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Absolute lunacy for any 'fish oil' (DHA + EPA) product to be mentioned in the same breath as Vascepa (pure EPA). DHA and EPA are close cousins but nothing more due to the differences in their respective molecular structures.
Calcium and Magnesium may be close cousins and be in the same group in the periodic table, but they have completely different physical and chemical properties. You cannot interchange them and substitute one for the other, and nor can you combine them and expect the same chemical and physical effects. Same deal with potassium and sodium.
And that's even before we get into the clinical data which clearly differentiates EPA from DHA, and DHA + EPA formulations, and proves EPA to be far superior.
This would be a nice MACE comparison study:
20k patients at high risk of heart disease:
LDL-C median >130mgs/dL and <180mgs/dL;
HDL-C median <45mgs/dL;
TG's median <500mgs/dL;
hsCRP median > than or equal to 2;
5000 patients on only a supplement fish oil (180mgs EPA 120mgs DHA /g) at a 4g dose
vs
5000 patients on a Vascepa 4g dose
vs
5000 patients on a statin
vs
5000 patients on a statin + Vascepa 4g
Don't hold your breath waiting for the NIH to fund the study though.
It doesn't matter what you believe about LDL-C. What matters is what the FDA believes.
Indeed. What a bizarre planet.
Thanks. I see what you are saying. I hadn't noticed that the http://www.vascepahcp.com/ website was "For US Healthcare Professionals Only".
Seems like we're back to the 1st Amendment/FDCA thing again:
https://en.wikipedia.org/wiki/Federal_Food,_Drug,_and_Cosmetic_Act
No R-IT data on the https://www.vascepa.com/ website because Amarin are not allowed to advertise the data to the general public without FDA approval presumably.
Precisely. 2 excellent websites already exist.
https://www.vascepa.com/
http://www.vascepahcp.com/
How do you top those?
https://www.vascepa.com/
Enough said.
"No clue what you're talking about."
Dear oh dear. Ok Raf. Enjoy your day.
But not everything JT says is correct, is it? And not everything I say is correct either. All just opinions Raf. Opinions.
Thanks. I'll have a gander. Too many brain farts and sound bites on Twitter for me. I'm not into the limited word count at all. Same goes for StockTwits but each to their own. Fortunately I can access the content of both without having to be a member of either.
Twitter? I don't use twitter. Never have, never will.
More business for Abrams?? I sincerely hope Amarin have no further dealings with that wonderful man :D Nice to know Amarin have his number on speed dial though.
It seems ADCOM's can still be called for by the FDA even when under Priority Review:
https://globenewswire.com/news-release/2018/06/15/1525173/0/en/Insmed-Announces-FDA-Advisory-Committee-Meeting-to-Review-ALIS-as-a-treatment-for-NTM-Lung-Disease-Caused-by-MAC.html
I'm not sure my marbles are strong enough to go through with another ADCOM :)
The will get Priority Review IMO.
The 1992 Prescription Drug User Fee Act (PDUFA) established a two-tiered system – Standard Review and Priority Review.
Standard Review is applied to a drug that offers at most, only minor improvement over existing marketed therapies. The 2002 amendments to PDUFA set a 10 month goal for a standard review.
Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where none existed. The goal for completing a Priority Review is six months.
Which category do you think Vascepa and R-IT fits into best? If March is the 3rd month, and it takes 6 months, that would fit snugly "into getting approval in 2019". Wouldn't it?
https://www.fda.gov/ForPatients/Approvals/Fast/default.htm
He said sNDA filed by the end of Q1 2019. I'm assuming that means towards the later half of Q1, mid-February to mid-March type of thing. Fits perfectly with the time-frame OldYella estimated.
"Amarin will likely get a written offer prior to the submission of the sNDA IMO. I don't think it will be acceptable. I think Amarin raised cash to eliminate the Europe upfront cash possibilities and keep both US & Europe in a single package."
Exactly what i'm thinking. Interesting to hear him say that the majority of investors that he met yesterday were advocating that they wait until after the sNDA is filed, and "keep flexibility", before signing off on any European partnership. You're looking at March for the sNDA filing IMO.
The cash raise means that they are now well positioned to take their time negotiating a partnership, and also well positioned to GIA. A BO offer in January or February is highly probable IMO as the acquiring company will want to handle Europe themselves.
Lovaza raises LDL-C by 45%.
The whole point of statins is to decrease LDL-C.
High LDL-C is associated with higher CV risk.
