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Carry on, you know best.
I just go with what the chart says and it says there's a gap down to 16.91. I aint whipping these numbers out of the air. 18.00 is the 200MA and there's a strong possibility that's as low as she goes (if it even goes lower at all; my analysis and interpretation of what im seeing could be way off; i doubt it though). From what I see 18.00 is highly probable (id go with >75% probable) and for 16.91 id put the chances at around 50%.
The probability of the prices continuing on up higher from here until Christmas id put at <5%. Just my interpreation. Im not always right. Its impossible to be. The very best traders on Wall St are only correct around 60% of the time, but they are experts at spreading risk and diversifying their portfolios.
How many of you reading this have 100% of your chips stacked on Amarin? Or 50%? I wont go over 10% on any position these days. Less upside yes, but far less downside too. So if the sht hits and a stock drops 50% in one day you only lose 5% of your total portfolio value and you live to fight another day. All depends on your tolerance for risk and how much money you are prepared to lose ultimately. Most retail traders have a very high tolerance for risk and will continue to have until they get badly burned a few times. Each to their own.
Im just more cautious. I've found it to work better for me over the years. The LOD to HOD has come back to bite me in the ass several times before. The close to LOD rarely ever does. Cheers!
Cheers for the post. True, but im wary about those partial gap fills because ive been burned with them before. You could very well be right though because of the 200MA price point. I think 50% purchased at 17.90 and then a bid at 16.90 for the other 50% is how ill play it. If it bounces hard off the 18 and I dont get the chance to then so be it.
If you look at the chart you will see that the lower gap hopped over the 200MA. The 200MA is a significant point of resistance to higher prices usually and one that any retail stock trader will be familiar with. So to avoid that wall of selling you simple gap the price up and over it which the market makers did.
There's nothing that says that the lower gap "will" 100% guaranteed be filled. It's all a game of probability and my interpretation of what I see in the chart (based on logic, intelligence, perception and reason predominantly) tells me that it will more than likely be filled.
The only slight doubt I have about it not being filled is because the 200MA line is now acting as support when approached from above, so a wave of buying is likely to happen if/when it hits it. The shorts will have to slam the bid hard if they want it to breach that level and that costs money. But considering that the FDA are likely to approve the label in some form, it is probably cost effective for them to do it, and then buy in the 16's and 17's because they know there's a very high probability the share price will be north of $30 soon enough. It's all a game.
SonamK, thanks for the message, nice to hear from you again!
Here's my TA interpretation for AMRN based on a daily price chart.
I'm very wary of those two gaps. The one below is to 16.91 between bars 1-2. I know that there is strength in the background but I also know that there is weakness so something has to give. Because of the no demand for higher prices on bars 8 and 9 I see prices going lower. The 200MA is around 18.00 so prices should go at least as low as that. 18.00 isn't too far off 16.91 so I can easily see them slamming the price down to the high 16's to fill the lower gap. This serves the dual purpose of catching out anyone with tight stops and also any weak holders who bought in the 20's on the run-up to the ADCOM. Some analyst/'journalist' will likely release some garbage price estimate or uber bear thesis and they will slam rices down on the back of that. It should be a wide spread down day to panic people and prices should recover then to close the day back in the 17's. Prices will bounce around a range in the 17-19 area for a while then before they take it back up in mid-December to close the other gap above up to to 22.73 between bars 6-7.
All that volume up around 23-25 has created big resistance to higher prices so I dont see prices going higher than around 23-24 pre the FDA label announcement. Once announced and if positive, prices can then be marked up and over the resistance. The marketmakers know exactly where the resistance levels are, and so do I. A 50% mark up takes you into the 30s which is the perfect price range for a BO offer in the 40-50s wouldnt you agree?
I could be wrong of course and the prices could be marked up sharply to close the gap above at 22.73 next week, but if they do that the up move will be very short-lived because weak holders and tight stops still need to be wiped out below.
So take your pick but one way or another i predict much lower prices in the near future before a recovery. My buy order will be ready and waiting at 16.90.
