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Interesting that Prior Pre-clearances are suspended, more often than not you can still sell if it is part of the pre-defined selling program.
If true I really will miss seeing insider selling every first of the month.....NOT!
K thx for DD, wasn’t too hyped by blackout anyway as BO would not have blackout like that and BO is only news that matters until Adcom or approval
Friday is past 74 day letter, makes no sense for that, why would Amarin have more closed periods for ALL employees, closed periods can be for just management, what were previous closed periods, do you have a list and reasons for?
What’s quite often? Blackouts only occur when there is news known to insiders. Few days before an announcement, earnings for example. If there is a blackout then there is news pending of some sort. I don’t know of a scenario where there is just random blackouts just because. The whole point of blackouts is to prevent insider trading on info not publicly available. Could be something not that meaningful, of course, but not sure what quite often means since they probably do it quarterly. If anything meaningful to it you’ll know Monday.
I don’t get the relation between short interest, if short interest increased and it relates to blackout period then you’re indicating bad news is coming?
How would you have recent short interest info? That number just continues recent trend, not any increase in trend so why does that have some meaning?
And what do options got to do with anything, overall there is more open interest in June Than In July?
This seems like a post that has some new information about a black out. But I suggest it should require a little more explanation and details
Not many options expiring today, next week a lot more calls at 18 and above than Puts. Always hard to tell what MM inventory is and what algorithms are driving stock movement. For today nothing about option interest should effect the stock price.
If options mean anything it would stay below 18 by next Friday and be between 18 and 19 by July monthly option expiry. Option effect on SP is overrated however.
It's amazing how it has basically pinned around the $18 number since they raised money at $18.
Comparing to last year same week we had
5% increase over previous ATH
7.72% increase week over week
So 6.6 vs 5 and 12.75 vs 7.72 comparing same weeks YOY and starting at much higher #'s. Overall all good news.
The week that followed was up fractionally (0.64%) so interesting to see if next week sees a better follow through this year.
By far the biggest reason FDA Priority was huge, End of September is so much better then January for expediting tier changes.
It will take time but in 2021 Generic Lovaza will be wholly replaced by Vascepa (means if that was today the V scripts would double). I believe FDA approval and tier changes in particular are a huge catalyst to be easily 2 billion in sales in 2021 minimum. Tiers will change in 2020 but it's a rolling effect between getting the tier changed and getting people in for there annual visit. 2020 will see accelerated growth but believe 2021 is when it finally goes ballistic. (Inventory increase, insurance tiers well established, marketing penetration high, debt completely paid off).
Logical, NVS said we will buy you in 2019 after FDA approval and we can invest in manufacturing to boost capacity to 5 billion way sooner than you would be able to on your own. Seems like that's what was in his head LOL
On the other hand, maybe We will see a report out tomorrow stating JT said patents expire in 2019 because generics will win suit this year and they have 5 billion in capacity already waiting, and for $20,000 I'll send you my complete report/analysis that will prove this(if you ignore all rational thought and science).
Oops, last part was supposed to be in fine print and invisible ink....
Whatever he actually said he meant 1 billion. He even Followed itt with the fact that they’ve stated this before.
Interesting that someone is using plus one coins to advertise certain horrible posts. I never even noticed such a thing until toady. They really did not expect Priority Review. Thought they had more time, just a question how close to approval will they be done holding it down, this will move up fast as they all exit. THEY ARE SO FREAKING NERVOUS makes me wonder if BO is solely waiting on FDA approval.
My next PUT options I sold expire in July. I think I can probably sell the closest Put option for August or September at that point as stock will clearly reach $20 sometime near the approval based on the short action. Might make sense to go long and sell higher calls but I have a limit to be invested in each stock and would put me over the limit. For selfishness I hope they have another 5-6 weeks to keep this from running so I can get another chance to sell options a these low levels.
If you have enough experience you can just tune out the noise.
Once FDA approval happens (and it will) all this nonsense will be meaningless.
Sorry I just saw your PM, I don't have ability to send PM so don't look at my messages often.
A few things on options, depending on your broker you may not have access to more advanced options play. They usually require a self survey to set your level of trading so if you have not done options before you might be currently limited to Calls and Puts Selling only.
As to a play for October and stock being over $20. The problem you have is the volatility is high so cost is high. If you buy $20 calls outright they are around 2.40 so you lose money if stock is below 22.40 and you lose it all below 20. With a range of 20-24 you could buy the $20 for 2.40 and sell the $24 at 1.34 for a net 1.06 and anything above 21.06 becomes profit.