This is the reason why a CV outcomes study was never performed on Lovaza (and it is a wonder to me how Epanova managed to slip through the net given that it also significantly raises LDL-C ), and as a result, it has no CVOT data proving it is worth taking to reduce MACE, and it will never have any.
Vascepa had a neutral effect on LDL-C in the ANCHOR trial.
In R-IT it raised LDL-C by measly 3% and achieved an RRR of 25%.
And you are telling me there is an argument to keep prescribing generic Lovaza to patients?
I have my suspicions that Dr. Bhatt and Amarin are all over it already :)
Thanks for the comment.
"Dr. Bhatt’s presentation of R-I results (Vascepa works because it is right composition in correct dose administered to the patient population in the trial) was easily understood by us who were there that afternoon."
Those is attendance understanding is great, but the message now needs to spread to those not in attendance who are still completely oblivious to Vascepa and R-IT and still prescribing generic Lovaza. As a matter of public health it should not be up to Amarin and their limited number of sales reps to try and educate these doctors and cardiologists.
The AHA issued a 'Science Advisory' in 2017 re O-3 supplementation and the prevention of CVD:
https://www.ahajournals.org/doi/abs/10.1161/CIR.0000000000000482
High time they issued another one to reflect the R-IT NEJM data wouldn't you agree?
"...a Citizen Petition for an all out Dear Provider letter from FDA. I think it's a clear public safety issue that generic Lovaza sells into Vascepa market. I could see if Woodcock would respond to some questions on this?"
Well, it certainly won't do any harm. If good medicine and health are the FDA's objectives then they should easily find a way of making this type of communication to doctors and cardiologists in a manner that does not denigrate/undermine/whatever the word is that i'm looking for/ its regulatory role prior to an official decision on label expansion.
Nobody on the planet can argue that patients are better off staying on generic Lovaza while Vascepa remains sitting on the shelf until official FDA approval. There is no scientific rationale for it whatsoever. I doubt even TEVA would argue with it.
Thanks. Purely from a safety and efficacy standpoint there is no reason whatsoever for the FDA not to 'buy-in'.
'Amarin needs to sell the crap out of Vascepa up-to the above catalyst.'
You know what would help with that? If the FDA and/or the AHA issued a memo to anyone currently prescribing generic Lovaza and advised them to switch patients over to Vascepa. If I see them do that i'm sold and will remain all in. But by next April if weekly Rx's are still under 50k i'm gone :)
Thanks. I personally don't have the patience to wait another 2-5 years but I certainly appreciate that GIA is by far the best scenario in terms of maximizing shareholder value long term. My hope is for a BO within the next few months for the simple reason that BP can get this drug over the regulatory hurdles and to the masses far more quickly and efficiently than Amarin could ever hope to. So a BO might only be for $40 or $50 and I miss out on $100-200+ potentially in a few years. Well, boo hoo. My target for the share price was $7, so $40 or above and i'm over the moon personally, and certainly won't be crying and lamenting over what could have been. The patients will get the drug and ill get a nice chunk of change. Win win for me, but each to their own. GIA and I cant see how the share price and market cap dont take a major hit while we're waiting for the multi-billion $$'s in sales to be realized.
Nice post. Any predictions on if/when they get a BO offer? Any price prediction?
If the company isn't sold within the next few months i'm bailing. Far too many other opportunities in other stocks out there and far too many uncertainties with Amarin with the 'go it alone' route.
What happened?
Interesting article here that I hadn't seen before:
http://www.impactpharma.com/blog/fda-change-the-way-it-regulates-off-label-promotion/
"When it comes to off-label promotion – promoting a prescription drug for a use that is not included in its approved labeling – the FDA has historically taken the position that doing so risks criminal misbranding of the product under the Food, Drug and Cosmetic Act (FD&CA). However, a number of recent court cases challenging this position on the basis that it violates the First Amendment rights of drug companies have paved the way for a potential change in the way FDA will be regulating off-label promotion. We are eagerly awaiting the release of a new FDA guidance on off-label communication......."
Still a gap between 18.13 and 19.39 that needs filling but I can't see any immediate rush to fill it. Lots of cheap shares still to be had at lower prices before it reaches the 20's again IMO.
The November end of month close at $18 tells me that there must have been big selling going on in October. The pros sell when the price is rising and the retail traders are busy fantasizing about fancy automobiles and yachts. During October we reached a high of 23.10 with an end of month closing price of 20.83.
