washing became a more acceptable practice.
If Amarin has more leeway in educating doctors about EPA, perhaps we have a hope here, because clearly there is a Semmelweis Effect in terms of realizing the anti-inflammatory properties of EPA.
By the way, Semmelweis died broke, in an insane asylum. Hope that doesn't happen to AMRN investors!
For all longs (like myself) who were looking for a miracle today, hang in there. It still looks very promising for us. No bragging, no hard feelings, please. We're all in this together - with some notable exceptions.
JL, My expectations are based on the various reliable information (what there is of it) posted on this board, and various opinions expressed (of which there is quite a lot). Just as HD says, IMO. It's like putting odds on a game, that's all.
My expectations for October 30 are as follows (HDG style):
Joint Request for additional time, due to ongoing negotiations: 40%
AMRN Request for Permanent Injunction, due to negotiation failure: 30%
Agreement on basic rules for dissemination of truthful/non-misleading data: 20%
Agreement on expanded labeling (a la ANCHOR), etc.: 10%
Full FDA reversal / reinstatement of SPA: 0%
Let's not get too excited here. We're still in the "small ball" innings, although I won't rule out an extra base hit. That said, AMRN's legal team seems to be doing a good job tiring out the DOJ/FDA pitching arms.
OK, I'm in with:
May (24) / 33% / Feb (2)
Why I expect good news related to scripts and financing matters:
1) Partnerships. Now with 1A injunction in place, and AMRN working with FDA on a meaningful settlement (in terms of promoting V off-label, etc.), I expect one of the big benefits would be a significant improvement in chances of additional partnership deals. This improves both financing and script revenues.
2) Off-label promotions. Some here believe FDA is always in a retaliatory / adversarial relationship with AMRN and "don't care" to change their stance. But I believe court decisions have a way of making regulatory agencies care, and care very much. FDA is 0-fr-2 on significant regulatory issues here. If you think 1A and NCE decisions are minor, I encourage you to re-think your perspective on what kinds of leverage it gives AMRN in promoting V.
All it probably takes for the PPS to experience a significant rise at this point would be a meaningful labeling settlement or another partnership deal, etc. Or any of a dozen other "minor" developments.
Even something mundane, such as the Jeffries conference, may provide significant illumination at this point.
My advice: Buy while you can. Especially if you need to cover a short position.
Loving cmm3's posts and the discussions related to them. I've posted a couple of times about AMRN 's "small ball" legal strategy, and would like to point out, in support of cmm's arguments, why a larger settlement is not unlikely. FDA has lost 2 bad cases in a row, and now clearly understands that its assumptions about due regulatory process are not defensible. FDA not only bungled the whole SPA process but probably cannot defend its position on any grounds, including the questionable appeals super-structure it put in place. The real threat of justice on a larger issue is clearly in sight. DOJ attorneys have likely pleaded privately to settle this matter in the best possible way. I do not expect small results here. If FDA continues its folly, there are huge consequences. AMRN has no reason not to ask for the moon.
Couple of weekend thoughts:
1) not sure why we are worried about improvements in U.S. CV events over the past, since a lot of effort has been made to recruit non-U.S. Participants.
2) I seriously doubt AMRN-FDA settlement includes " unwritten" understanding about FDA playing nice. Attorneys don't go for that, especially given past FDA actions and the fact that it's AMRN in driver's seat. (Ask your divorce attorney!). It will ALL be written down.
3) I notice we tend to argue more when important events are dead ahead. Nerves are getting to us! Relax, and be nice here folks! Or it will be so much harder to be friends later in Vegas. And finally,
4) you know you have a problem when you take this much time to post on a weekend.
I think FDA needs the 60 days, not AMRN. FDA needs that much time to run a settlement scheme up every flagpole and get every seal of approval it needs to avoid utter embarrassment of having this go back to court for a 1st Amendment ruling.
FDA has to be concerned that a 1st Amendment ruling puts a lot of their drug oversight activities at major risk. Then they'll wish they'd have come up with a new off-label policy a long time ago when they had the chance.
Here's a thought: Whatever FDA hashes out with Amarin will not be limited to the 2nd District. We've been concentrating on the jurisdictional limits of the recent ruling, but if FDA comes to some agreement with AMRN about truthful, non-misleading conduct, it would have to be considered a universal agreement. Still, I bet FDA can't do it, and it will be in the hands of the judge again.
