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I found this:
"The company sued, arguing that the threat of prosecution for misbranding has a chilling effect on commercial speech protected by the First Amendment. It sought an injunction prohibiting the FDA from bringing a misbranding action for Amarin’s truthful and non-misleading statements regarding Vascepa® directly to healthcare professionals—not in direct-to-consumer advertising. Specifically the company wanted to affirm its right to disseminate study results; report supportive but not conclusive research shows that their product may reduce the risk of coronary heart disease; and distribute reprints of peer-reviewed scientific publications relevant to the reduction of the risk of coronary heart disease. The company was willing to do this along with “contemporaneous disclosures” to ensure that the messages Amarin communicated to doctors concerning the use of Vascepa® in patients with persistently high triglycerides was not misleading."
https://www.lexology.com/library/detail.aspx?g=b7c22f1e-0245-40fc-8902-d304f54de762
It was an interview by the CEO on a prominent financial network hot on the heals of the companies home-run outcome study data. Not sure you can compare that with a mass advertising campaign across network TV aimed at the masses.
Absolutely spot-on. 100% correct.
He's right. It doesn't threaten statins and won't threaten statins until a direct head to head outcomes study pitting Vascepa vs statins is done.
For now, when taken with a statin, Vascepa basically enhances the effect of the statin.
Couldn't be much further removed from the mistaken idea that it somehow interferes negatively with statin function.
I've said it before and i'll say it again. EPA is a very very powerful anti-oxidant that has very powerful anti-inflammatory effects.
Look at the hsCRP data from the R-IT trial. hsCRP is a great way to measure inflammation. In the Vascepa arm the hsCRP went down from 2.2 to 1.8 (nearly 13% and under 2 which is exactly where you want it-the lower the better). When you consider that the patients in both arms of the trial would have been consuming a very similar diet (a pro-inflammatory one), the results become even more impressive. In my opinion you still would have had a tendency for an increase in hsCRP in the Vascepa arm that was highly comparable to the increase seen in the placebo arm, but this increase in inflammation was completely offset by Vascepa. A hsCRP value of 2.2 would have been impressive enough but it didnt stop there - it reduce the hsCRP even lower again to 1.8.
Lets be exceedingly generous and attribute 0.1mgs/dL of the 0.7mgs/dL increase in hsCRP in the placebo arm to mineral oil (very slight inflammation to the gut, liver). So you are then attributing the vast majority of the increase in inflammation to the patient's highly inflammatory diet - which is by far the most sensible and logical conclusion. You could then say that in reality, Vascepa actually reduced hsCRP from closer to 2.8 to 1.8! (2.2 baseline plus 0.7 placebo arm minus 0.1 mineral oil=2.8)
Anyone looking at the placebo arm for the reasons that this trial succeeded will be looking a very long time (probably well into eternity by my estimates), and they won't find anything of any real note.
And anyone looking at the failed fish oil low dose EPA DHA studies will also come up well short trying to find anything there.
The only trial out there that has any relativity here is JELIS.
It's the EPA and the dose.
Just read it there. That was excellent journalism - well balanced, well written, and factual.
"Rory Collins, the head of the Nuffield department at Oxford , argued in an email that other factors could explain the increase in cholesterol seen in the placebo group. One factor is that low cholesterol was required for patients entering the study. That could have meant that researchers were picking people at what was a low cholesterol level for them, and the levels simply returned to normal. (This is called regression to the mean.) It also could be the result, he says, of statistical quirks because the tests weren’t collected in random order — and effect that researchers could test for by going back to banked blood samples.
“An effect of the mineral oil remains a possibility, but my guess would be that it is largely if not wholly an effect of the high-dose EPA through mechanisms beyond merely lowering [triglycerides],” Collins writes. He poses a provocative question: what if the Vascepa study, called REDUCE-IT, is to EPA what a 1995 study called 4S was to cholesterol-lowering drugs called statins?"
There's a guy that is very clued in :)
I'm very much looking forward to the language that he uses because he should probably be very very careful what he writes. Let's see if he's as smart as he thinks he is.
I know exactly what you posted - a bunch of data that has no relevance to R-IT whatsoever. None.
I saw you do the exact same thing over and over again with the omega 3 studies trying to find a reason that R-IT would fail spectacularly. Do you want me to go through your posts and remind you? Because I can.
This is the way it is.