The December monthly option is 2.90 last sold, if you want to do a straight options play I'd recommend that over the October, even better IMO Jan 20 is 3.30, so you could buy 15 call options and can double your money at 26.60, where the stock would need to be at 36 to double your money if you bought stock outright. January also gives time to have a BO, or GIA catalyst such as a preliminary forecast for 2020 from company. Of course under $20 then you lose it all and under 23.30 is a loss and if they GIA and decide to dilute who knows on short term stock price. You could also sell the same # of 30 calls to bring that down a dollar. I doubt would be over 30 unless BO, and even if that happens your options are worth $10 and you paid NET 2.30 or so and a very good return.
I'm a big proponent of selling options but you need a good sized cash balance. Selling options is a better conservative approach but with only $5K or so your upside is much bigger in buying the calls outright but you have to be willing to risk losing it. I would stick with the monthly and not weekly if you plan on doing something (better OI and smaller spreads due to higher volume). Though price moves less the further out you go, with market on recent upswing you can probably wait until AMRN touches low 17's again if market takes another dip or if they announce an Adcom and temporarily drops.
Again, can't overstate enough the fact buying options straight can lead to total loss and you must be prepared for the high risk and reward. Also the prices can have a wide spread so you'll want to make sure you get a # that you can live with if you buy or sell. Use a limit for sure.
I guess this is what happens when we wait for FDA approval and the stock floats in a tight zone. FYI, FDA approval is a slam dunk. So put people on ignore or ignore them and the board won't be so full of the same posts and responses.
The fact is Vascepa IS getting expanded label in 3.5 month or less, nothing reported or said here or any posts and reports by any biased nutcase will change that fact.
There are hundreds of studies showing pure EPA works in various ways and have also shown how it works and now with RI those trials are multiplying and will confirm everything that us educated people already know. I think most have learned a lot on this board on the multiple mechanism's of Vascepa and the things it does and why.
Store your bags, put your tray tables up, sit back and enjoy the ride, it's a long flight but the landing is coming soon.
FDA label question. I guess it is time to start some due diligence related to FDA labeling. With Statins use increasing and guidelines seemingly changing regularly to increase those that are recommended to be on Statins combined with the fact a large percent of people stop taking Statins due to side effects is it possible for FDA label to have something like:
To be used as an add on to Statin use OR as a standalone for patients that cannot tolerate Statins.
Even adding some caveat With the possibility Amarin is to track success of those that can't tolerate Statins as compared to the RI placebo group and FDA can revisit that part of the label depending on future info received from this type of use.
If so is it possible many people that are captured under the wider guidelines for recommended Statins use would think, I am borderline, I don't want Statins, my doctor or I will agree I can't tolerate them and just give me some "V". Thus, perhaps, in some backward way we could get a de facto study of Vascepa without Statins? Though the main point is the sales potential of "V" could be higher than Statins due to the minimal side effects.
Which reminds me there needs to be some advertising tie in to the "V" in True Blood and how badly V was desired and needed. I have a whole commercial in my mind but if you never saw the show it's wasted LOL.
"human blood sustains life, vampire blood is life." just replace human blood with statins and vampire blood with Vascepa...
OK I digress there at the end.....HA
And the winner of post of the day!! Congrats!! And I'm calling it early in the day. You sum up my thoughts exactly.
There was a large analysis of a large number of statin studies years ago that pulled out this and that data and concluded if you had a previous heart attack statins prevented a certain amount of deaths, if you had not had a previous attack the statins had zero death benefit. Other studies dispute that somewhat, you read enough you can find a dizzying array of opinions on statins.
A recent analysis not related to just deaths had this note:
"There is substantial disagreement on which patients without known cardiovascular disease (CVD) should take statins. In this latest effort to address potential benefits and harms of statins for primary prevention, a Swiss team created a complex model based on data from randomized trials and observational studies. The model also incorporated competing risks for non–CV-related death and results of a survey of patients' preferences for avoiding adverse CV outcomes and statin side effects.
The 10-year predicted CVD risk above which the model predicted net benefit ranged from 14% (for men in their 40s) to 21% (for 70- to 75-year-old men), and from 17% (for women in their 40s) to 22% (for 70- to 75-year-old women)."
This analyses tried to adjust for risks of taking statins. I think generally statins are over-prescribed but mainly due to uncertainty as to which people will really benefit. Weighing benefit vs risk is always a balance.
It would have been interesting to see RI results before statins were a thing and you could really compare the 2 as front line treatment, never going to happen now.
