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A fairly common phrase from the part of Ireland i'm from :)
It was reasoned that there was bugger all point in pursuing it further until amr101 demonstrated safety and efficacy in R-IT first.
Thanks for the reply, much appreciated.
I'm unfamiliar with the territory but what you are saying makes a hell of a lot more sense than a straight up BO offer of $50-100B+ at the current juncture.
$15-20B cash pre the sNDA filing, and then several CVR's seems the way to go - one for the sNDA FDA approval; another for a revenue milestone; further CVR's maybe for additional future indications.
Gonna be an interesting few weeks ahead whatever happens.
There it is there, good article :
https://www.businessinsider.com/lipitor-the-best-selling-drug-in-the-history-of-pharmaceuticals-2011-12
Agreed - in 2 or 3 more years. Not this year or next though. The money they raised recently is nowhere near enough to really tackle a market this size what with the marketing, sales reps, production scale up requirements etc etc. With the cash they have on hand it will be slow and steady for 2019 with $1b+ then in 2020. BP can throw a billion in cash at this immediately.
Anyone ever looked into how much money Pfizer threw at Lipitor in the early days?
I'll try and dig it up now....
Apologies, I missed that post. Thanks for the reply.
Thank for the reply. Completely agreed. Any particular diet that you recommend to patients to help lower their CRP and other markers?
What are your views on hsCRP and it's importance as a predictor of CV disease? What would you consider to be an optimal hsCRP value?
Thanks.
There's no doubt that an acquiring BP would be getting Amarin for a steep discount in the January sales at a price of 40-50, but when you consider that we were trading at $2 and change not so long ago, 40 is far from chump change to me anyway.
Of course you're looking at a share price of 100+ a few years down the line on the GIA path, but I'd personally rather take half that now and double my money elsewhere in a year or less. Each to their own but at the end of the day the only real opinions that matter here are those of the Amarin board and the Baker Bros.
How much money do the BBs stand to net with a $45 BO? And Thero and Co?
Thanks for the post.
How much do you think Amarin is currently worth and what do you think an acquiring company would be prepared to pay for a BO?
I had a look at the TSRO charts...
At the time it first spiked up on BO rumors its average daily trading volume was around 2 million. Amarin's is currently around 8 million, so that accounts for the larger volume observed in AMRN yesterday.
TSRO's up move was held up at its 50day MA whereas AMRN blew past it's 50day MA yesterday. It was two weeks then before TSRO made it up to its resistance before the BO offer came in. In Amarin's case the resistance is in the low 23's, so im looking for a run-up to there within the next couple of weeks if these BO rumors are to be proved legitimate. The share price seemed to be in a hurry yesterday - shorts covering and bulls climbing in to ride the wave.
Once we're in the 23's we will then see an offer in the 40s IMO.
Why should Amarin sell the company? The main reason I believe is because BP have the resources to enable them to get this drug to the masses far quicker than Amarin can.
Nice move again yesterday but the drop back down to the support at 15 on high volume has me cautious. If it was big buying rather than selling during the close, then the share price should have no problem flying out of the traps today to close higher again. Looks to me like shorts were scrambling for cover.
Not quite yet, no :D At the current price levels her demands are ridiculous. Ideally, i'd sell half if it hit the 40s, and then i'd let the remainder run to whatever.
I'm not convinced we see the 40s any time soon though on the GIA route, but I could be very wrong. News of spectacular earnings beats, priority FDA review, a European partnership etc may all be enough to keep the share price rising absent of billion $+ sales. Sarepta have had very similar sales to Vascepa yet they have commanded a multi-billion $ market cap for well over a year now without Wall St batting an eye lid.
At what point does Wall St say 'show me the money'? The whole thing seems so arbitrary, no rhyme or reason to it. Seems to boil down to favortism more than anything.
Good to see Feuerstein and co now silent on the mineral oil non-issue. That whole charade looks to me like it was a well orchestrated smash and grab to enable hedge funds to profit from shorting the stock, and then enabling them to buy common stock on the cheap between 11 and 15. The 10k's for Q4 2018 will tell a tale.
Thanks North. I listened to the JPM conference call. For 2019 earnings you're looking at 500M bare minimum IMO without the expanded label and up to around 750M, and you could argue earnings will be closer to a billion if they get FDA approval around November.
Thanks Sonam.
A fairly bland offering from Feuerstein.
A smart move by Thero to lowball the 2019 earnings projections. The $350M is what you would expect conservatively based on previous growth and with the same number of sales reps. But with the number of sales reps now more than doubled, and armed with the R-IT data as published in the prestigious NEJM and targeting cardiologists, it's very difficult to imagine Amarin not blowing that 350M estimate out of the water. That obviously then bodes very well for the share price each time the 2019 quarterly reports roll round, and Amarin spectacularly smashes past it's earnings forecasts each and every quarter.
