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But press release says nothing to that effect:
Amarin intends to use the net proceeds from the offering (1) to support the ongoing commercialization of Vascepa following REDUCE-IT results, including (i) seeking regulatory approval to expand the approved label for Vascepa based on the cardioprotective effect of Vascepa demonstrated in the REDUCE-IT study, beginning with submission of an sNDA to the FDA in early 2019, (ii) expansion of our sales force, and (iii) support of expanded commercial operations; (2) to increase commercial supply of Vascepa from third-party drug product suppliers; and (3) for general corporate purposes.
In the interview he did say that there is a lot to think about with Europe deal and if it might be better to wait until after FDA approval. So it is possible they want to wait until late next year for Europe deal. I expected a raise but thought, based on his interview, he would wait until January scripts and see how fast they ramp up and then decide how much cash. A 3% dilution, if accurate, is not a big deal but those in for short term BO or partner might sell, and it will be all about scripts until FDA approval I think. GIA as long as possible has highest upside but highest risk. Street probably take positive overall but I think some may question if $200 million is enough and if they will raise again after FDA approval. Scripts have to ramp fast in 2019, hopefully this money makes it easier to do.
One study? The recent study looks at 34 studies, I take a 200,000 plus population from a more recent analysis,
Again proved my point, you take an 8 year old study instead of a widespread analysis from 2018 AND ignore, as usual all the other points. Yes makes sense, we should accept older data and ignore new updated data, great job. I’m sure you saw the multiple other experts that agreed with me recently and the recent conclusions that you should not fixate on the LDL numbers under 100 because there is no scientific proof there is a big difffence between 70 and 90 because you can Google but apparently can’t Google recent information.
Conveniently also ignore all reasonable arguments and did EXACLTY what I said you would do, ignore all data pointing to you being wrong.
Hmm biased much.
Fact, new info says you are wrong, Fact, you can’t accept being wrong, not worth the effort. You have proven me right about you so done with replying to your ridiculous posts. Ciao
Statins reduce LDL by 50% or more, there is a study that shows 79% of people that went off statins saw the LDL go from under 100 to over 100 vs 3% of the statin group(yes 3% of statin group went from 60’s to over 100) in a group with LDL in the 60s at start of trial but started on average before statins at 130’s. This was only a 10 week trial.
Since studies show statins have little or no effect for people starting under 100 I assume most in RI were above 100 before statins, if so if statins were blocked then 79 % of them in RI should have gone above 100 and significantly so, you can’t have overwhelming proof statins drop LDL 50% or more and then say statins were blocked with a small rise when reverting to the mean is a perfectly logical explanation.
If someone is really saying that statins were not working and all that happened was the small increase then all the studies on statins that show it’s large effect on LDL apparently are now fraudulent?
I have not even gotten to the fact that there is zero evidence LDL under 100 leads to heart events.
In addition to that non-statin fact Statins have shown to not work in people starting under 100 LDL. Yes understand people did not start below 100 before statins but there are no studies that indicate small changes in ldl under 100 are harmful.
Statins were obviously working:
1: LDL did not increase as they should based on people stopping statins having large LDL increases
2. Statin side effects were still happening
3. A large number did NOT have LDL increase, almost impossible if statins were not working
4. Even people on statins can have LDL go from 60 to over 100 in 10 weeks so small overall movement not that meaningful
5. The fact the effects were mostly early on and then moderated or were less over time highly correlated with reversion to the mean rather than statins not working, why would things not get worse the longer statins blocked, especially when they were not effected by any large percentage to begin with, makes no sense
If statins main benefit is this small on LDL difference in 6 years.....I don’t even have a finish to that sentence because it is such an absurd thought...If statins were not working things would have recorded much much worse.
Interestingly new rx was up for Generic Lovaza as well though not as Miuch as Vascepa, but also was down on refills, I wonder if we might see some residual gains there from the news of RI from the uneducated until they are educated. Considering some will hear “fish oil” and not “epa” and both are fda approved on label for same indication.