They all sign non disclosures, I don't know rules in terms of public companies but someone posted awhile ago a filing that detailed the history of a deal and prices were discussed a year plus before any deal and any announcement so I would guess unless there is pen to paper on a deal they don't need to announce anything. Makes sense, would open up a huge avenue of stock manipulation.
It could be that BB and the board had preliminary discussions and feel based on what was discussed with BP and what path they want to take that selling the company is the preferred route. They will know more after FDA approval is my guess. If they are wrong and BP tries to screw them with low ball offers after approval they go ahead and hire and call the bluff.
If they believe they are going to sell why hire people, train them, have all that expense and then let them all go a couple months later? If you have to GIA, even for a short time after FDA approval because offers do not materialize as you thought you lose basically 60-90 days of time on added sales staff, probably worth the cost/reward.
On another note, other than hiring, there is not much they can do until approval of expanding label, They can still prepare a marketing blitz but we would not know because they can't release it until after approval. It's really partnering and sales hiring that could be done now if they think GIA is the likely path, and they could still do that later this month if that is the path they choose.
Deals fall apart at last minute all the time. You have to weigh risk/reward and think JT has a strong team guiding him.
It's actually pretty simple. I have been in the loop on multiple private deals with private equity and not the same as this level but thought process of buyer and seller are very much the same andthey all went to the same business schools.
They analyze numbers, they analyze EVERYTHING.
So BP will sit there and go, what are expected peak sales, what are total sales expected to 2029? What does the company say they expect? Now let's poke holes in that, what are the risks to that #.
So if they say 5 billion peak sales is what there analyses says is fair. They reach that # in 2022 and it maintains that level for years, say they can come up with 50 billion in reasonable sales for Vascepa by time generics come in.
They will look at other potential uses, however that will be heavily discounted as having any potential because most drugs fail at additional indications and it takes years to find out and money to invest.
They will look at possible OTC sales after generics, but again discounted heavily the further you go out the higher the risk. It is all risk and reward. It's 90% risk analyses and 10% reward analyses.
What's the risk of generics earlier, risk of competing products etc...
I think $50 billion is reasonable assumption as a number they may look at. You have to discount future dollars and also take 20% off that for costs to manufacture so $40 billion can hit the bottom line over 10 years. If you pay 40B for that you lose due to time value of money so can't pay 40B.
So BP will say I can pay $20B(about $50 a share based on 400 million shares) if those numbers work out as I think.
So you don't offer $20 now because what if FDA says they want more studies, or denies or limits expand label, and then what if generics win suit and are in market in 2 years or you overstated the potential so you offer a lower #, say $12-13B. Amarin says we want $20B for example. Amarin knows de-leveraging risk is the key so will wait out FDA approval and BP will pay a little more then, will settle generic suits to 2029(hopefully), now fully de-risked as they can be. No debt, long run time, FDA approval!
BP willing to go up to say $15B, Amarin comes to $18B, do they bridge whatever gap they have? Do they want to add CVR's for potential other indications or higher Peak sales? BP probably wants to avoid that unless they can pay less, like $10 and lots of CVR's that can get to $20B or higher. Amarin refers $20B Plus CVR's to higher. Whether they bridge that gap is whether a deal gets done. BP knows Amarin will ramp slower than they would, may need to get money, have to spend for additional pipeline drugs, they know they have some leverage as GIA is a hard trail to take so they can negotiate hard as well as Amarin that has the bB drug has there own leverage.
Every BP on the planet would buy Amarin tomorrow at a certain price. My experience through deals is the weight put on risk is extremely heavy. As Amarin De-risks the price goes higher and a deal gets done. Is it possible to get done before FDA approval? Of course, but assumes BP is almost certain nothing will derail the expanded label, if you buy now and a surprise happens you get fired so they will wait unless there are competing offers and don't want to be left out if someone decides to go aggressive now.
De-Risk, De-Risk, De-Risk.
Yup, This, absolutely This!
WooHooo! 1 Day closer to huge stock gains!
They don't need it, you headline bankruptcy and Amarin and algorithms will sell. Someone paid for a hit piece to:
1) Bring price down to get in at a good price
2) Cover a short
3) 1 and 2 above
We know it is a hit piece beyond doubt.
Someone thinks Amarin is going up, not sure that's a bad thing. Manipulation happens, doesn't change the fact post FDA approval the stock is going much higher.
The poll would have one answer: Buyout
That's the only thing that logically explains all those decisions.