You have intelligence. You are scientifically literate. You know your way around the scientific papers. But you only have about 50-75% of the jigsaw puzzle pieces. I have over 95% of the puzzle pieces and I have pieced them together correctly so reveal the correct picture. You not only don't have a enough jigsaw pieces, the pieces that you do have you have tried to fit them together in a way that makes the picture that you want the pieces to make. This is why you predicted R-IT would fail spectacularly and I predicted the opposite as is evidenced by the common stock I owned before the trial results were announced.
It's as simple as that.
You are going to miss out here on a massive uptick in the share price ultimately, and im trying to help you see the light. But if you know better than I do, better than the baker bros do, better than all the other hedge funds with their team of PhD's do, better that Amarin the FDA and Declan Doogan does, then so be it......It really isn't of any consequence to anyone other than yourself.
Best of luck with your trades. I know you will make a killing shorting NWBO. Very smart move (im not being sarcastic, it's a total turkey of a stock).
Down into the $16's pre-market. A Herper article on it's way. Storm is a brew perhaps. Let's see if they don't slam this down to the $14's again by Thursday.
"In the study it shows clearly, in a controlled setting, what reductions in LDL-C and other inflammatory markers (non HDL-C) you can expect to see from various statin doses, from low, to moderate, to high dose." Yes, agreed!
The point that you are missing is that those reductions are applicable to patients who are highly inflammed and starting out with astronomical LDL-C levels of 190mgs/dL at baseline. In R-IT the LDL-C is already optimal at 75mgs/dL -it can't go much lower! Go look at studies and see what happens when you slam LDL-C down below that. There's a reason that the 70-99mgs/dL range is the range targeted.
It is common sense. Simple logic. There has to be some boundaries otherwise it would just be a free for all rendering the FDA pointless. For an indication this size there's no way in hell Amarin can just go slather the R-IT data across bill-boards, TV ads, websites and all the rest without the FDA approving the indication first.
"Amarin “bears the responsibility, going forward, of assuring that its communications to doctors regarding off-label use of Vascepa remain truthful and non-misleading.” To this end, the agreement also provides a special procedure through 2020 in which FDA will give Amarin advance review for as many as two promotional communications annually about off-label uses of Vascepa."
The above refers to conference poster presentations aimed at doctors and cardiologists, and sales rep promotional material. Has nothing to do with mass advertisment to the general public in my opinion.
"FDA will be pressured to approve the label extension anyway, because if denied and Vascepa proves itself in the market off-label, FDA will have egg on its face."
A valid point. Don't forget that Amarin have been accumulating a buttload of Real World Event data which will further support their cause and increase the liklihood of approval - RWE data without any placebo in sight may I add :)
I think your interpretation is correct. The marketing of results refers to what Amarin provide it's sales reps with. They can update and change this promotional material twice a year after running it by the FDA first.
No way they can advertise the R-IT results via the mass media without FDA approval of the indication first.
God help your soul when Raf sees this :D
I just remembered this detail from the 1st amendment victory:
"This week’s settlement agreement stipulates that “Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa…and such speech may not form the basis of a prosecution for misbranding.” However, Amarin “bears the responsibility, going forward, of assuring that its communications to doctors regarding off-label use of Vascepa remain truthful and non-misleading.” To this end, the agreement also provides a special procedure through 2020 in which FDA will give Amarin advance review for as many as two promotional communications annually about off-label uses of Vascepa. Moreover, the agreement establishes a specific process for resolving any concerns that FDA voices about those communications prior to the parties returning to court."
https://www.mintz.com/insights-center/viewpoints/2016-03-amarinfda-settlement-significant-first-amendment-victory-label
About time Amarin got some their 'promotional communications' updated to include the NEJM published R-IT data wouldn't you say? :)
You've gone off the deep end there with that post. You're trying to fit a square peg into a round hole.
Are you aware that the patients in R-IT already had their LDL-C at optimal levels at baseline (75mgs/dL)? What has the STELLAR data got to do with anything? The baseline LDL-C levels in those charts are all around 190mgs/dL!
Appreciate the info, thanks.
The script data will be fascinating to see over the next month. Has always pained me seeing the huge chunk of market share that generic Lovaza takes away from Vascepa every week - not to mention all those fenobibrates and other TG lower drugs that have no cardiovascular outcomes data.