Long term not an issue but will be interesting to see the trend of lovaza new rx as time goes on.
Too bad we need we need to wait 2 weeks to get the next full week of scripts, needs a big jump in January if 1 billion is the goal in 2019 then about 60k in scripts is where they should want to be in 1q. Since these Friday released numbers don’t include all scripts we need closer to 55k from these numbers in January.
Starting in 2 weeks will be fun to watch script growth.
Honestly the way the post was written I was not sure either at first until I looked it up. The other question is the 3 million share traded, was that the MM gaining inventory based on this option move or did the option person also buy shares to protect against a buyout?
Clearly someone let MM's know and arranged this whole thing ahead of time.
Jan 18, 2019 is expiration date and 21 is the strike that both were executed at
https://www.nasdaq.com/symbol/amrn/option-chain?money=all&dateindex=2
They are both at Jan 21 strike
So stock is below 23.10 and above 14.65 on Jan expiry and they make a profit? I think i did that right but did it in my head instead of making the effort to Excel it. MM then needed to make sure they had shares available for option expiry thus the 3 million shares going through?
It is a weird trade, must have been able to get option pricing that gave them a nice scalp. Will need to look at options open interest after today and see if there is still a large open interest in either calls or puts and might help determine what they did.
I posted a summary on Facebook page and copied below and was 3 posts so all 3 below
Just listened to a good portion of the Sirius interview with Dr. Bahtt. I caught the last 25 minutes and it ended at 7:30 but not clear what time he started.
The host was very positive towards the drug and called it practice changing. The host was also very complementary of the doctor and said he knows how detail oriented he is from all the other trials and clearly had a huge amount of respect for Dr. Bahtt. I don’t think there was anything earth shattering. The host asked why he said in his first interview that it “might” be practice changing when it really is and Dr. Bhatt said that when you do the trial you always try to remain conservative because you’re a researcher and that should be your approach but that yes he agreed its practice changing.
They address the mineral oil again and the host said he does not buy it and Dr. Bhatt originally answered that it was a large number of shorts that were angry over losing a lot of money and that there are a few doctors who love to be interviewed and be in the limelight that didn’t even read the whole study that were to blame and said that even if you bought that the mineral oil had some affect you are talking maybe 2,3,4 if you want to be incredibly generous 5% difference but he said that it did not affect the trial and the host followed up with I don’t buy that it was 20% and that there was any effect that it was actually 25% and the host mentioned the odyssey trial and another trial where the placebo group had a similar jump. They compared it to the first statin trial in terms of importance
They also mentioned regression to the mean how in order to get into the trial you had to have LDL below a certain level so people may have got there LDL down in order to get into the trial and then it went back to the normal level
Overall was of course very positive and the host was basically in love with Dr. Bahtt and Vascepa
One thing I forgot, the host stated to Dr. Bhatt that his presentation at the AHA might have been the best, most detailed scientific presentations he had ever heard for a trial result and that his presentation was extraordinary. It was unclear if the host was there at the AHA but if he was he definitely was giving a standing ovation at the end. The host seemed to be some type of Dr. with cardiologist background but not 100% clear what his credentials were but he was a doctor.
I believe this was the host based on his name being listed on the same show multiple times on the Sirius website
Dr. Fred Feit, an internationally-renowned interventional cardiologist, likes to accentuate the positive on his weekly program Heart to Heart. You'll hear stories that will inspire you as well as make you laugh - and also take away the best medical information available on the radio. Dr. Feit and his team at Bellevue Hospital helped revolutionize the treatment of patients who suffer heart attacks, but for Fred it's not about his legendary technical skills. He loves treating the whole patient and not just the blocked artery in isolation.
It's not the first article to detail how little statins really do for most people. It is amazing that people(FDA) take a study being successful and determine everyone should take statins and ignore the detail of the studies. That is one of the problems with science-they tend to take a study outcome and not analyze the details because the outcome is what matters most.