As a bull, I wanted to see a closing price of 20.83 or greater end of November. This would have told me that the October selling had been absorbed, and the share price would now continue to rise. But it didn't. It closed at 18 on the button, well off 20.83.
Based on what i've observed in my TA over the years, this kind of price action is very bearish 9 times out of 10, and I would be looking to sell all my shares this month. But strangely, there was also huge volume on the November price bar. It went as low as 13.56 but recovered to close at 18 which tells me that there must have been big buying during November from the professionals. The pros buy when the share price is dropping like a stone and retail traders are panicked with knots in their stomach worrying.
The pros would obviously only be buying if they considered the share price to be now very good value at $13-18 which is where most of the buying has been happening as far as I can tell. They obviously must be expecting much higher prices. To confirm that this was indeed buying rather than continued selling, you now want to see the share price close at $18 or above end of December. If it does then that's a very bullish indicator going into 2019 based on the TA methods that I use. My thinking is that the pros knew that dilution was in the works with only $82M cash on the balance sheets, so prices were stalled in the low $20's because they knew they could slam the prices down after the dilution announcement and pick up more cheap shares.
The S&P500 still has a gap to fill below between 263.25 and 265.34, and share prices tend to move in sync with the parent indexes so I expect that gap to be filled and Amarin's share price to drift down towards the $16's again along with the S&P, as the pros continue to accumulate more cheap shares. Why buy in the $20's when you can buy in the mid-teens? It wouldn't surprise me to see prices in the $15's or even $14's within the next couple of weeks.
JMO based on my own TA. I'm long the stock.
Exactly. It's just an exploratory study. If it's successful it adds weight to the plaque reduction MOA argument. If it doesn't, they will look elsewhere at different MOA's. There's no downside to a failed study outcome.
Completely agree. All the big biotech and their lawyers have misinterpreted the law up until now? I aint havin it.
"The Evaporate study does not have multiple criteria and primary,secondary and tertiary endpoints.....There is only one endpoint: reduction in plaque with Vascepa..."
Incorrect according to the information on the clinicaltrials.gov website:
https://clinicaltrials.gov/ct2/show/NCT02926027
Primary Outcome Measures :
Progression rates of low attenuation plaque under influence of Vascepa as compared to placebo. [ Time Frame: 18 months ]
Secondary Outcome Measures :
The morphology of non-calcified coronary atherosclerotic plaque (NCP) [ Time Frame: 18 months ]
markers of inflammation (Lp-PLA2) [ Time Frame: 18 months ]
changes in markers of inflammation
changes in markers of LDL and HDL cholesterol [ Time Frame: 18 months ]
changes in markers of cholesterol
The composition of non-calcified coronary atherosclerotic plaque (NCP) [ Time Frame: 18 months ]
Sonam,
I never heard of him to be honest. I had a shallow dig and looks like he's high up the retail elites ladder. I have zero interest in oil and gas as forms of energy and am far more of a Nikola Tesla man myself, without going into too many details :)
I had a look at Kukes' SEC filings and looks like he still holds around 7 million shares in Amarin. I see only one sale of 20,000 share so I assume he still holds the rest. At this stage, as a multi billionaire, his 7 million shares at $18 represents 'chump change' to him i'm sure. I'd say he knows a thing or two about mineral oil given his background, and no doubt he knows icosapent ethyl inside out with his chemistry background :D
No idea what he's doing in PED though. I had a look at the stock chart and I wouldn't touch it personally.
Thanks for the MJ song. I'll see your 'hottie on a ducati' and raise you a 'hottie on a bugatti' :D
Enjoy the rest of the weekend.
"It's rarely a good sign when a CEO quits with a stock near 52-week lows. When Amarin announced its CEO Joe Zakrzewski's "retirement" at age 50, let's just say it raises an eyebrow. Here's a guy that once stated, "If you offer me $15 a share, I am waiting. If you offer $30, $40, $100 it's a different story."
https://www.aol.com/article/finance/2013/12/19/did-amarins-ceo-leave-with-his-tail-between-his-le/20792144/
I note that Amarin have an office in Dublin, Ireland still, and to my knowledge Amarin is registered as an Irish company. Does anyone know if Ireland's very low 12.5% rate of corporate tax has any significance?
Too far back. I thought i'd be in and out in a year or two but the plot kept thickening.
This Buffett quote springs to mind:
“If you aren’t thinking about owning a stock for 10 years, don’t even think about owning it for 10 minutes.”
