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Great to hear! Why are you a shareholder?
How do you think about V peak sales levels then considering your experience and the potential market size of the drug and therefore Amarin as a co.?
are you an Amarin shareholder though?
thanks TTE, keep the faith, elf season will be back (along with Amarin PPS).
Hi Cardio, welcome to the board. Debate is healthy but yes some on here can come across angry, sceptical, histrionic and opinionated. Overall though there are some great and varied points of view across all aspects of Amarin, the science and the trial.
My question to you is; why are you here?
Are you an Amarin stockholder or just a prescriber? Were any if your patients involved in the R-IT trial? If you have written so many V scripts already, I would guess your patients werw?
Also are you testing any additional fasting trig levels to decide Y or N for a V prescription?
The primary endpoint was significantly lower with icosapent ethyl in the secondary prevention cohort (71% of participants) but not in the smaller primary prevention cohort (NEJM JW Gen Med Jan 1 2019 and N Engl J Med 2018 Nov 10; [e-pub]).
But NOT in the smaller primary prevention cohort....what? really ? What devil in the detail am I missing....anyone?
Week to week tracking is futile. Best to look around February time, will be much more evident from then. Too early to judge now.
Per Symphony Health, TRx and NRx Count for Vascepa has grown meaningfully
since pre-REDUCE-IT levels (see chart). Data is updated as of 12/14/18.
n The latest full week script data represents an overall increase in TRx and NRx
values for Vascepa since positive data at AHA on 11/10/2018, but slightly lower
from the previous week.
n This is a YoY TRx and NRx increase of 30.0% and 43.2% respectively, compared
to 12/15/2017 values and WoW TRx and NRx decrease of -1.8% and -3.2%
respectively, compared to 12/7/2018 values.
n It should be noted that weekly results are often variable and particularly true
around holidays. However, there seems to be an overall positive sentiment from
physicians evidenced by numbers continuing to grow over prior year results.
n AMRN remains on track to submit a sNDA to expand its labeling for REDUCE-IT
in early 2019, with approval expected in late 2019.
THANKS as ever Sam.
Good find KevGee, and not even a mention of EPA, does bode well for V (EPA) differentiation - BUT to come out now and not even mention it, how on earth can that come out now and omit V and be considered a serious EMA review. What a disappointment no V acknowledgement...
Certainly not going to defend myself or pick a fight with the self-proclaimed guru of the stock/board, but:
"Raising prices at this juncture is just STUPID..."
I can't wait until JT like the great CEO he is raises prices next year and then while all us shareholders are happy, you then call him stupid for doing it lol
"I love how posters on this site who have contributed nothing but their egos.. try to tear me down."
JL, not going to get into a petulant argument with you. As they say its really NOT PERSONAL - its JUST BUSINESS.
I am very happy to be disagreeing with you here JL.
Even though the soon to be CEO of the year doesn't mention it (smart of him), it would make a lot of commercial sense to increase the price and differentiate V. We all know its better than generic L, PCSK9's etc and therefore it should also be priced that way.
I think you will find just because JT says 'its a volume game' it doesn't preclude a price rise. Most probably similar to him talking about the capital raising they didn't need to have :)
JL, you were great on the science, I grant you that - but its really all about the business now. Amarin need to capitalise on what they have done.
AGREED bfost, lots of impatient fishes out there who are good at timing things within 1 second of predicated announcements based on chart movements lol :)
On the ITC matter well covered by Sonam/oneragman: This seems to be a jurisdictional case. Obviously AMRN testing the law around two big regulatory organisations (ITC/FDA). These things are no small matter as it would set major precedent. It is understandable this is taking more time than usual. Its a very big decision with big ramifications not only for Amarin. My personal view is there will be some communication between FDA and ITC behind closed doors and that in order for the FDA not to lose face or their jurisdictional precedence.. they might come out with some sort of policy where dietary supplements should not be used to treat medical conditions. That is, some policy restricting the amount of pure EPA dietary supplements on the market or the labels of dietary supplements (similar to the 2 recent lawsuits) or the max % amount of EPA in each pill where it crosses over from a DS to a medical product. Well I guess that's my personal hope (could be wrong) and that's why I agree with some others on here that chastising the FDA (BB) about the history of ANCHOR is really not such a bright idea.