Well, in this case it is killing Vascepa. They take study results that are negative and ignore the fact they were positive in the Anchor population and they take statin study and ignore the evidence it helps very few people.
The ignorance of the scientific community sometime sis amazing and frustrating.
They cost money and all resources were geared towards Reduce It, They totally expected Anchor approval and thus increased cash flow, high profitability and then followed by Reduce IT success. With that its multi-billions of dollars, they would not need any other trials but they could also, at that point afford to do them and be highly profitable.
They relied on SPA and results and just assumed Anchor was in the bag, which it should have been.
A very strange time to take a stand on trigs. Vascepa, the FDA admits has zero safety issues, they admit the science is not conclusive either way YET they deny Vascepa in Anchor. Really illogical based on safety data regardless of other outcome trials so not surprising management was blindsided by denial and SPA being pulled.
The only caveat is FDA mentioning these other trials that were to be completed that mat change SPA, management should have been more aware of the complications from those trials than they were. However, the safety profile and the clear success of Anchor trial made them ignore the small red flags that grew to become giant red flags.
Let us not overstate Statins. Very few people have life extended by statins
http://chriskresser.com/the-diet-heart-myth-statins-dont-save-lives-in-people-without-heart-disease
An analysis by Dr. David Newman in 2010 which drew on large meta-analyses of statins found that among those with pre-existing heart disease that took statins for 5 years
96% saw no benefit at all
1.2% (1 in 83) had their lifespan extended (were saved from a fatal heart attack)
2.6% (1 in 39) were helped by preventing a repeat heart attack
0.8% (1 in 125) were helped by preventing a stroke
0.6% (1 in 167) were harmed by developing diabetes
10% (1 in 10) were harmed by muscle damage
Moreover, these results do not apply to all populations across the board. Most studies have shown that while statins do reduce cardiovascular disease (CVD) events and deaths from CVD in women, they do not reduce the risk of death from all causes (“total mortality”). (2)
Nor do these results apply to men or women over the age of 80. Statins do reduce the risk of heart attack and other CVD events in men over the age of 80, and especially at this age, these events can have a significant negative impact on quality of life. However, the bulk of the evidence suggests that statins don’t extend life in people over 80 years of age, regardless of whether they have heart disease, and the highest death rates in people over 80 are associated with the lowest cholesterol levels
The only population that statins extend life in are men under 80 years of age with pre-existing heart disease.
In men under 80 without pre-existing heart disease, men over 80 with or without heart disease, and women of any age with or without heart disease, statins have not been shown to extend lifespan.
Statins do reduce the risk of cardiovascular events in all populations. A heart attack or stroke can have a significant, negative impact on quality of life—particularly in the elderly—so this benefit should not be discounted.
However, the reductions in cardiovascular events are often more modest than most assume; 60 people with high cholesterol but no heart disease would need to be treated for 5 years to prevent a single heart attack, and 268 people would need to be treated for 5 years to prevent a single stroke.
Statins have been shown to cause a number of side effects, such as muscle pain and cognitive problems, and they are probably more common than currently estimated due to under-reporting.
I'm not sure why this is news, I posted ahead of time why BP would be for AMRN getting approval because otherwise this means all trig lowering drugs in the future must have long term expensive outcome studies. That's what the FDA has to say to deny AMRN approval for Anchor.
The FDA may very well say that for all indications, marine included because they rationalized the marine approval due to pancreatitis not CHD or trig lowering. So AZN will not get approval for their new purchase at any level unless outcome study, same for all these others.
If the FDA approves any other drug without an outcome trial they are legally going to lose any lawsuit AMRN brings. They won't do it, they need to approve AMRN in December(unlikely) or require outcome studies for any trig lowering drug. Plain as day to me, was the biggest reason I believed BP was for AMRN getting approval.