I beat you by a month! :D
I first heard about Amarin in a small article in the business section of an Irish newspaper that they were giving out free copies of. I didn't buy newspapers back then and don't buy them now, so it was pure random chance. The article said that they had just joined the Irish Stock Exchange (ISEQ) and for no particular reason I said to myself that "I need to buy this stock." So I did, with no DD whatsoever about how much cash they had or how they were generating revenue. :D Those were the days.
https://www.rte.ie/news/business/2006/0711/78198-amarin/
I have no idea i'm afraid, but considering the efficacy and safety data in the R-IT trial, and the fact that there is an unmet medical need in the target patient population, and so many people could benefit from being prescribed Vascepa immediately, the whole process should be expedited. No reason whatsoever why FDA bureaucracy should delay the label expansion.
Yes, you could say that :D
Thank you sir.
The whole thing is far too ambiguous for my liking which is why I try and stay as far away from legal matters as possible. There's simply far too much that is open to interpretation and 'opinion'. You can even see it printed on Judge Engelmayers court docket on page 1: 'Opinion & Order'
http://www.fdalawblog.net/wp-content/uploads/archives/docs/Amarin%20Decision%208-2015%20Off-Label.pdf
Your opinion could of course be correct but the part that i'm most wary of is not the FDA but the FDCA. I don't have the patience to look into the codes (the language amounts to babble and it gives me a headache) but if you did I think you would find the relevant information there.
From the link above on page 3, 4, 5:
"Before 1938, drug manufacturers could market drugs without premarket approval for safety or effectiveness. In 1938, a year after more than 100 Americans died after ingesting a toxic drug (elixir sulfanilamide), Congress enacted the FDCA....In response to rampant false and misleading advertising of drugs, Congress amended the FDCA by enacting the Drug Amendments of 1962. These require manufacturers to demonstrate
that their drugs are both safe and effective for their intended uses before they are approved for distribution. Specifically, the FDCA, as amended, provides that: “No person shall introduce or deliver for introduction into interstate commerce any new drug,” without the FDA’s
approval of a “new drug application,” which must demonstrate the drug’s safety and efficacy through a series of pre-clinical and clinical trials, and must indicate the proposed labeling for the drug. FDA approval is therefore necessary before a manufacturer can
distribute a drug. Significant here, however, the FDA does not regulate doctors."
Will be interesting to see how it all plays out anyway.
A discussion with Herper, Nissen, a former FDA Commisioner and 2 other guys who don't appear to be particularly fond of Nissen's opinions:
A nice video here from Dr. Cannon, a Professor of Medicine at Harvard who has worked 30 years in the Cardiovascular Division at Brigham and Women's hospital. He is speaking in October before the AHA meeting:
I agree with your 1st Amendment sentiments but i'm still with dmiller on this one. No doubt Amarin is desperate to advertise to the masses but I believe they will be severely restricted until the FDA approves the labeling. There may be ways minor ways around it in how they can tweak their adverts but they can't make any claims or statements relating to safety and efficacy outside the MARINE indication until the FDA approve R-IT IMO. Any claims that they may make will have to be followed with a 'These statements have not been evaluated by the FDA and Vascepa is not intended to blah blah blah....' which kind of defeats the purpose of making them in the first place. If they try to get too fancy and creative the FDCA will come down on them like a ton of bricks.
There is absolutely no reference to the ANCHOR indication in this advert and for very good reason IMO:
Will be very interesting to see how the script numbers increase over the next few months. Doctors already familiar with Vascepa and already prescribing it off label before the R-IT results will now be very comforted by the efficacy and safety data published in the NEJM, and now may be far more inclined to prescribe it to more patients. They certainly won't be taking patients off it now that's for sure.
Then you have the 2000+ in attendance at the AHA presentation, many of whom may have been too cautious to prescribe Vascepa before R-IT who should also now start prescribing it on the back of that efficacy and safety data.
Then there's all the new Amarin sales reps who will be let loose in January after they are done training who will have the NEJM data in hand.
Then there's my favorite bunch, the generic Lovaza brigade, who now have no reason whatsoever to continue to prescribe a vastly inferior product that significantly raises LDL-C. Would be nice to see the AHA step in and say something official on the matter because all those Lovaza patients should now be on Vascepa. Immediately. No exception. Do they care about patient's health or not? Are Amarin going to have to wait years until the AHA get their act together while they wait for the FDA to get their act together?