Then you have that China deal which is starting to look very tasty. Once that P3 trial gets approved there should be massive sales there on the back of the R-IT data:
"Terms of the agreement include up-front and milestone payments to Amarin of up to $169.0 million, including a non-refundable $15.0 million up-front payment and development, regulatory and sales-based milestone payments of up to an additional $154.0 million. Eddingpharm will also pay Amarin tiered double-digit percentage royalties on net sales of Vascepa in the territory escalating to the high teens. Amarin will supply product to Eddingpharm under negotiated supply terms.
The Chinese pharmaceutical market has been growing at an annual rate of approximately 20% during the past ten years and currently is the third largest pharmaceutical market in the world."
http://www.eddingpharm.com/content.aspx?id=62
Exhausted the human data and on to the rat data now I see :)
I had a read of that paper. Not the finest effort i've ever come across but I enjoyed it nonetheless. I've actually been to Karnataka in India. I can't say that i'd ever go back. Kashmir and Ladakh on the underhand blew my mind. The scenery is like a Disney movie in them parts. Amazing. But I digress...
Back to that paper.
"Non-digestible lipids, including mineral oils, sucrose polyesters and others, are not absorbed from the gut lumen." This claim is not referenced in the paper.
So where do suggest the lipogranulomas in the liver come from then?
https://www.ncbi.nlm.nih.gov/pubmed/7102605
"The reason for this peculiar location remains unexplained. Our data from lipid histochemistry and analysis of lipid extracts from the livers and foodstuffs by thinlayer chromatography and gas-liquid chromatography indicate that LG in NFL most likely represent a reaction to absorbed saturated hydrocarbons, like mineral oil, used widely in the food industry."
Exactly. And couldn't you then propose that it is DHA that is somehow inhibiting statin function? Yes. Yes you could. And it wouldn't be too hard to prove it either ;)
Interesting.
What kind valuation would you put the market cap at by the end of 2019 considering $1B in revenue? I don't see $2B personally without insurance coverage and FDA approval. 4X sales? 10X? How is that determined? I've looked at Sarepta's market cap and valuation and its ridiculous relative to their sales so I can't make head nor tail of how these valuations are arrived at other than conservative speculation vs wild speculation. 'Perceived value' seems to far outweigh 'Intrinsic value'.
Thanks.
Thanks. I previously stated that Epanova was garbage. A slight exageration - garbage relative to Vascepa. It does have some redeeming features obviously. The fact that it raises EPA levels isn't surprising - it's 55% EPA :) The problem is that it also increases LDL-C. In the 4g dose of that trial the LDL-C rise was off the charts! That does not bode well for the STRENGTH trial.
St. John's Wort? Yes, it would cause interference with a statin because it has medicinal properties and is not inert. Allopathic medicine has its roots in the use of herbs. Up until the 1930's or thereabouts, nearly all the entries in pharmacopoeias describing the manufacture of drugs indicated a herbal origin. Mineral oil does not have a herbal origin. It is a waste product from the petroleum industry and has been used for hundreds of years as a mild laxative. You're gonna need to step up your game here.
This is the guy responsible for choosing the mineral oil placebo:
https://www.biohavenpharma.com/about-biohaven/board-directors#declan-doogan-md
He is no lightweight:
"Declan Doogan is a veteran of the pharmaceutical industry. After gaining his basic medical degree of MB. ChB. From Glasgow University, he went on to become a Fellow of the Royal College of Physicians (FRCP) and later was awarded Fellowship of the Faculty of Pharmaceutical Medicine in the UK (FFPM). In 2001 he became Doctor of Science (DSc) at the University of Kent.
He is the former Head of Worldwide Development, Pfizer Inc. from which he retired in 2007. During his pharmaceutical career he led the sertraline (Zoloft) clinical development program leading to its worldwide approval. His groups in Pfizer saw the approval of many $bn selling drugs including Lipitor, Viagra, Zithromax and Revatio. After retirement from Pfizer he became President of R&D and later CEO of Amarin Pharma which gained US NDA approval for Vascepa (EPA for hypertriglyceridemia). He is an investor in several biotech start-ups as well as being the founder of Brain Food (nutraceuticals). Declan is CEO of Portage, a portfolio company developing new drugs using novel protein transporters. He is Executive Chair of Biohaven Pharmaceuticals (New Haven) a company specializing in psychiatric diseases. He is a Board member of Sosei a Japanese biotech as well as the Pulmonary Vascular Research Institute.