In the upcoming meeting, AMRN and FDA have been tasked with hashing out the very same issues FDA has been asked to resolve previously: what will FDA accept as truthful, non-misleading information that can be shared with the medical community for potential off-label use?
FDA was dragging its feet on this issue forever, and most recently was touting some "public input" meeting sometime in the future. But now, due to the 1st Amendment case, they cannot rely on bureaucratic machinations to drag their feet on this issue any more.
What AMRN will NOT be interested in negotiating is a process for vetting their communications, one by one. Instead, it will be negotiating with FDA to get an honest terms of what the FDA is comfortable accepting in terms of promotional speech. If FDA cannot adequately answer this question, it will be left to adjudication. And currently, the judge is highly unlikely to give the FDA the kind of leeway they've enjoyed in the past.
There's no way AMRN will be running every new promotional communication by the FDA first - that just solidifies the agencies ability to stall, deny, threaten and intimidate.
My guess is the FDA will not be able to come up with acceptable terms, and it will be back in the judge's lap.
No appeals expected here. FDA has far too much to lose. The more it avoids judicial scrutiny the longer it can play the regulatory games that have propped up its bureaucratic regime. Must avoid additional congressional scrutiny, especially now that election season is approaching.
As for the limits of the ruling, let's be rational here: AMRN shouldn't be required to file complaints in all federal districts in order to roll out truthful non-misleading information anywhere it pleases. Do you really think the FDA wants to go through similar litigation in other districts? (That said, AMRN may opt to take a more conservative approach for a few months.)
AMRN now 2 for 2 in meaningful litigation, playing small ball. Bigger hits to come. If I were Woodcock I'd get those meetings on revising promotional statute language going right away. At this point it's their only line of defense. Problem is, they are likely loathe to take action on anything touching upon speech issues at this point, and any public deliberations would only give their enemies more ammunition in the courts.
So, play ball, AMRN! The momentum is all yours!
After reviewing the FDA letters posted by HD (thanks as always!) the agency's rationale appears quite reasonable on the surface. However, JL is right to question the "behavioral" aspects of the FDA's management of the SPA process. I wonder how the AMRN SPA compares to the basis used in the other 9 cancellations. Or for that matter to the 190 or so other SPAs that have not been rescinded. Has the FDA used the same yardstick for all, or are they singling AMRN out unfairly?
No judge is going to argue science in the courtroom but they are experts in analyzing regulatory procedures.
The assumed lack of timely notice by FDA is one thing, but other troubling aspects include arbitrary definition of effectiveness, management of AdCom, and other potentially questionable actions by FDA.
NCE ruling has already exposed a certain level of capriciousness on FDA's part. I don't think it would take the world's greatest attorneys to make some strong points along similar lines in the SPA case. Perhaps AMRN is awaiting rulings and final results of NCE and 1st Amendment cases before making a decision about further litigation.
Another buyout concept that has occurred to me is this:
Given: a buy-out offer can come before R-IT or after R-IT. It is, as always, a matter of valuation.
If you wait until after R-IT, and the study is successful, you spend 10-XX billion dollars (if R-IT is successful, that is). And you have to compete with other large companies, so there's a bidding war. Good luck with that.
If you buy AMRN before R-IT results, you spend much, much less. If R-IT is successful, you are a great leader. If R-IT is not successful, you still have a drug that is getting a larger and larger share of hyper-trig market, as well as a drug that may have significant applications in other areas (such as diabetes and DES). But at this point the downside potential is getting smaller and smaller.
If you want to buy AMRN now, you'll need to structure the deal to to allow for R-IT success, so it's an upfront price plus some way of sharing future profits. This is not unheard of.
If you buy it later, then you may be dealing with a company that's already solvent, and has multiple partnering agreements in place. This could which may make a purchase more difficult - and ultimately cut into your potential profits.
So I think a good case can be made for a buyout offer at this time. Whether or not it's acceptable is another matter. But it would have to be a striking offer.
Making this more viable is the possibility that 1st Amendment case may increase potential valuation of AMRN. So if we get a win on 1st Amendment case, you may be seeing more than just a normal bump. Say - 25-50%. Now how does that early buyout offer look?
That's my optimistic choice of scenarios. Not pumping - just long, long, long here.