All of this is my own interpretation. Im just a dude with a laptop trading for himself. I dont work for anyone. Take it or leave it.
I dont know. My guess is $20B+ but you cant make any accurate peak sales estimates until you see what label they get. The BO price would be around 3x peak sales with CVRs
Yep. One other point of debate is the age. I think the study was 45 and older but one of the panel members asked the FDA to consider lowering it for insurance coverage purposes I think it was. Logic and common sense would tell you that the age should be 35+ or 40+ but again, the study data wasnt obtained from those age groups so will the FDA lower it without having data? Im not sure that they will.
I think they get a BO offer and the company is sold in 2020.
If they go it alone then revenues in 2020 would be $1B and change.
No idea what peak revenues for the drug will ultimately be but I am certain that if they get a decent label it will become one of the best selling drugs of all time. Drugs like this come around once in a blue moon.
Still one big hurdle to overcome first though.....
Would be a nice gesture from the FDA to announce approval of the label before December 25th. This is a heart drug after all.
Big time. But something tells me that JT may not be as loose with his lips about GIA/BO talk as the last CEO JZ was :)
Agreed. Thanks for the reply.
So do you think they will be able to sustain a market cap valuation of $8B in 2020 or do you see a big sell off?
It doesnt seem to me to be a good stock to sell/short because a concrete BO bid could be tabled at any time in 2020. Yes the valuation is currently excessive, but NOT if they receive a BO offer it isnt because an offer would be a multiple of the current market cap. Seems to me to be a hold and add on any weakness kind of a deal.
That BO offer 'threat' scenario really limits any significant downside IMO and any real future downside only comes if/when Amarin refuse any BO offers and make it very clear that they are going it alone.
Surely you have to go with the scientific evidence? Thats what the FDA are all about. The primary prevention cohort suggests benefit but doesnt scream it the way the secondary prevention cohort does. The numbers are close but there not quite there for primary. The data isnt quite robust enough for the size of the patient population at risk. Thats just my opinion of how the FDA may be thinking based on what the panel members said.
My own personal views are that they should grant primary because the drug works and its extremely safe. I dont believe that it causes any bleeding whatsoever and the significant side effects are caused by other unknown factors related to the patients diet and lifestyle. I bleieve Vascepa can ONLY benefit these patients. Approve the expanded label and let the docs decide when and where it is appropriate to use ie most cases. I just dont believe thats what the FDA will do though.
Nice post, thanks.
"IMO they are on pace for 2.5-3 billion in 2021"
What would you predict for 2020? Its gotta be under $2B no?
Yeah I was way off with that one. I had that 200M number in my head from 2018 revenues. So what are they gonna pull in this year, ~$500M? Thats a long way off $8B. Its one thing having an expanded label and another thing realizing that potential profit. What will the 2020 revenue estimates be with an expanded secondary prevention label? $1B? $2B? It wont be $8B IMO.
Thanks for the advice and for sharing your opinion :)
Im probably very conservative and your maybe slightly on the optimistic side so lets meet in the middle and we'll probably be accurate enough :)
The whole Secondary prevention patient pop will be less than 10M and there's no way you're going to get 100% market penetration so i'd go with 5M personally which is around $8 billion / annum peak in the U.S alone - which is exactly what the market cap stands at today 'coincidently'.
So you're looking at a buyout valuation of what, $20B plus? Roughly somewhere around $45+ /share?
If they dont get an offer/accept an offer, and decide to continue to go this alone, mark my words there will come a time when Wall St slashes the $8B market cap and says show me the money. What are annual sales at now? ~$200M? Thats a long long way off $8B. You could very easily argue that a valuation of $2B is far more appropriate which would put the share price around $5.
How do I feel about it? I cant say that I register much of any emotion when I think about it. I dont believe that the placebo had/has much if any effect at all on statin absorption, I never did. I'd put its theoretically negative effects at <1%. What I believe and what Amarin bulls/bears believe isnt important though, its what the ADCOM panel and most importantly what the FDA believes that matters.