A few days later, sold out yesterday morning but still appalled at FDA's action here, they all but said we don't care what any established medical society says, trig lowering is not proven to help CHD. Sorry anyone that thinks differently. That approach is based on poor science and poor analysis of studies conducted. ignoring all evidence to the contrary.
They don;t state...maybe there is no benefit, they state there IS no benefit. Ridiculous.
Had to step out at $2 and move on. Will still follow AMRN but from a personal standpoint did not like management was completely unprepared for a no, lack of guidance on where they are going etc...cannot sit around to see if they make good decisions.
Hopeful they get some kind of BP involvement but it was all about Anchor to me and anchor is gone. Now it is all about Reduce It, but that's possibly 4 years away. If they get there and its positive I will be back in. They Have to finish Reduce It, whatever it takes, no other options IMO and the fact they discussed the cost of it and reviewing whether to continue....it's your only asset, it's only value is in Reduce It results....everything should focus on, it should be "how do we get to Reduce It results still owning a solid 40-50% of Vascepa?"...simple to me Reduce it or bust! And in reality it is Reduce It or Bust in every way.
Where it was all about Anchor and that failed it's now all about Reduce It--I was willing to wait until Anchor, but not waiting 4 years for Reduce It.
I will still check in on AMRN and on my watch-list always but learned a lot about biotech's and WS, I still have minimum 10 years(maybe 20) before I need to take my retirement money and make it last, this AMRN experience will be helpful when I get to that point, glad I had the experience, wish it worked out differently.
In the end because of AMRN research I started taking Plusepa for preventative, may some day get on Vascepa for preventative measures, for all I know this AMRN adventure has turned me onto EPA and will add many years to my life, not a bad trade off if so.
For those going to ride out the storm and to new speculators, best of luck.
Sorry to hear md3434, many people got hit hard with this AMRN blow up.
We all love money and this may sound corny but its the truth.
Losing money loses nothing important. Life is about everything but money. If there is someplace to go after we are done here you get to take your memories, your experiences and your love. You can't take money or material things with you.
Obviously hard lessons learned with this one but nobody should be judged by financial mistakes, your truly judged by who you are as a person, how you treat others.
So you are far from ruined.
I speak from some past experiences, not as much for myself, though a little bit, but from others I know, you just go on, live life, don't let a financial mistake ruin any chance of happiness.
I hope this helps, seeing other people in similar situations I felt I needed to put this out there for you. Life is a series of experiences, not all are good, but just being alive and experiencing them is a wonderful thing.
We may trade the entire float plus today, 23 million plus pre market still 15 minutes to open.
Option 2 is the only scenario positive for long term upside, GSK would make sense as a replacement for Lovaza, not sure they can get much, Reduce It is where it is at and BP may wait until they see if AMRN can finance to Reduce IT, if they can't buy everything even cheaper.
There is value here but BP has all the cards now. If they are lucky they can get 200 million for half of the company, only if they can get several BP's interested. I'd take it because instead of stopping Reduce IT, the whole value is in Reduce IT, if Reduce It positive sales are over 10 billion per year, thye need to do everything to get there, it fails they are done, it hits they are in major BB territory.
It's a lottery with reduce It the drawn numbers. The bog HOPE would be late 2015 interim numbers are overwhelming, if not the wait is 4 years.
At cash burn and sales growth and debt payments etc...not going to make it, going to be hard to get financing, BP is the last resort and they are there.
That's what they did, FDA changed it saying lowering trigs is supposed to help CHD so lowering trigs buy itself is not useful without outcome trial.
FDA basically said lowering trigs meaningless, outcome trial needed for any lipid improving drugs for Anchor indications from now on, no exceptions.
Pretty obvious, the Niacin failure, which we thought was good for a competitor to fail was the nail in the coffin, changed the SPA AMRN had since FDA made it clear they did not have outcome trials at SPA creation point.