Declan’s academic career included Visiting Professorships at Harvard School of Public Health, Glasgow University Medical School and Kitasato University (Tokyo)."
https://www.intelligencesquared.com/speakers/declan-doogan/
You think he didn't do his research on mineral oil and have detailed discussions with the FDA while designing the MARINE, ANCHOR and R-IT trials? You think the FDA didn't do exhaustive research on mineral oil before the ANCHOR ADCOM? This was their conclusion:
"Thus the review team sought evidence that might help explain the changes seen in the mineral oil group. We considered issues with randomization, unblinding, statin absorption, study design elements, and lipid changes seen in placebo treated patients. Our review, did not point to any particular cause for the observed placebo changes."
You haven't mentioned the mineral oil effect on TG'S and HDL-C I notice. How do you account for the those positive movements in the biomarkers? Mineral oil has a small amount of cardiovascular benefit?
TG's: Reduced by 7% after 5 years
HDL-C (the so called good cholesterol which you want to see increasing): Increased by 6% after 5 years
Your placebo thesis is falling asunder my friend.
And whatever about the slight changes in the biomarkers, as the FDA themselves stated at the ANCHOR ADCOM:
"the critical question which patients care about is ultimately, do the observed changes in lipids and lipoproteins with Vascepa while treated with statins translate into a benefit on cardiovascular outcomes." - their words, not mine, and we have the answer now. YES. Substantially.
So you can be appeased! :D Interesting.
Yes, it was brought up at the ANCHOR ADCOM. The FDA said that the placebo lipid values stood out as atypical in the ANCHOR trial which "gave them pause" as the lipid changes went in an unfavourable direction.....
"Thus the review team sought evidence that might help explain the changes seen in the mineral oil group. We considered issues with randomization, unblinding, statin absorption, study design elements, and lipid changes seen in placebo treated patients. Our review, did not point to any particular cause for the observed placebo changes. Therefore, what, if any, implications do the placebo group changes have on the REDUCE-IT and ANCHOR trials. For REDUCE-IT, our primary concern was whether or not there was a possibility that the mineral oil could attenuate the effect of a statin, perhaps by inhibiting absorption. If plausible, this would raise concerns about the potential impact this would have on the ongoing cardiovascular outcomes trial, which is also using mineral oil as a placebo among statin treated patients. Because we do not have any hard evidence for an interaction, such as a formal drug drug interaction study, we discussed our concern with the sponsor and ask that they task the REDUCE-IT data monitoring committee with evaluating the accruing lipid data with this concern in mind."
The DMC did not halt the trial due to LDL-C concerns which they would have been under strict orders to look out for.
They went on to say that "the critical question which patients care about is ultimately, do the observed changes in lipids and lipoproteins with Vascepa while treated with statins translate into a benefit on cardiovascular outcomes".
We now know the answer to this. Yes, by 25%.
You think statins increased from 75mgs/dL to around 95mgs/dL in high intensity statin treated patients? I don't get what you are basing this on.
To my mind you could still theoretically see an increase in LDL-C of up to 30% from 75 to the high 90's and still dismiss it because its still under the target of <100mgs/dL, AND the total baseline only moved by 7 points median after nearly years.
I don't believe that it did though for the reasons ive already stated several times.
Thanks. Interesting. So what kind of revenue projections do people have for 2019? 2018 is gonna be in the region of $250M or thereabouts. So what are we looking at in 2019 bearing in mind that as of yet there is no official FDA approval for the indication, and the AHA haven't officially endorsed Vascepa's use in its treatment guidelines? $500M? Higher? Much lower? I personally haven't a clue.
The reason I ask is because I have held Amarin stock post the ANCHOR trial results when the market cap spiked big-time, and then watched the share price slowly drop for months on end. There has to come a time when Wall St says show me the money and wants justification of a multi-billion $ market cap. Not gonna be an issue if they are bought out but it sure as hell will be if they go this alone as they have done with the MARINE and ANCHOR indications, and are pulling in only $400M/year or less in 2019 with potential issues with the FDA over approval.