Personally id like to see how the EVAPORATE results progress each year over 5 years vs placebo. The study will show efficacy but its too short for my liking.
I hope they get but seriously doubt that they will. For the size of the patient population involved in the U.S and worldwide I think that the FDA are going to err on the side of caution because the primary prevention patient population only represented 30% of the trial. I think the FDA will want something more along the lines of an 8000-12,000 outcomes study for primary prevention. Amarin are just chancing their arm really.
Here's the archived webcast of the ADCOM if anyone is interested:
https://www.fda.gov/media/132476/download
My connection was garbage last week so only got round to listening to it properly today.
Multiple panel members have issues with the mineral oil and statin absorption thing and a pharmacokinetic study was suggested by the chair as it would be "relatively easy to perform" as "we are not looking for endpoints, we are looking for absorption, ehm pharmacokinetics".
The discussion then got a bit muddy as they couldnt determine when exactly the placebo and statin were administered during the trial - before food, after food, what time of day etc? The chair then asked Amarin to get back to them to clarify but I dont think that they did.
Its one thing performing a pharmacokinetic study on a mineral oil placebo and a statin on an empty stomach and another thing entirely to perform an analysis with a belly fully of food and a statin and a mineral oil placebo. The results will not be consistent so I think its very unlikely that the FDA will request it.
During the discussion before the vote and after the vote the subject was not brought up again by anyone which suggests to me that they are going to let the placebo/inertness statin absorption issue slide and defer to the existing science which suggests that any potential mineral oil statin absorption issue could only account for about 3% of the total efficacy. Good news for Amarin obviously because if the requested that study and issued a CRL telling Amarin to resubmit the sNDA once they have it, it would set back approval by about a year.
Also seems very clear from listening to the ADCOM that Amarin havent a prayer of getting the Primary indication label but that the Secondary prevention label is pretty much guaranteed. If they want Primary they will have to conduct a whole new trial with a different placebo.
The label they will approved for will be for patients on statins LDL-C between 40 and 100 with established CVD, with TG's >150mgs/dL,and aged greater than or equal to 45 years old.
Anyone know what is the patient population in the U.S for the secondary prevention indication? I think I remember seeing it on an investor presentation a few years ago but its been removed now. Was it estimated to be ~35 million?
Messy looking TA chart with a major battle going on between the bears and bulls the past few days. There's big big players involved that clearly disagree on what the value of Amarin is worth upon an expanded secondary prevention label. I'll post a chart once the volume settles down a bit.
Gap at $18? What gap is that exactly?
On the daily chart there are two gaps - one down to 21.49 - which was filled today obviously, and another one down to 16.91.
And thats what im concerned about given the uncertainty, and considering the huge size of the patient population intended to treat here. The FDA is all about evidence based medicine and they may require further evidence.
"May require". I dont know if they will require it but I know that the thought was/is in the FDA chairs head at the ADCOM.
Kenneth D. Burman, MD is his name. Im almost certain he was the chair at the ANCHOR ADCOM.
Valeant Pharmaceuticals International (VRX)
ezogabine, partial-onset seizures
ADCOM 8/25/10
13-0 in favor of the drug’s efficacy
CRL (12/1/10)
I have held shares continuously for over a decade. Keep trawling through my posts and you'll find a share certificate from Davys that I posted a while back. I sold a bunch in the high 17's but not all and was hoping to get back in on a dip to the the 12s but it only went as low as 13.76 so I didnt get the chance. I offloaded a bunch on Friday. Will consider getting back in if the gap down to 16.91 is filled.
Those who think im Pyr are off their rocker. I was one of the few who bothered to debate him about the mineral oil after the AHA presentation.
At the end of the day there is no study that has ever been conducted that proves that mineral oil does not affect statin absorption to any significant degree. The FDA scientists have theories but no proof. If they want proof they can very easily ask the sponsor for it. If you dont believe that then dont believe it.
Ever hear of a company called Dendreon? They got a 13-4 vote in favor of approval at their ADCOM and got a CRL soon after. Do you want to know what happened to the stock price? It went from $25 after the ADCOM vote to $5 soon after the CRL.