Based on FDA history I'd say if we don't hear about Adcom by tomorrow AM the odds start to drop significantly every day thereafter and if no Adcom news by June 11 in the AM I'd say the odds would then be extremely low of having one.
I'm not sure if having and Adcom is positive or negative, I think more positive because it would have unanimous approval vote. But Adcom's are also set up to play devils advocate and poke holes so the fear of that leading up to it and during could be harmful to stock. In the end I think it is irrelevant as the label gets expanded with or without it.
I will say the fact one analyst and JT have indicated Adcom is slight positive and company looking forward to one to show off Vascepa results etc.. is all a little odd, perhaps they think an Adcom is normally seen as a negative and trying to paint it positively if it happens.
I'd like an Adcom just to give us something to talk about besides cannibalism and nonsensical rants. LOL
They can borrow enough to pay them back
They can ask for a waiver due to coming growth (They could get it if Pharmakon wants payback sooner and who doesn't)
I don't think that stipulation is a stopper at this point in the company growth, made sense when they had bankruptcy potential. I'm pretty confident with FDA approval they would get a waiver on that condition.
As long as it retains volatility it's a great options selling play, and with confidence high it will move up after FDA approval you alleviate downside fear. You can get 70% return annually just selling puts right now (of course volatility and strike price vary so not that simple) as long as it stays from 14-20 and you smartly choose your strike price and month you can do well and lower your core basis.
I think there are hedge funds looking to take positions and they generally use tactics to keep price down, I like that JT is out there trying to get larger institutional interest which will eventually lead to pricing pressure to the upside. I believe when this does move up to the next level (above $20) it will happen in a matter of a day or 2, just the nature of the stock.
I also believe if market is down 10-20% 6 months from now Amarin will be up. Lots of reasons to keep money in Amarin one way or the other, obviously the bulk of money should be more widely invested and thus most of your portfolio would benefit from a day like today.
Everyone should just Enjoy the summer and ignore the daily stock price since as long as fundamentals are not changed there is nothing to worry about.
They will very likely update guidance at the next earnings release. It would be unusual to do it in between, it's normally done with earnings releases.
JT did say
"Such guidance assumes that the approved label for Vascepa is not expanded by the FDA during 2019. "
It's possible they do not raise guidance until after FDA approval but logically they would update guidance slightly with the caveat it assumes label expansion by FDA in September.
They are clearly graduates of the Steve Jobs sandbagging academy and that is not a bad thing long term but they need more acceleration in revenues and higher beats before it will reflect in stock price. Better to be conservative than give a real best estimate and come up short.
We are less than 4 months away from when, as JT said, the "exciting" part starts to happen.
Oh God no, anything but a convertible offering.
Thanks, too lazy to go look it up myself HA. So they need 743 million in sales from April 1. Impossible to tell what ramp of sales looks like after approval but they will be paying back into Q1 next year in most scenarios and possibly into Q2.
I believe debt was about 93 million at year end 2018 so would need 930 million in sales to pay off. So would not be paid off until next year sometime assuming they can get the sales ramp going after approval. Hopefully get at least half paid off this year.
Isn't it a 10 year window and it would be almost a year to get approval?
It seems like low bar to get this filing done, I don't see a need to worry about the EU market in 2031 vs 2032 vs 2020 and 2021 when US generics are 2029 and are going to be the bulk of sales. We have no idea what competitors or changes will happen in 10 years but you know TODAY you can sell the product.
The only reason they don't have anyone to sell it is because they just decided to not get anyone to sell it, not because they can't.
I don't buy the reasoning at all, you have a whole year once you file to figure it out, decisions don't take that much time.
I don't quite get the "aiming before the end of 2019" date for European submission. It takes EU another year after that to approve, seems bizarre.
In GIA scenario it seems like complete mismanagement of an asset. In BO scenario seems like filing being further along would be better, is Amarin really afraid of not filing correctly and leaving for BP? The basically stated they probably want to file and have approval before partnering there to "de-risk". Well faster approval, means faster EU partnering!
This question has never been answered well by JT, I can get they can wait to partner, more value after FDA approves and EU approval theory, but then why not prioritize the EU filing? What are the people that did the US filing doing with themselves?
For 6+ months they have said:
While we have received expressions of interest from companies regarding European rights to Vascepa. We have not decided, whether who is best to partner in Europe before de-risking the regulatory process or if it is better to wait. There are pros and cons to both approaches
Maybe I can help them Google decision making models. Are they waiting or are they not? List the pros and list the cons and make a decision, this takes more than 1/2 a year to decide?