Can someone who is a STAT member post the content of Feuerstein's JPM Amarin article? Thanks.
Yes, absolutely you could. Would be an excellent way to halt a rally and ensure your options remain in the money wouldn't you agree? Also allows you to accumulate cheaper common stock.
Your ignorance of TA getting the better of you is it? Feeling out of the loop? You prefer cartoons of donkeys showing their ass and erupting volcanoes do you?
Define "useful" for me. GIA share price projections and exhaustive chat related to Vascepas well established efficacy and safety - is that what tickles your pickle?
You don't own this message board. I'll continue to post whatever I want, however I want, and whether you like it or not.
Enjoy your day.
A nice move up yesterday but failed to overcome the resistance on the daily at 14.14. If this bull move is to continue it needs to bulldoze through yesterday's high without looking back to close the day in the high 14s or 15s. Anything less than that and it's headed back down to the 12s IMO.
Yes 350M may be a conservative projection for public consumption, and yes it may turn out that they pull in 500M in 2019. Hell, let's go all out and say they pull in 1B. Even at 1B in sales there is no way the market cap is going to the dizzying heights of $50-100/share that were bandied around pre and post R-IT results. $50 puts the market cap over $15B. With 500m or even 1B in sales in 2019, and no official FDA approval likely until end of Q4 2019, how is the company gonna command a $10B+ market cap? On hopes and dreams?
I'm personally hoping the price climbs back up to the 20s over the next few weeks and then they get a BO offer in the 40s and that's me happy. If there's no BO offer over the coming weeks I'm bailing and will look to get back in further on down the line. I don't see any point holding the stock for a year while it more than likely trades sideways and/or down for the vast majority of it. The odds of it trading over 20 six months from now are slim and none IMO.
Been holding the stock for years, can't remember how long. 8 years or something like that. I want a divorce :)
Cheers for the reply. No worries, I'll have a listen to the JPM call and maybe they will update guidance at that.
The FUD is all part of the game. I'd be more worried owning a stock that only had fanfare. The FUD is especially welcome in a stock like this that is trading at such a low price which such huge upside potential. Tells me the pros are active and busy greedily accumulating common stock.
I see the price getting taken down towards 1.50 over the next few weeks and then February should see the start of the run-up into the results.
Thanks for the link. Any updated recent guidance as to when the RSV Ph3 data is to be announced in Q1? Are we talking more than likely in March?
The 2019 outlook is extremely prudent IMO, and a reality check for the 'go-it-alone' brigade. One way or the other that go-it-alone bubble will be well and truly burst in 2019 with news of a BO, or with far more modest quarterly earnings than most of the brigade anticipated.
I'd say it's a very rare occurrence. Most companies are gonna have a very good idea whether or not their trial data qualifies the drug in question. Even if you are not 100% certain surely you would chance your arm and apply for priority review regardless. No doubt the fee for priority review is significantly higher than the standard fee though, so maybe that's a hindrance. Time is money and all that.
Priority review will be decided by the FDA whether Amarin requests it or not:
"FDA determines whether an application qualifies for priority review (versus standard review) for every application, not just when priority review is requested by the applicant."
Thanks for the link.
"This is a very big deal because if Vascepa gets the PR designation it cuts the the FDA review time down from ten months to 60 days or less.."
My understanding from reading the document is that the FDA will take 60 days to decide whether or not to designate a priority review, and then:
"A priority review designation means FDA’s goal is to take action on the marketing application within 6 months of receipt (compared with 10 months under standard review)."
So if the sNDA is submitted mid March the decision to prioritize the review will made be by mid May, and the final decision on the sNDA will take another 6 months ie mid November.
No, its the daily price action from 9:30 to 16:00 that matters. The fact that the after hours volume is >1M simply tells me that we're in for an action packed Monday.
"Short term, there is a nasty little gap between 12.41 and 12.43 which needs filling. My guess is that the price will be whipped down this week to fill that gap and to shake any remaining weak hands out of their positions. Once that gap below is filled the price is then free to climb."
The stock price only fell to 12.44 so the gap has yet to be filled. There is now another gap between 12.61 and 12.77 so it's highly probable that prices are marked down early next week to fill those gaps. It wouldn't surprise me to see the 12.00 stop losses taken out. By the end of the week the price should have recovered to close in the 14's or even higher.
All just my opinion. Take it or leave it.
"No clue what you're talking about. All I said is that the scenario that you gave (submit sNDA in March) is highly improbable"
Highly improbable you protested.
From the recent PR:
"Additionally, the list of prespecified endpoints which the company intends to evaluate in support of the sNDA is extensive. As a result, submission of the sNDA is not anticipated until late in Q1 2019."
https://ih.advfn.com/stock-market/NASDAQ/amarin-AMRN/stock-news/78995812/amarin-provides-preliminary-2018-results-and-2019
My interpretation of "late in Q1 2019" is some time in March. So, what happened Raf?