Back to legal strategy here. I have posted about the "small ball" approach to the legal strategy: tightly focused complaints that chip away at the FDA's regulatory abuses. Now perhaps the value of that approach is becoming clear. In defending its positions, FDA's legal credibility begins to break down at every point. Base hits for now, pretty soon some extra base hits, and then, hopefully, home runs to seal the victory.
The legal strategy is "small ball" as I said before. Chip away, bit by bit, at the FDA in the courtroom until they grant the Company what is due them.
With each successive lawsuit (first NCE, then 1st Amendment) more information about the decision making at FDA is exposed to the public.
Legal team must be hoping for a statement about SPA debacle to pounce on later, if needed. JW may have already provided this, in her statement.
Also, judge's ruling may include additional leverage in future actions / negotiations, etc. As I recall, AMRN not only won the NCE judgment, but it included judicial opinion that the FDA was not conducting its affairs correctly. This could also be the case in the 1st Amendment trial...judge could issue a warning to FDA about its conduct.
He might even go further than that. If he smells something really bad, he may suggest some additional scrutiny of the FDA. It's like a trial for one matter, during which another, potentially more serious matter gets exposed. And this all falls under the "small ball" legal game plan.
But for now, it's all about 1st Amendment issues, and I expect the judge to stick very, very closely to those issues, due to the underlying magnitude of his decision.
Last comment is simply a shout out to the fine contributions by HDG, JL, BB and Zu...hoping to eventually book a visit to Las Vegas to meet all!
The Woodcock Response may go down as one of the most self-damning pieces of history-lecture twaddle to ever be issued by the FDA. I don't know if, after AMRN's response, the judge will feel obligated to issue an injunction, but I am pretty sure the Anchor indication is a slam dunk at this point. The FDA and their legal experts might want to strongly consider an offer to Amarin before oral arguments do more damage to their regulatory powers.
The study on cholesterol crystalline domain levels
the timing of the recent study couldn't be better. It's like AMRN is building its case both inside and outside the courtroom, getting out of the FDA chokehold. Classic reversal in wrestling terms. At this point it appears (IMO) that if the FDA isn't talking major compromises this is going to the courtroom. and we all know the GDA's reluctance to settle.
Seems to me this 1st Amendment suit takes over where SPA appeals left off. Rather than make a final appeal to an adversarial party under their terms, Amarin is taking a different tack: Complain to the courts that its first amendment free speech rights are being abused, and provide the court with the history of the SPA debacle as part of their complaint.
I have not read the FDA "regulatory" letter response, so I'm not sure, but if the FDA has responded directly to the SPA sections of the claim, then it may well be a matter of whether the judge wishes to include language about the SPA in their ruling.
It's like Amarin is exposing a loose piece of thread and getting the courts to unravel an entire piece of regulatory cloth.
My questions: Are we even sure that legal counsel outside the FDA even reviewed their response letter before they posted it? And if so, did they even care to question the quality of the response - or did they just let it go because they couldn't care less?
I believe the Amarin strategy to use lawsuits to chip away at the FDA has been more successful than many of us assumed. We thought the NCE suit was negligible - turns out it's not. Many now believe the very narrow scope of the 1st Amendment suit is minor, but it's really a cleverly designed, poison-tipped spear. Regardless of the innocent seeming, narrowly focused complaint, the judge must establish his or her rationale for their ruling. Regardless of the narrow scope of Amaron's complaint, the judge's rationale could easily extend to all sorts of other "speech" issues for pharma. The FDA has seriously erred in asking the Justice department to defend their ridiculous actions, and I assume the deeper their attorneys get involved in this, the more urgently they will advise the FDA to find a more defensible solution. Really, it's been a brilliant strategy so far.
HD, You deserve a break here. From what I can tell, most every other poster believes the FDA illegally rescinded the SPA. You don't. The fact is, the legality of the FDA's action will always be debatable until it goes to a court of law. Only until that time will a judge rule on whether the rationale used by the FDA confirms to law or not. You make FDA's argument a very logical one, however it may be possible for a judge to consider their rationale faulty. Perhaps Congress did not direct the FDA properly, and the FDA is free to interpret SPA options in a bit of a vacuum. Most of us believe that if it came to the courtroom, AMRN would have more than one argument against FDA's rationale/interpretation of statute. However - unless AMRN cares to file suit, we will never know if the FDA's actions were legal or not. So while I may disagree wholeheartedly with you, as others here do, I cannot say you are wrong. It's lawful until proven otherwise in court.