I'm pretty sure they are not completely incompetent which the above info suggests. I think they realize it's indefensible to be so slow on EU, especially when they stated there are "slight differences" between US and EU filing, thus the brush off answers, which only leads me to believe they think there is no way they are ever going to have to worry about it since it will be the concern of BP.
So after the SNDA is submitted, we will turn more attention to the prioritization in Europe. Key there is that the data that will be submitted to the FDA with slightly different format should be the basis for the filing for Europe,
Of course he’s paid by someone. Hedge funds most likely.
What's anytime soon? Between now and Within 1 year after FDA approval is the timeline where BO makes sense, after that only makes sense if they poorly launched new indication. I would guess there are some nice stock options in her future, including change of control, she'd be crazy to take this job without that.
A company I worked for hired a new CEO, 6 months later the company was put up for sale, new CEO had huge bonus if company was sold and it was. In hindsight He was hired solely to prep the company for sale, only the owners were aware, everyone else thought it was due to the massive growth we were experiencing and needed and experienced guy to take the reigns forward.
The description below sounds like something useful when selling the company since her main goal is to deal with key stakeholders. Was there a big clamoring for GIA launch to communicate with key stakeholders to increase sales? They are clearly trying to increase institutional investment, which they should, but also a higher stock price gives them more leverage in a deal and less pressure from shareholders to settle for less, especially if you communicate to these key stakeholders how valuable the company is.
"she is charged with advancing and implementing an integrated, progressive corporate communications strategy designed to educate key stakeholders about the company and its lead product, Vascepa®."
ONE other link shows they acted on 92% of PR's within 6 months for the one year 2015 but previous years reports were as good or better so the vast majority make the PDUFA Date.
FYI thru Sept 2016 they were at 100% that were done by PDUFA Date.
I think it is safe to say the evidence is extremely hgh that the September date will be met and not pushed out. How much earlier could they get approval? I think that will require finding individual drugs that got earlier approval.
https://www.fda.gov/media/103503/download
Based on link below the median total time for approval from submission was 8.0 and 10.1 for PR and SR respectively FROM 2014-2016 I did not find anything better than those total averages. Before that they were right at 6.0, I am assuming there was a push back to 8 months instead of 6 and we are back to 6 so I would assume they are right around the 6 months. Is a median time so more limited than average but best i can find.
I know 6 months is the FDA goal CURRENTLY that they are supposed to reach and they are generally meeting the goals so I don't expect it to run late.
This link goes to 2016 and 2014-2016 are all 8.0
https://www.fda.gov/media/102796/download
Based on everything it seems most of the time they hit right around the date so I suspect we go to late September and very close to the date.
There is interesting #'s on link below but nothing directly to the question at hand.
https://media4.manhattan-institute.org/pdf/fda_07.pdf
I think is automatically set at 6 months from Mar 28 submission. It's a goal date not the actual date.
We should hear on Adcom or not by June 10 the latest. They try to have that announced by day 74.
Also from FDA goals:
"FDA intends to convene ADCOM meetings no later than 3 months (standard review) or no later than 2 months (priority review) prior to the PDUFA goal date."
So Adcom would likely be late July so a short window from announcement of Adcom to actual Adcom. Adcom would cause some uncertainty in stock leading up to it but once over it would give upside to stock price as unanimous vote for approval would lead all to believe approval from FDA is formality.
I have learned more details on FDA processes and timelines then I ever wanted to know HA
6. Increase timeline of those investors that "had months to take a position"
I think there was something to a standard review meaning dead money in AMRN for months but now those that have been on the sideline have smaller window to start getting in stock before approval and, as JT said, "exciting" times.
Sounds like a guaranteed BO announcement Monday LOL.
Odd the PR news made you flip to GIA, it was high odds of happening, nobody really doubts eventual approval, I can't see why this changes anyones opinion of BO vs GIA.
I expect a BO because it makes sense for many reasons IMHO.
In the end it's not a question of what we WANT, its a question of the thought process of top management and large investors. I think they are heavily in BO camp but we will see soon enough.
It just seems like the answers are so obvious to all of us that they would get PR and then easy expansion of label you sometime start questioning things even though your logical brain says PR is so obviously got to be granted, I mean it was unprecedented success in the number 1 killer disease. Duh! This was in the bag from day one and we all really knew it.
Yet I first pumped the air a couple times reading this news. Go figure.
I honestly don’t care how stock price reacts between now and next 4 months as stock is worth double this current price after approval even if JT does a poor job launching, ignoring more likely BO scenario, it would still be there eventually , just a question of when.