Dont believe me?
https://seekingalpha.com/article/251267-warning-biotech-investors-fda-advisory-panels-no-means-no-yes-means-maybe
The FDA chair at the meeting asked the asian FDA scientist guy about how easy would it be to conduct a pharmacokinetic type study between the mineral oil placebo and vascepa. His reply was off mic and the subject was changed right after his reply. I dont like that the FDA chair even asked the question because it tells me that he considered it relevant enough to ask the scientist about it. Im looking for an archive of the ADCOM to re-listen to that part but I cant find it.
Zero percent? I'd say its higher than 0% personally but I dont know how high. I notice Feuerstein is still banging the mineral oil drum even today and there has been massive volume spikes the last few days but very little price movement to the upside which tells me that there's a lot of selling going on, and I want to know why and need to entertain any and all bear thesis. Say what you want about Feuerstein, he has connections in very high places.
Am I new to the stock? No. I've held it for over ten years and through the last ADCOM and the last CRL. Are you new to the stock yourself?
What are the chances of the FDA issuing a CRL requesting that Amarin conduct a pharmacokinetic type study to observe the effects of the mineral oil placebo on statin absorption before resubmitting the NDA? And if they did that, and it delayed approval, would it not be very convenient for AZN while they await the results of their outcome study, and also the FDA who would then have two sets of outcome data from the same class of drug to compare?
Anyone else notice the two gaps down to 21.49 and 16.91? Hmmmmmmmm.
Does anyone know where to find an archived recording of last weeks ADCOM?
Thanks
Reminds me of a pack of starving hyenas that just made a kill.
Mercator, Thanks for the reply and the trading advice. I decided to re-enter yesterday with a 25% position at $22 on the back of it. It makes sense to have a small position as insurance against being wrong. I still say that the chances of a BO are small near term, and that the share price is over-heated along with the major indexes and due a hair-cut, but the fact remains that we may see a BO offer on Monday morning followed by a bidding war. Nobody really knows.
This stock could easily be the next Sarepta (SRPT) which has had an unbelievable run the past 3 years and perfectly illustrates your point about letting a winner run.
"AF, it sounds like you suffer from PTSD."
Hahaha - nail on the head. The last ADCOM was a complete horror show. I was all in having watched it fall from the 19's to around 7 and was expecting a positive vote and a swing back up. It went to under $1 instead. I averaged down to about $3 and went all in again in the run-up to the R-IT results. Sold about half then in the high $17's and planned to use the cash to trade around the core but my interpretation of the TA suggested that there was a very high chance it would drop back down to the low teens at least so sold the rest.
After being through all that "anxiety to be right" doesn't bother me. I still say it drops back down near term along with the main indexes but don't have any problem buying back in the $20s IF it closes above $23 and holds the gains. I have it on good authority that the best traders on Wall St are correct only 60% of the time. The main difference between them and retail traders, as im sure you well know, is that they know how to manage risk and when to cut their losses on losing trades. Someone on here had mentioned a company called Novavax a few weeks ago and I saw that the share price cratered yesterday on a failed Ph3 trial. The 13k's for Q4 2018 show that Blackrock held 32M shares, Vanguard 21M, and State Street nearly 15M. Blackrock's fund value is nearly $2 Trillion, Vanguard's is just over $2 Trillion,and State Street $1 Trillion. The Baker Bros are not immune to getting it wrong from time to time either.
I agree with your sentiments re an ADCOM but my PTSD wont allow be to go all in this time round. No reason whatsoever why it shouldnt be a landslide vote in favour of approval because a) The drug works and b) It's safe. You can never be 100% certain though.
Any thoughts on Amarin's valuation? Do you see the share price continuing to rise from now until an ADCOM assuming there is no BO offer? I dont personally but as I mentioned, if it breaks $23 and holds ill have to concede that it more than likely will continue to rise.
What's a boiler room shill?
Will you? Good lad. And what happened to El Chapo and all his powder?