Wow, the poor justice attorneys who had to deal with this one! The court (and AMRN) was promised some sort of "regulatory" item that would potentially narrow the scope of the complaint. Instead we get a posturing statement with no new regulatory information. The judge must surely see through this - and surely must the DOJ. Something tells me the FDA is still being told they need to come up with something better - and fast.
BB, clinical trials posting is dated 4/15/15. So it looks new.
ZU: re Brain atrophy in cognitively impaired elderly
It looks like the board overlooked this post of yours, hopefully posters with medical backgrounds will chime in.
This looks very significant to me. Can you provide a link?
Looks to me like management is playing small ball for now:
Get the base hits (provide funding, grow sales incrementally, make partnerships, protect patents, educate doctors, win NCE if possible), and eventually advance the runners into scoring position.
The FDA pitchers may be tiring. It would be nice to see the (new?) GM and his pitching coach take a walk to the mound to discuss a change.
If AMRN gets enough momentum, then it can swing for the fences (SPA/1st Amendment issues, etc.).
It's looks like a sound game plan to me.
Can you tell its baseball season???
Agreements vs. contracts. Are we splitting hairs?
I am not an attorney, but the unilateral cancellation of the SPA by the FDA seems completely counter to the basic legal constructs of both contracts AND agreements.
I think a court would say the government has an extra burden of proof to use the "effectiveness" excuse for cancelling the SPA, and even if they successfully cancel it, AMRN may be due some consideration/remuneration for the tens of millions of dollars and years of effort involved in holding up their part of the agreement.
HD, I know you keep saying that this is within the FDA's rights, as the law currently stands, and I completely agree with you. But let's remember there are plenty of laws and regulations passed by Congress that get tested in a courtroom and are thrown out.
I know AMRN is publicly committed to finishing REDUCE-IT, and keeping their balance sheet together in the interim. But in the meantime, if the FDA isn't considering some sort of compromise on allowing expanded sales of Vascepa, or finding some other way to soften the blow it has landed on AMRN, I could see some real federal issues cropping up for the FDA.
Personally, I think it's only the expense and time involved that's keeping AMRN from taking this to court. But circumstances can change in that regard.
It seems only natural to assume that if Vascepa's methods of action are anti-inflammatory, then it will have positive effects in more than lipid management issues. Reduced T's are likely a real marker, but perhaps not in the sense originally envisioned when the SPA was signed.
Regardless of FDA's repeated blunders - intentional or unintentional - we are seeing more and more evidence to support the use of Vascepa for a range of conditions, in addition to the CV arena.
As long as AMRN continues to make regulatory and fiscal progress, I have every confidence that we are on the cusp of great success not just as investors, but as potential patients. (Disclosure: I also have a less-than-satisfactory lipid profile.)
I have always felt that the AdCom debacle was intentionally orchestrated to delay AMRN's success, under the guise of protecting patients from ineffective drugs. In addition, I have always suspected that the potential rewards of EPA were so great that strong hands wanted weaker ones out of the pool, and they used whatever influence they had to convince the FDA that Vascepa did not deserve special consideration, including the SPA.
I would not be surprised to see much higher levels of institutional ownership in the very near future. And I expect some nice uptick in prescriptions soon, too. (Even my GP is starting to sound interested.)
Thanks again to frequent posters who have attempted to bring real knowledge to the board. Some of them may have strong personalities at times, but it comes with the territory!
Thanks, HD. ON #2 - didn't Woodcock weigh in on OND panel? I thought she was asked to assist in the deliberations.
I had no idea there were two more potential rounds. Sounds like bureaucracy at its worst.
Since we're re-visiting SPA issues, here's some questions that have been nagging me lately:
Most of us on this board feel the FDA intentionally terminated the SPA using a willful misinterpretation of their congressional directive. Citing concerns that reduced T's would not have an effect on outcomes seems very specious to me. I think a judge would find that the whole justification for the SPA is to allow drugs to come to market earlier - as long as they were meeting agreed-upon preliminary targets. Why else would there even be an SPA?