Yes, but Herper isn't at the root of the thing - Nissen is. Herper quotes Nissen in his article and both he and Feuerstein are simply parroting and expanding on Nissen's views which hold the most weight in their eyes because he's the principal investigator of the STRENGTH trial and an 'expert' in the field, so his opposing interpretation of the trial data could very well be valid in theory and is exactly what the bears at the hedge funds are after. Whether Nissen has it right or not doesn't really matter, and neither does his conflict of interest with AZN and STRENGTH. The important point is to have a plausibly convincing bear thesis from a reputable source published in a reputable publication (FORBES), because that gives the bear side weight. The hedge funds then just piggy back on the articles and slam the stock down.
Options are of course a factor because the goal is to screw over as many retail traders as possible with as many options expiring worthless as possible. I'm not an options trader and not really sure how that whole thing works but ive been watching it closely the past few weeks and it looks to me as if hedge funds use options to set traps and dupe people with price perception.
The saving grace for Amarin longs is that it looks to me from the volume and price action last week as if the big hedge funds have started accumulating common stock again rather than leaving it for dead. They would only do this if they expected the price to rise higher and considered the share price to be good value at $14-18. They know full well that the data was home-run as do Amgen and all the other BP's - read Feuerstein's second article. A buyout is back on the table now big-time with that R-IT data which is why the shorts bought back in. Feuerstein tells you exactly what's happening if you have the ears to hear. He said there would be sell on the news price action, there's concerns from some with the data but it doesn't invalidate the trial, and a BO is most definitely still on the table. What's wrong with that analysis? Very accurate in my opinion but he gets name called and attacked by disgruntled Amarin longs completely oblivious to how to game is played.
Next week I think they will slam it down again to buy more cheapies but the price will recover by the end of the week and by the end of the month it will be back in $20's. Just my opinion. Maybe im wrong and it gets slammed down and stays there, or maybe it opens in the $18's and blitzes a trail into the $20's next week. I highly doubt it though.
Not quite "night and day" but i'd certainly say that the thoughts have crossed their minds given Dr. Nissen's past track record :) Sanity may prevail. There are patients lives at stake here, not just a boat load of $$$'s.
I did indeed :) Thanks. A great way to set the ol' pulses racing those ambulance chasing lawyers and spook the bejesus out of people.
Yes, equally true with the long side of the trade. I learned that watching Sarepta's huge share price increase the past year with earnings only about the same as Amarin's. The Investment Bank analysts are in on the game as well of course.
The SEC would need to expand its operations by about 100x to keep up.
I'm not so sure he is a crook. He just believes that the mineral oil is not inert and the RRR is inflated by some degree. I respect that. Maybe he is right and i'm wrong, but there is nothing to support his views available in the existing scientific literature that supports his view - which is why he wants to try and create some.
But the truth is that mineral oil causes zero inflammation that is specific to the heart and circulatory system. The liver and lining of the gut - perhaps a very small amount which would account for a very small amount of the % increase seen in hsCRP (which detects inflammation throughout the body - not just the heart) in the placebo arm. The slight LDL-C increase can be accounted for by dietary factors which is what also cause the majority of the increase in hsCRP.
If it was me and I was the principal investigator of STRENGTH I would hold my hands up and applaud Amarin and wish them all the best, crack on with the STRENGTH trial, and leave it up to the FDA to decide if there is any patient benefit and issue with the placebo - after all, they were the ones who approved its use. I hold virtue in high regard and am a firm believer in karma but I fully respect those who don't. The path that Dr. Nissen is taking could be considered to be quite a selfish one but it's far from me to judge him for it. It will play out how it plays out. We reap what we sow. Or not ;)
He just trying to protect his turf. He is a smart guy and has invested a lot of time and effort into his career, building up his credentials and reputation, and also with AZN and this STRENGTH trial. There's a lot riding on it personally for him. Having said that, I wouldn't trust him either going off his past track record.
I hope the STRENGTH trial is a success because it will just add more weight and validity to the prescription grade fish oil paradigm shift in the mind of the AHA, who ultimately determine the standard of practice guidelines. 2 successful outcomes trials holds more weight than just 1 with R-IT vs the slew of all the other failed fish oil studies potentially including Epanova.
Vascepa is the cream of the fish oil crop - and Nissen and AZN know it full well. No way in hell Epanova attains a higher RRR than Vascepa, and no way in hell the blood-marker data in the Epanova arm outdoes the Vascepa arm in R-IT. As mentioned previously, the problem that the STRENGTH trial will have - even if they do attain an RRR of 8-15% (I predict it will be 5-10%) - is the dramatic increase in LDL-C that the data will likely show. If it's anything like the Lovaza outcome study rise in LDL-C the FDA won't approve it no matter what the RRR is. So it's gonna be win win for whichever company owns Vascepa (Amarin or BP) because it will be best in class, and there will be no competition from Epanova despite its modest reduction in RRR.