You left out the last part of my post:
"My guess is that the 13.00 stop losses get taken out next week and we close the year above 13.56, but not by much."
Indeed the 13.00 stop losses were taken out, and the 12.00 stop losses for good measure which I didn't see coming.
The close above 13.56 is bullish and tells me that the gap between 18.13 and 19.39 will be filled over the coming weeks.
Short term, there is a nasty little gap between 12.41 and 12.43 which needs filling. My guess is that the price will be whipped down this week to fill that gap and to shake any remaining weak hands out of their positions. Once that gap below is filled the price is then free to climb.
Take it or leave it. I'm long the stock and the above is my own personal interpretation of what the TA is telling me.
You are basically asking me to explain to you how the stock market works, and at the same time you are getting testy with me. Go figure it out yourself.
What do you mean who needs them? Why buy millions of shares in the 20s when you can buy them at 13,14,15,16? If I told you that the share price was going to be 40 a few months from now, would you rather buy 5 million shares at 23 or at an average of 14? You think these multi-billion and trillion dollar hedge funds are stupid and got to be worth what they are by being stupid? Shares in the mid to low teens are far better value when you are buying than the same shares priced in the mid to low 20s. Simple as that.
The 13k's for the Q4 period are going to be very very interesting reading.
The support remains at precisely 13.56 on the monthly charts. The fact it has fallen below that level on both the daily and weekly time-frames is bearish on those time-frames.
A closing price level or above 13.56 yesterday would have been bullish going into next week, but the close below at 13.23 now brings the 13.00 stop losses and high 12's very much into play next week.
If it closes end of the month below 13.56 the bear triad is complete for me on the daily, weekly and monthly time-frames, and I'll be running for the hills on any decent rebound back up over 15 in January . But as long as it closes level or above 13.56 end of December I see the gap between 18-19 getting filled, with the bull move up continuing to the 23's.
My guess is that the 13.00 stop losses get taken out next week and we close the year above 13.56, but not by much.
Yeah I try and stay away from making daily price predictions because I find the weekly charts much easier to read, but i've been warning about the possibility of the 13's for several weeks so no surprise to see it finally hit. Was too much volume down at that price level last time round which meant it needed to be retested to shake out any remaining weak retail hands before it could move back up. Those weak hands need to be removed because they are liable to sell once it hits the 20s again, and selling is obviously bad for higher prices as it holds the whole show up.
Far less volume on the move down to the 13's this time round which tells me the selling is done and the pros have gotten what they came for - bargain basement great value common stock prices.
The support is at 13.56 so you want a close today level or above that if you're long the stock. If it closes in the 14s it would be very bullish for next week IMO.
Premarket price moves are rarely backed by substantial volume so it's a waste of time taking any interest in them IMO. Invariably a load of churn in the price action for the first 15-30 minutes so I rarely bother to look at the share price until at least 30 minutes in, or better still an hour in, once theres been a chance for some volume. That gives you a decent idea then how the days trading will likely pan out.
Well the good news is that the selling is almost done now, and once it is the price will start to rise sharply IMO. I own shares and haven't been trading the down move, just calling it as I see it based on my interpretation of the charts. I don't do fanfare and I don't do emotion when it comes to my analysis. I just say what I see.
There is still the possibility we see high 13s today very briefly. The odds are slim though unless it opens with a gap down. Retail traders like putting stop losses at whole numbers so they may whip it down and take out the 14.00 stop losses. If it does then it should happen early morning and then that's the end of the downside.
No worries.
Gets you thinking about STRENGTH and AZN's use of corn oil as their placebo.
The paper mentions: "Dietary LA (linoleic acid/omega-6) can decrease conversion of dietary ALA to tissue EPA and can decrease tissue levels of EPA and DHA. LA is a precursor of AA (C20:4n-6), which is a metabolic antagonist of EPA".
It also mentions "Sunflower, peanut, soybean and cottonseed oil" as being high in LA.
Sunflower oil has 66% LA;
Peanut oil has 31%;
Soybean oil has 51%;
Cottonseed oil has 54%;
Corn oil is not mentioned in the paper but it has 58% LA! Not something you would want to be taking 4g/day of i'd say. And i'd also say Dr Nissen and AZN know it full well too as they switched their placebo from olive oil to corn oil for the STRENGTH trial. Olive oil has only 10% LA.
Very very sneaky indeed, and funny that it's the AZN doc's who are the ones who have issues with the R-IT mineral oil placebo. How can anyone argue that AZN were not trying to rig the STRENGTH trial by switching their placebo to a known pro-inflammatory n-6 corn oil? It's a joke.
"AF is showing his true colors. may be he is very nervous today."