Next question: Although AMRN has publicly stated they are not pursuing a final appeal, does it necessarily mean they have not exhausted the appeal process? I think a case can be made that if the penultimate appeal involved the same party involved in a final appeal - it's a redundant appeals process. Why would an appeals process involve appealing twice to the same party? Perhaps AMRN's counsel holds the same opinion, privately.
Third and final SPA-related question: we are also assuming NCE decision has little weight on ultimate success of the company, and that the NCE and SPA are completely unrelated matters. However, if during the NCE suit discovery and testimony process, additional light is shed on FDA's regulatory excesses and interpretive malfunctions, is it not possible that a favorable ruling would give AMRN additional leverage in reversing the SPA damage, as well?
Two final notes: I really don't think the FDA is negotiating much of anything with AMRN. I think they've drawn the line in the sand, and are stuck with defending it. Hopefully NCE lawsuit results will alter that stance!
I've been reading all posts diligently, and welcome JL's return, as well as HD, BB, Zu, BioChica, Hitchie, Epi, Dancing, and other good posters. Hopefully my questions spur some interesting discussion...
Thanks, ZUMANTU! I have been hoping for something like this, as I have unsuccessfully been lobbying my cardiologist to prescribe V off label for me. I have really horrendous history with statins, and was hoping he would be open to V. No go - just not a leader in his field, let's put it that way. Maybe I pass this along to him with a note as to why I may be looking for a new doctor.
Zu - thanks for keeping the science investigations of EPA at the forefront. It really improves the ratio of science info/investment chatter here on the board! (Esp. with JL MIA).
This last post of yours shows great promise for EPA, and not just in the CVD arena.
In the future, a little more patience with us "longs" would be greatly appreciated.
Despite JL's inability to raise the PPS of AMRN, I am sure many others will agree that his posts are routinely some of the most informative on this board.
The absence of JL's input is a considerable loss, especially to those of use with little or no medical background and little experience in investing.
There are a number of other regular participants whose input has good value (regardless of their inability to affect the PPS), and I look forward to hearing from them on a daily basis.
I, for one, sincerely hope JL is simply taking a much needed break from iHub, and will return soon.
Even if AMRN has a "takings" case against the FDA, I don't believe they feel strong enough to take the issue to a judicial level. If so, I think they would have made a final appeal, to exhaust procedural avenues.
Like HD, I now believe our best short-term hope lies with the FDA’s upcoming response to the Senate Committee. And perhaps AMRN does, too. Here's why:
The Committee’s recent directives did not arise out of nowhere – they resulted from mounting industry concerns about how the SPA process may affect their research plans and general operations. These concerns are directly attributable to AMRN’s SPA woes.
The Senate Committee’s demands for clarification of the FDA’s policy for canceling SPA’s should point up several issues: 1) how the FDA defines a serious scientific concern about efficacy, 2) how the FDA communicates those concerns to sponsors, and 3) if the FDA is open to revising their SPA management going forward (including conflict of interest on advisory panels).
Since these issues expose the FDA to additional legislative scrutiny there is the potential, as HD has pointed out, that the FDA may regard the AMRN debacle as a procedural error.
A compromise hammered out via legislative pressure may be much faster and much less expensive than appealing to a judicial body.
And even that is the best possible scenario, if you ask me.
Even better would be prescriptions going up faster, and continuing studies prove the effectiveness of various EPA and trigliceride lowering therapies.
Here is my cautiously optimistic take as we head into the new year:
There are many reasons AMRN's sales have been lackluster, and we wish the medical community would be a little more progressive in accepting Vascepa as a great preventative drug. If that changes, it may not change on the same slow climb we’ve been experiencing.
But the lynchpin of AMRN’s current woes is clearly the FDA, and most importantly, the rescission of the SPA.
The SPA mechanism currently allows a federal agency the ability to inflict serious harm on a private company for no compelling governmental reason. (In my opinion, there are strong parallels here to Fifth and Fourteenth Amendment protections against government “taking” without legitimate government interests and without fair compensation.) This needs to change.
It is currently understood that the SPA rescission is based on the agency’s interpretation of congressional statute, regarding efficacy of the product in terms of the outcomes for a particular population. (HD repeatedly makes very good points here.)
However, there are several potential weaknesses with this regulatory approach:
1) FDA may not be interpreting [url][/url][tag]insert-text-here[/tag]the SPA language entirely in good faith and/or entirely correctly.