Namaste! Yes, in advanced disease states Esselstyn's diet works wonders - not a particularly practical diet though :)
Once you stay away from highly processed foods and consume as many high pranic foods as possible instead you'll be fine - lots of fresh, seasonal and organic fruit and veg. If you are gonna eat meat keep it to white meat in smaller portions, and eat it soon after the animal has been killed - chicken, fish, turkey etc
I switch off when I hear the word Brexit :) 1st world problems. Far more important issues going on the world than that im my opinion. They have made a load of money on their cosy European trade deals up until now, and will make a whole load more once they renegotiate their European trade deals with the U.S, Canada, Sth America, Australia, Asia etc etc instead.
Here's a nice one for all y'all.
Dr. Nissen discussing the AHA highlights.
The shorts don't twist the truth, you are correct.
This is how the game is played...
Find a prominent Doctor/Cardiologist who is a Pyrrhonian skeptic type - Dr. Nissen would be the perfect guy - and have him scrutinize the R-IT trial data to find something that he believes is erroneous with the data (whether or not this doc has ties to a competing drug and company is apparently irrelevant) ;)
Vascepa arm - nothing to see there. As flawless a set of data as you will ever see in a cardiovascular outcomes trial, and with bugger all side-effects to boot.
The Placebo arm - a slight uptick in some of the biomarkers, but nothing that even remotely compromises the integrity of the trial.
You could however spin a yarn and concoct a theory (unsupported by any available scientific studies) suggesting that it is the placebo itself that causes this uptick in biomarkers. By extension you could then suggest with apparent plausibility (if you didn't fully understand the science behind EPA, inflammation and all the rest) that the RRR is inflated. To the untrained scientific mind - retail investors etc - this may sound like a valid concern.
Next the story needs legs. Cue Forbes and Herper and to a lesser extent Feuerstein, SeekingAlpha, Bloomberg etc etc
Now all the shorts have to do is ride the wave and slam the Ask. Not one of them has had to twist any truth whatsoever - the media outlets and Dr. Nissen and friends did all the hard work for them.
Quite a fun game you would think.....
Will be very interesting to see how this plays out with so many millions of patient lives on the line here.
HDGabor,
I believe you are the resident financial expert on the message board here.
A few of questions if you have the time to reply.
How long do you believe it will be before Amarin needs more cash now that the major expenses related to funding the R-IT trial are no longer an issue?
Do you think that $82M cash is enough for them to successfully market Vascepa and grow prescriptions to the point that they do not need to raise any cash?
Do you think that they will announce a European partner and receive a lump cash sum?
Regards
Was reading this article about Dr. Nissen:
https://statins.news/2017-08-18-statin-push-quack-steven-nissen-exposed-for-conflicts-of-interest-statin-drug-prostitution-and-science-denialism.html
"In Nissen’s view, any negative outcome from taking statins is the result of the nocebo effect, or what he describes as side effects that only exist within a patient’s head. In other words, nobody is ever harmed by statins, according to Nissen, and anyone who claims to have been is just crazy.
Nissen has accepted cash grants from Pfizer, Astra Zeneca, Amgen, and Esperion Therapeutics."
So it's nocebo related issues one minute, to defend drugs produced by companies that he has ties to, and placebo related issues the next minute, to disparage competing drugs like Vascepa.
How interesting.
Another article here for folks who think im overly paranoid about AZN and Nissen, and their power to influence the FDA:
http://edition.cnn.com/2005/HEALTH/11/01/profile.cardiologist.nissen/index.html
"A week and a half ago, the 57-year-old Nissen again blew his whistle. This time the drug was Pargluva (muraglitazar), an experimental type 2 diabetes drug that can lower blood sugar while also increasing the level of HDL, the so-called good cholesterol, and decreasing triglycerides, a blood fat that increases the risk of heart disease.
When the FDA published clinical trial data about the drug, Nissen immediately spotted something amiss. All the "cardiovascular markers were going in the wrong direction. There were increases in heart attacks, stroke, and cardiovascular death."