One thing nobody has mentioned on here (very surprising) and I think would be a MAJOR positive for shareholders is a V price increase. We all know JT has said its a volume gain, but its obvious we got something good and there is going to be a lot of demand for V over the next few years. The data was so good, so much better than more expensive PCSK9s and I think the pharma-economic studies to come over next few months are going to give Amarin a great opportunity for a nice price increase next year. Supply VS Demand tells me doing this right now is a no-brainer.
ahhhhhh SAM, we all miss you today :)
PS watching week to week scripts is fun but I am only expecting scripts to really take off around Feb/March.
See your point - thanks HDG.
Remind me again your sales est numbers for 2019 onwards (know you had it from a previous post - but forgot the number). How long do you think it takes them to get over $1bn?
yes Raf but my point is:
WHY? What exactly is the blocking IP which keeps Epanova off the market. BB? North? Anyone?
JT in the last call mentioned their IP blocks Epanova but then before he has said that if they succeed it will be a good thing as it would build the entire market class. Which one is it? We want you to succeed to build the market or we want to keep you off the market?
The issue Amarin may have is that Generic Lovaza is that little cockroach in a nuclear war... benefitting from the R-IT effect.
Thanks S! Really V is pushing up sales of the class and this is a big question I have for the board, what is stopping docs from prescribing generic L, even without a CVOT it is well covered and generic and people are very happy to generalise. Annoying!
Also for EPANOVA what happens when strength reads out? Amarin say two things:
1. Competition is good and it will build the class of omega 3s and build the market.
2. We have blocking IP that stops Epanova from coming to market
WHICH ONE IS IT? Can’t be both surely...
Interesting, thanks Tosca. Still need a big long term CVOT...
Hi north, hope all is going well with you.
could you pls post the full article for us non NEJM paying subscribers. :)
All this BO talk can be put to bed if we can all somehow find out if the company has officially hired a bank to work with...This is very hard to know. You could ask the management of the company as a shareholder...but I don't think you would get much traction or a direct answer. If anyone could find this out, that will be your biggest clue. I would bet they are working with a bank right now.
Good to see JT yesterday also agree with this jt...that Lovaza could succeed due to the patients enrolled. However didn't realise they would infringe, most probably would infringe on the label claims about rising LDL so lets wait and see STRENGTH results...
Jt0082 Saturday, 11/17/18 10:27:13 AM
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One thing to note in STRENGTH is they enrolled an even higher risk of patient than REDUCE-IT - in fact, on average if you compare to REDUCE-IT >180mg/dl or something from memory, these stratified patients just showed something like 40% drop in death in R-IT. Bodes well for AZN that they enrolled such high risk group. Although I still think free fatty acid form will cause more GI side effects and enrolment is going to be much more difficult now... but that being said it will likely show some efficacy. Base case is not futility imo.
Man, this post is so on point.
Agreed, this elf is wise.
THE FISH LIVES!
Goaded out of the sea by an ELF. Draw that one :)
Great video thanks. Rings true.
Nissen is not a total quack, he was/is right about lax regulation of devices in EU if you have been following what is going on.
But still believe his Viox crusade where he was right has him on the scale of being overly cautious/pessimistic. This was clear too in the great WIDOWMAKER documentary. One of the questioners brings up a great point too about being overly cautious/pessimistic and harming lives by doing too many studies. Point is totally moot now anyway due to R-IT. I am glad the FDA didn't approve Vascepa first time around, sets up a massive differentiated competitive advantage for AMRN.
Why do people speculate about this money for other uses such as Pharmakon and also that their is a EU deal. Nobody said anything about either.
Its very clear what $ is for and dilution is minimal. This money is mostly for raising marketing profile, adding sales force, filing sNDA and most importantly:
ADDING EPA SUPPLY!
Wouldn't be surprised to see Amarin do something more meaningful to bolster their supply situation. Very important if they plan to be selling billions of V in a few years...
Who are you associated with and employed/paid by?
If I had to guess I would say its AstraZeneca but guess could be many other companies too. Why do you spend so much time here constantly espousing negativity?
I think you will be wrong again... just like your blizzard of 'evidence' that R-IT would fail.
i thought you sold your shares and had stopping posting ? arghhh
Ridiculous assertion. You are very wrong again.
Why wouldn't they:
1. They agreed to the MO placebo in the SPA - remember its THEIR CVOT study more so than Amarin's.
2. The RRR margin is so significant, its practically moot.
3. The FDA will hopefully see that you and others criticising placebo are merely doing it because you and your employer's business is threatened. Hopefully the FDA will ask some tough questions as they should, but will not allow conflicted people with biased agendas on the panel.