2) FDA may not have provided due process[url][/url][tag]insert-text-here[/tag] in the activities that led to rescinding the SPA. (Notification to AMRN, ADCOM management, conflict of interest issues, timing of regulatory actions, and even a legitimate appeals process, appeals timing, etc.)
3) FDA may not have a compelling government interest[url][/url][tag]insert-text-here[/tag] in rescinding the SPA, regardless of the SPA language. That is to say, the “efficacy” language of the SPA protocols may be constitutionally and/or legislatively unsupportable.
If any of the above arguments are found worthy, then,
4) FDA has not provided any compensation to the corporation for rescinding the agreement. (Music to BioBill’s ears, I’m sure!)
The Senate committee appears to be attempting to shed some light on this issue. Hopefully, the outcome won't be a complete rubber stamping of the FDA’s activities. (You can bet lobbyists have been trying to call upon these elected officials to discuss their clients concerns, and it may be a broad-based concern.)
In its response to the Senate committee, the FDA may well find it extremely difficult to explain its recent SPA actions in a manner consistent with either the original intent of the statute, vis a vis other SPA decisions, or in a manner that satisfies the current Senate. However they respond to the Senate committee, there must be greatly concerned with exposing the Agency to potential claims.
As for the appeals process, as we all know, AMRN announced four months ago that they wish to forego the last step of the appeals process. However, if it came to a court of law, I’m not sure the final appeal would qualify as due process, since the appeal would go to a party that has already weighed in on a previous appeal. So in a way, a court of law may perceive that AMRN has already exhausted their appeals, in terms of due process. (Wishful thinking, perhaps, but it’s conceivable. Requiring an appeal to a body that has similar individual participants stretches the credulity of “due process.”)
Most of the important moves in the near future are up to the FDA. I do have some modest hope that there will be some level of compromise on their part. Even the much reviled Adam F has said as much.
It is truly in the FDA’s best interests, and in the interests of the general public, to make some compromise with AMRN that will allow expanded marketing of a safe drug that has proven effective in reducing triglycerides and other markers that current scientific studies have shown to be associated with elevated risk of a cardiovascular event.
In the meantime, AMRN has set themselves upon the task of selling to their initial market, and although progress has been slow – for many reasons outside of their control – sales are continuing to improve, and competing sales are beginning to show weakness.
As for improving the balance sheet long-term, it may not depend entirely on whether AMRN must wait for REDUCE-IT interim results. It could also hinge on general sales, broader acceptance in the marketplace, and – yes – even official compromise on labeling for the product.
There is also the hope that the NCE suit will be positive. And, as long as research continues, there may be growing impetus for success in other areas, such as diabetes, fibro-myalgia, arthritis, dry eye syndrome, hepatitis, depression, etc…
Finally, it appears that management has wisely opted to concentrate their efforts on areas where they have the most potential for success: escalating sales, cutting costs, pressing for regulatory outcomes and protecting their many patents.
As you can see, I have plenty of hope for AMRN’s chances in 2015 and well into the future.
Question: Given new information on Lp-PLA2 and niacin, do you think the ADCOM vote might have gone differently? If so, do you think the FDA realizes this?
I don't agree that American agencies, docs, etc. see the Japanese population as so significantly different from Americans that they would reject a study as serious and compelling as this one.
Let me put it this way: If the study had shown no benefit from increased EPA levels, we'd all have great reason to be dismayed. However, that is definitely not the case!
Please, let's focus on the actual results of the study, not the perceived biases of local agencies. This is definitely a study to bring to official attention.
Let them write their own conclusions, let's not do that for them.
Kiwi, very true:
"these data alone are not sufficient to influence therapeutic decisions .We await further study to conform these initial observations "
However, my point is that while this study is not conclusive, it is another significant entry onto the ever-growing list of indications that EPA has great CVD-related potential. FDA letters in the past have mentioned something to the effect of trying to stay abreast of contemporary developments in EPA-related research as they reach their decisions. More reason for them to consider expanded label, for instance.
You also commented earlier on EPA levels in blood being different for the Japanese population, but my reading is that the diffential of EPA levels was directly correlated to outcomes. Not so much a "how much" EPA there is as a population, but how different EPA levels match up with outcomes.
Anyway, your input is very good, I appreciate it.
Due to the nature of this study, it's hard to believe larger studies are all that feasible, or even warranted. Even the "Japanese" argument is weaker than JELIS.