One look told him that an FDA advisory panel charged with reviewing the same documents would not approve the drug. But he was surprised when the panel, which met September 9, recommended by an 8-1 vote that FDA give it a thumbs-up. He dropped everything and began an in-depth analysis of the Pargluva data.
Working nonstop with a Cleveland Clinic statistician and with co-author Dr. Eric Topol, chairman of the department of cardiovascular medicine, Nissen finished his analysis in record time.
The paper was published online on October 20 by the Journal of the American Medical Association, just two days after the FDA had sent the drug's makers an "approvable letter" that said Pargluva could be approved if the company supplied more cardiovascular safety data.
On October 27, Bristol-Myers Squibb announced that it would terminate its Pargluva development agreement with Merck. Bristol-Myers Squibb said it will continue discussions with the FDA, but said it might stop development of the drug.
Asked about the stunning reversal of fortune for Pargluva, Nissen said, "I'm not a crusader, I just want the balance between safety and efficacy to be favorable." "
Why do people keep mentioning NWBO? I'd stay well well away from that one folks. Share price looks to me like it's gonna tank. AMRN is where the party is at.
Nail on the head. Thanks.
Comes back to that old Buffet quote - 'Be greedy when others are fearful and fearful when others are greedy'. The time to sell was when the $60-150 price predictions were being bandied about in the low $20's when you started dreaming of Porches and Yachts. The time to to buy was when you had that gagging feeling in the pit of your stomach last week when they slammed it down to the $13's - not referring to you personally :)
They will do the same next week I believe. No shortage of suckers out there.
Good luck against the Irish later by the way - you're gonna need it! :D
Exactly. AZN would still find an issue with the placebo arm even if there was only water in the capsule. So what you gotta go off is the Vascepa arm of the trial and look for anomalies there. The trouble for AZN is that there is none.
After nearly 5 years in the Vascepa arm:
TGs: -22%
non-HDL-C: -4%
LDL-C: +3% (and still well under 80mgs/dL)
HDL-C: +3%
ApoB: -3%
hsCRP: -13%
EPA: +394%
That's as near flawless as you will ever see.
AZN can't believe what they are seeing in the data and have had to resort to inventing a non-existent issue with the placebo arm. Epanova hasn't a snowball's chance in hell of achieving data like the above. LDL-C will be through the roof for starters. I wouldn't be surprised if the DMC halted the STRENGTH trial early due to concerns over the LDL-C increase that I believe they will see.
The basis im using is 'caution'. The FDA in my opinion were overly cautious in not approving ANCHOR as has been evidenced by the 25% RRR. IMO patients could and should have been on Vascepa for the past few years. I have my suspicions that much of that FDA caution had to do with pressure from AZN who have a competing drug and were desperate to hold the Amarin show up. Dr Hyatt had strong ties to AZN and orchestrated the whole show during the last ADCOM. Who's to say with absolute certainty that AZN won't pressure the FDA again in another attempt to stall approval? Maybe i'm wrong and Amarin will breeze past the FDA without perhaps even needing an ADCOM but I personally wouldn't bet a cent on it. It all amounts to a mute point anyway because I think they will be bought out sooner rather than later.
Not necessarily from Feuerstein. Could be Herper again, could be SeekingAlpha, Motley Fool etc etc. Doesn't really matter who.
"What else is there?" Probably something to do with equity financing and dilution, and how $82M cash isn't enough to pay for the kind of marketing push needed to really ramp up sales.
A buyout obviously solves the problem of potential dilution. Another solution would be a nice chunky upfront cash payment from a European partner.
Gonna be an interesting winter though that's for sure.
I personally hope they sell the company. If they go this alone the share price is gonna get a hefty haircut one way or the other because the revenues simply won't support the kind of market cap that they currently have. Yes the sales potential is there but it will be a case of Wall St saying 'show me the money'.
Then you have a potential sht show of an ADCOM with AZN all over the FDA pushing them to request more data before approval blah blah blah, and the FDA potentially bowing to the pressure. They could still get FDA approval of course but I don't trust the FDA enough to hold a large position in Amarin going into an event like that. That ANCHOR ADCOM was like watching a bloody horror movie.
So its a takeover for me within the next 6 months or i'm cashing out. This roller-coaster ride has gone on long enough.
"What more can we ask for to consider this as a great investment?"
A buyout.