True colors? Nervous?
2 weeks since I made the prediction so lets re-visit it.....
"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."
Correct.
"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?"
The S&P500 did indeed fill that gap and sits currently at 260.47. As it fell, so too did Amarin, into the $16's as predicted.
I concluded the post with:
"It wouldn't surprise me to see prices in the $15's or even $14's within the next couple of weeks."
The lowest it went was 16.00. Still has further downside next week IMO, certainly into the $15's and will more than likely hit the 14's. Not so sure about the $13's but could easily dip its toes there briefly too. By the end of the week prices should have recovered to the upside, somewhere between 16 and 17 is my guess. Should be a very lively week with far more volume than last week anyway.
The S&P500 now has 2 gaps to fill on the upside so one final mark down next week and that's the October/Nov/Dec bear move done then IMO, as it then starts trending back up to fill those gaps. Amarin will start trending up with it too to fill its own gap.
A decent paper here with the skinny on fish oils:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1526555/
"4) I personally think O-3s DS are legal. I view them as an entirely different part of the market. Maybe they don't provide much by way of huge benefits - but neither does drinking Coke or eating a Big Mac. That doesn't make them illegal."
They are of course legal, but what use do people have for continuing to take them with vastly superior Rx grade EPA and high concentration EPA + DHA preparations also on the market? Fish oil supplements are not regulated and you cannot guarantee uniformity of content between batches of pills. A typical 1g fish oil supplement will contain a mere 18% EPA 12% DHA, and the remaining 70% is gunk containing significant amounts of saturated fats and oxidation products. Vascepa is pure EPA without the gunk. A nice paper here re Vascepa/Epadel/Jelis etc:
https://lipidworld.biomedcentral.com/articles/10.1186/s12944-017-0415-8
Compare that to Epanova which is 55% EPA 20% DHA 25% gunk.
Why do patients take fish oil in the first place? To reduce inflammation and for 'heart health' primarily. There is some scientific literature suggesting modest benefit.
So why don't the FDA act now? What's the hold up?
The hold up is STRENGTH IMO, with the FDA playing a lets wait and see game.
If STRENGTH is halted for futility its goodnight generic Lovaza, Epanova, and all other OTC and fish oil supplements. The FDA will come down hard on all of them, and all the spoils will go to Vascepa as it will prove that it isn't the 4g dose and DHA, it's the EPA.
If STRENGTH shows a very modest benefit in RRR in the 5-10% range, this would suggest that EPA+DHA formulations do have limited benefit but nothing close to Vascepa. Vascepa wins again in this scenario ultimately because it suggests that it is the EPA that is responsible for the vast majority of the benefit, as R-IT's RRR was 25%. You can also then extrapolate the data out to encompass all OTC and fish oil supplements containing low amounts of EPA+DHA, and it will then be goodnight for fish oil products with EPA+DHA concentrations less than that of Epanova (which is just about all of them).
If STRENGTH somehow shows a 15-25% benefit then it would suggest that the dose IS important, and that EPA+DHA preparations DO have clinical benefit. You could then also say that fish oil supplements theoretically have some modest benefit too, but you couldn't make any claims on your label. This is obviously the worst case scenario for Vascepa as pure EPA will be downgraded, and DHA upgraded. Epanova will then provide legitimate competition to Vascepa but all the OTC and fish oil supplements will also claim market share purely because they are cheaper and easier to purchase. In fact sales of fish oil supplements may increase significantly because customers will know that the dose of EPA is all important.
4g of Epanova has 2200mgs of EPA. Vascepa around 3800mgs EPA/4g. So you would be looking to get around 2000mgs (2g) EPA/day from your fish oil supplements. A 220mg EPA/g preparation will get you there with 8-10 pills/day. Sure you will have the fishy burps and the product is unregulated, but you may be potentially reducing your RRR by around 20%, and you will be doing it conveniently and on the cheap, so who cares?
This company sells 22%EPA + 15%DHA fish oil pills for £0.17/capsule:
https://www.hollandandbarrett.com/shop/product/holland-barrett-omega-3-fish-oil-capsules-1200mg-60019042?skuid=019042
At 8-10 pills/day you are looking at a daily cost of only £1.36-1.70 (around $1.70-2.15). This is a mere $12/week, $50/month, and $600/year. If you have no insurance and a modest income why pay $200+/month for Vascepa or Epanova? The average punter couldn't care less about 'purity' and all the rest. Cost is by far the primary consideration.
So there is a lot more riding on this STRENGTH trial than many people appreciate IMO. I know i'm getting way ahead of myself and that the chances of STRENGTH succeeding to any great degree are very slim (and even if it does there's still the potentially huge LDL-C raising elephant in the room), but the point is that you cannot put the nails into the Epanova/OTC/fish oil coffins until the results of that trial are known.