Keep watching, it'll get there. And when it does I will have plenty of dry powder to consider buying back in. Will you?
Not picking up on any negative vibes after listening to the Leerink conference call. The lady interviewing JT was well versed and respectful and the pair of them laughed together twice towards the end of the interview.
JT answered the Q's very well, particularly the placebo question.
He said that the sNDA was almost ready for submission and that they were "planning for an ADCOM". I fully expect one too because of the sheer size of the patient population involved.
That will be the mother of all biotech binary events if it happens. A positive vote at that and shareholders are officially off to the promised land. I also fully expect an AZN rep to be on the panel in the same mould as Dr. Hyatt (he had ties with AZN), pushing hard with the placebo inertness angle and trying to influence the other panel members to vote negatively so that approval is stalled until AZN announce their outcomes data. This indication is big business and I fully expect AZN to continue to play dirty.
Who's gonna have the balls to hold all their shares going into another ADCOM of that magnitude?
But are you factoring in the 60 days review time? ie 2 months plus 6 months = 8 months. You seem to be saying that the 60 days review period is included in the 6 months total period ie 2 + 4 = 6. That's not my understanding of the language used on the FDA website.
I am here because there are considerations beyond a purely long/bullish perspective worth highlighting, and im gonna highlight them for anyone interested.
I read the same bullish/long myopic pumping on these message boards after the ANCHOR trial results came out with everyone bandying around pie in the sky multi billion $$$ revenue projections, and how a BO was imminent. I fell for the hype and held half my shares. The share price then dropped from 19.87 to 0.78. I haven't forgotten about it.
While I dont see the share price dropping to anywhere near that level in 2019, I do believe that there is a high probability that the share price experiences a significant hair-cut from its current price level. I will look to re-enter around $12 as that is where I believe the floor has been set. A lot of cock sure members on this message board think that its nothing but a BO and blue skies ahead, so lets see what happens.
Thanks.
My understanding is that the priority review takes 6 months:
"A Priority Review designation means FDA’s goal is to take action on an application within 6 months (compared to 10 months under standard review)."
https://www.fda.gov/ForPatients/Approvals/Fast/ucm405405.htm
So lets say the sNDA is submitted mid March. The FDA then have 60 days to decide if its priority review or not which would put the decision around mid May. If it's 6 months then that would mean a decision then by mid-November. If it's standard then that would mean a decision by mid-March 2020.
Of course they are going to seek priority review, its worth a lot of money. I don't personally see any reason why they wont get it.
I agree. The point is that priority review is not a guaranteed lock and therefore neither is approval in late 2019. Plenty of folk on this board seem to believe that sNDA approval is all but guaranteed in 2019. It is not.
"Try to think more about peak sales world wide, work out a reasonable multiple of that and have regard to the opportunity Vascepa presents worldwide because that's what seasoned BP executives will be doing with models and comparables to hand."
Worldwide sales and the drug has yet to even be approved for the R-IT indication the U.S? I'll leave the world wide peak sales stuff in the realm of hopes/dreams/fantasy for the time being until the FDA actually approves the R-IT sNDA first. You can do what you will.
"But then again if you want to pedal a negative agenda for your own trading ends go right ahead I think this MB sees right through you."
I think the vast majority of this board own the stock and have an obvious bias towards a higher stock price. They only hear what they want to hear and disregard all the rest. Cognitive bias. Look it up.
"Negative agenda" for my own trading purposes? As previously stated, I do not short stocks. IMO shorting stocks is a mugs game. I buy stock when I consider it cheap/good value and I sell it when I consider it expensive/over-valued. I sold all my Amarin holdings very recently because I consider the stock to be now overvalued. I am am fully aware of its future upside potential and will be watching it closely looking to re-enter at a price that I deem to be cheap/good value. In the meantime I will use the cash from the proceeds of my sale to invest elsewhere in companies that I believe to be cheap/good value. I have identified several that offer far greater upside potential IMO than Amarin does between now and the FDA's sNDA decision.
Is that ok with you?