Combination with statins is a ‘compliance play’ and while it’s novel and AMRN has the IP, this is about the only time I agree with Phyr’s biased negative agenda: very difficult to do as which statin would you chose and which dose? Too many options. Possible I guess but difficult...
this is great work, thanks circuitcity.
SAM's usual friday post and this chart are going to be the most important/fun things to watch going forward...
Logarithmic chart scale for the rate of growth :)
John J.P. Kastelein (author of the recent NEJM citation - FISHing for the Miracle of Eicosapentaenoic Acid)
30 mins of him discussing lipids in relation to MDGL (Kiwi) AND of course REDUCE-IT:
https://edge.media-server.com/m6/p/ugohg5f8
Starts around 47mins trashes the length of the PCSK9 trials and all about dyslipidemia, calles REDUCE-IT basically a diabetes trial...
John J.P. Kastelein (author of the recent NEJM citation - FISHing for the Miracle of Eicosapentaenoic Acid)
30 mins of him discussing lipids AND of course REDUCE-IT:
https://edge.media-server.com/m6/p/ugohg5f8
"GAME CHANGER" from the president of European Society of Cargiology:
Not true at all BB - Lovaza/Omacor also has an afib warning... and sold $1bn per year WITHOUT any outcomes study...
Nice thanks bfost - by the way one theory is that the slightly higher level (1/100 1%) of afib on treatment arm was the EPA doing its job with some desired flutter prior to stroke.
Ain’t that the truth. Science will continue on of course on EPA but it’s less relevant now for the investment thesis. All about the sales ramp from here on out....
Nice bfost hope you were vocal ;)
One thing to note in STRENGTH is they enrolled an even higher risk of patient than REDUCE-IT - in fact, on average if you compare to REDUCE-IT >180mg/dl or something from memory, these stratified patients just showed something like 40% drop in death in R-IT. Bodes well for AZN that they enrolled such high risk group. Although I still think free fatty acid form will cause more GI side effects and enrolment is going to be much more difficult now... but that being said it will likely show some efficacy. Base case is not futility imo.
THANKS ALL, I must say this board has somehow worked its way into my daily life!
Love all the different characters on here...what they add (or subtract) but JL while you have a point, I wouldn't worry about the stock in time. Short term, yes momentum, leverage, options, and traders are involved so will be volatile, but long term it will be about V scrips and V scrips alone until they reach a trajectory where BP strikes....
Interesting everyone is only now raving on about mineral oil and Nissen..... I wanted to point out my FIRST EVER post in this merry elf invested anonymous playground which got shouted down as me spreading FUD by Raf hahaha lol TOO FUNNY :)
Jt0082 Tuesday, 05/22/18 10:30:30 AM
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Hi All
Really enjoyed some of the comments on here.... Some really good knowledge out there from some very long term users of V, statisticians, physicians, believers in EPA and also believers in REDUCE-IT. Please keep up the great thoughts!
With regard to the stock, sentiment over the past few months seems to be hit by not only the meta-analysis saying 'fish oils' don't work... as well as the fact that their chief legal officer sold his stock in advance of another dilutive capital raising.
The one thing I was curious about was the comments from Dr Nissen (the chief study investigator) from Cleveland Clinic for AstraZeneca (Epanova)going out of his way a few months ago saying he thinks REDUCE-IT should be invalidated due to the placebo being mineral oil instead of corn oil or something of that nature. I did some research online and saw there were some concerns from the FDA debacle about the use of mineral oil as the placebo.. Dr Nissen was saying it cant be effects of V, it has to be because of the Placebo that the results are so good. I am not sure how to take that comment or how much truth there is to that or if this is someone who has an axe to grind cause of AstraZeneca. Maybe some others on this board also knew about this and have any further thoughts around this?
MINERAL OIL was always the biggest risk for me, hence my first post on here, but now having seen the results, imo its definitely not what presents the biggest risk to the investment thesis right now, sorry JL.
ok based on this response now and everything before, I think anonymous fish is right, phyr is for sure associated with AstraZeneca!
Good luck then phyr to you testing yet another incorrect theory of yours about DHA and also recruiting patients in STRENGTH now that REDUCE-IT is out..... no way enrolment/compliance is going to be easy for AstraZenca when Vascepa hits the market.
funny thing is you wont be able to complete your study YET you still think Amarin need another one. almost comical.
Sam thanks as always your dedication is amazing, did you manage to put all your data into chart form?