The movement to Prove Reduce IT will be successful from Anchor lowering trigs was understated. With the safety profile you would think they would not change things with Vascepa. But they did.
They moved the goal posts and stuck to it. That's what was missed.
AMRM itself missed it, the FAQ on their website says:
In accordance with our Special Protocol Assessment (SPA) agreement with the FDA for the ANCHOR indication, Amarin was required to have an outcomes study substantially underway in order to submit for approval of the ANCHOR indication. The REDUCE-IT cardiovascular outcomes study is substantially underway. In February 2013, Amarin submitted a supplemental NDA (sNDA) requesting approval of the ANCHOR indication. The FDA accepted that sNDA for review and assigned a PDUFA date of December 20, 2013. Consistent with our SPA, and based on our discussions with the FDA, we do not believe the final results of the REDUCE-IT study will be required for FDA approval of Vascepa for the ANCHOR indication, although there can be no assurance that this will be the case. On June 18, 2013, the FDA informed Amarin that it plans to convene an advisory committee on October 16, 2013 to review our sNDA seeking approval for the ANCHOR indication. All regulatory approvals are subject to risks and uncertainties. Investors should review Amarin’s most recent risk factor discussion in its Form 10-Q for discussion of such risks.
The bad thing on the FDA viewpoint is the drug is safe and the trial is underway, no harm in approving conditionally. Why not? let doctors have options. Just seem so illogical to deny for the indication for the unknown CV outcome data.
Will FDA go back and extend all exclusivity once Reduce It is successful?
Bad decision, simple as that. Too bad. So Sad.
I guess the question is JZ going to finally sell out and/or give up control or is he going to do everything to get to Reduce IT results?
He should state on CC they WILL look for highest bid for partner and/or BO.
He has to, only real option.
2-3 bucks and then settle down to 2's until PDUFA confirms.
Theoretically they can still be profitable late next year but Lovaza generic 2015 will be tough, they need to sell to someone that can finish Reduce IT or partner with someone that can sell the drug and take interest burden and hold REDUCE IT at 50% of ownership.
They paid close to AMRN $3 a share for Omthera, with Reduce It likely worth twice that if they want to sell out.
Let's see what management says.
Will keep some for long term, await Reduce IT to play out but will move on with rest. Too bad
9-2 against Darn!
I can't watch it anymore, just too stressful, just checking this board once in awhile. It goes back and forth. I just want to vote already
I think the fact the FDA is so comfortable with safety is a good thing, you can nitpick anything if you want to and FDA closed the door on nitpicking the safety, Hiatt is clearly bent on trying to question safety so the drug does not get approved.
I think the thought is perfect safety profile why not just approve, maybe there is benefit, if Hiatt can get panel member to wonder is it perfectly safe? then the focus becomes CV reduction which FDA is on board with hammering. Does seem Hiatt has a clear agenda here. Might be the kind of person rubs people the wrong way thus voting against him for spite.
So FDA and AMRN agreeing on safety nixes many of the safety issues for most panel members IMO.
Anyone get an idea on vote guess? I have no clue? My concern with so many new panel members is the tone is negative, maybe common in these Adcomm's but being a new member you may feel, wow, everyone is against this, I'll vote against it.
My first Adcomm but panel seems to really be leaning towards CV benefits is unproven and unknown, does not sound good to me
You have to wonder, are other panel members rolling there eyes at Hiatt, clearly on the side of not approving OR are they listening to his doubts and pushing their doubts.
The FDA and AMRN say it is safe, it's Hiatt alone pushing it. We need someone to speak for AMRN on the panel.
I think this is the crux of the argument
DA -- no conclusive evidence that add on therapy to statin translates into CV benefit.
WE are aware of positive subgroup data however these data should be interpreted with caution. hypothesis generating and have not been confirmed.
I think since they stated in SPA that these other trials would confirm add on to statin works and since they failed they are saying no evidence add on to statins work for anything
AMRN needs to attack the subgroup analysis as being immaterial and continue to hammer the issues with the other studies.
The discussion will be crucial, its the last thing panel will here.
FDA changed from trig lowering to CV benefit proof. Since Reduce it is the CV benefit proof AMRN needs to push safety and push the evidence that CV benefit IS there.
That's it, they make it murky on benefit and get safety known will get votes, they get panel leaning no CV benefit then will vote no.
Some of the questions got a little to detail oriented, not sure that sways anyone, I think many just tune out.
Very few panel members asking questions. Clearly some lead antagonizes but nobody, to me has said anything that discredits 95% of what AMRN says.
Will the 5% of data that is being questioned sway votes to no? That's the question.
FDA presentation followed by FDA questions and answer session will be interesting.
Is this tense or what! Wish I could drink at work and take the edge off
I guess it's 10:30 not afternoon for FDA reviewer.
With such a narrow focus I don't see how this goes past 3:00
Great job there, negative being he is first speaker and FDA goes last, with AMRN presenting several in a row will all sound good, lets see what FDA brings out in rebuttal in the afternoon.
Also, the discussions that will follow will be key.
However, Dr Miller highlighted many things to discredit other studies and to highlight the fact EPA will reduce cardiac events. Even AF said Miller did a good job.
AMRN management looks like they have prepared well based on the start. Now to attack the mineral oil issue.
Good luck tomorrow all longs!
It's mainly the 1 FDA reviewer and as an extension of her the review team. She goes into great detail analyzing the placebo group and the mineral oil.
Her job was to research the data and find anything that would suggest they should not approve the drug.
The only thing she stated is that the placebo group results are atypical. She also states she finds no evidence that mineral oil is not inert. However, she exhausts all other options and thus wonders if mineral oil is as inert as FDA and others thought, if it is not then the results may be overstated(IF AND MAY). I don't see that as some huge FDA manipulation. I mean it was brought up in AMRN's CC a few months ago, she'd have to be a pretty bad reviewer to not look at that and throw the question out there. She's hypothesizing with very little scientific backing which is why the panel will likely dismiss, even AF says they will ignore the mineral oil argument.
But for her to decide the placebo group, to her, seems like the numbers should not have increased, and then to ignore mineral oil would be bad work.
People forget the review panel does not represent the FDA's point of view on the subject. The review panel for Adcomm has a different job than the people that finally approve the drug at PDUFA.
If the FDA is bought and sold the Adcomm could be unanimous Yes and FDA still vote no, they could just have skipped the Adcomm and then said they want to wait for Reduce It.
OK, free covered call play then, makes sense, free money. The only way that goes to 12 is unanimous decision followed by partner/BO news so did not make sense as a buy.
I did the same play BTW. Why not. Much smaller scale.
Someone get him a Vascepa prescription!
Former President George W. Bush's heart situation that caused him to undergo a procedure in August was more serious than originally thought, as two sources close to the 43rd president now confirm he had a 95% blockage in an artery.
http://politicalticker.blogs.cnn.com/2013/10/15/bush-had-95-blockage-before-august-heart-procedure-sources-say/?hpt=hp_t2
Over 11,000 Calls bought at October 12?
Even if Adcom was unanimous I'd see $9 because FDA could still go against Adcom and FDA employee is one questioning waiting for REDUCE IT.
That's 100K plus bet. Maybe the Put Player has swapped sides. Low is 7 cents and high 13 cents and current bid is 4 and ask 10 so thinking this is a new buy and no closing a position.
Correct, but just saying not sure the panel will be exposed to that argument or be convinced in 1 day that EPA/AA ration is that important. We are not even sure that will be brought up by AMRN.
Your 100% correct and would love it if the panel was made aware of that benefit in that way but FDA is questioning whether Vascepa has any heart benefits. Big disconnect. Just trying to prove to the panel it has benefits, never mind extrapolating out the benefits are so large it can bring down health care costs.