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Actual trading after market open is more important unless there is heavy pre-market volume, like there will be on Thursday.
In just over 30 hours the tone of this board will be interesting.
Good luck to longs and those with potential for CHD-oh wait, that's everyone, good luck to all.
That would be nice, unfortunately they are asking
1)Is it Safe: Yes
2)Is It Effective: Yes, FDA reviewer argues less effective than study shows due to atypical placebo effect but still effective at what it does
3) The kicker: Is what it does safely and effectively worthwhile in regards to reducing cardiac events. If not known should we wait for Reduce IT.
I'm convinced the panel is independent and smart and the way the question is framed leads to an easy yes vote. The discussion is slightly different than the question. The question asks based on safety and efficacy should we approve before Reduce IT. If the panel takes the question at face value its a unanimous yes. If they take the question as a need to guess Reduce It Outcome and determine a vote then we get a split panel.
However the way it is questioned is an easy yes because based on safety(Completely safe) there is no reason to wait for Reduce It. Even the FDA will not say we are 100% sure Reduce It will fail. Unless someone is 100% sure Reduce It will fail there is no reason to deny Anchor expansion since it is effective at what it does and has zero side effects.
The tone of the FDA presentation will be crucial, if they really push the panel to say
1) You must come up with a percent of expected success for Reduce IT
2) If under 50 you should vote for waiting
Which they won't come out and say but if they phrase things that way we get a split vote. Otherwise we get a near unanimous decision.
Will be interesting!!
I'm not a big conspiracy theorist and nothing makes sense for your theory
1) The placebo lipid profile did increase in a bad way, maybe more than expected for 12 weeks, so what was different between the placebo group and the non placebo? Well, the obvious thing is the placebo so the reviewer would clearly see the difference in lipid profile, Omthera company had already mentioned it themselves at a conference call so not unreasonable for someone charged with playing devils advocate to bring it up for discussion.
2) Why would BP want AMRN to fail? The only similar drug is Lovaza, going generic soon, GSK has nothing to gain from AMRN failure. In fact BP has more to lose, AZN now would need an outcome study for Epanova, any cholesterol lowering drug would require a long term expensive outcome study, and FDA SPA's are now going to be questioned as to the sanctity of them not when science changes, as science still says lowering trigs is beneficial, but when some science clouds the issue. This opens ups severe complications for BP. Inconclusive non related studies can be a basis for denial, YIKES!
So BP loses if Vascepa is denied expanded label. The only "conspiracy" theory that could come into play is BP wants to buy AMRN cheap but seems alot of work to illegally pressure the FDA to fail a drug so you can buy it cheaply and HOPE the Reduce it trial is successful since it is not worth much until completed now that you made sure Anchor is not expanded.
Then BP also has to influence a panel of individuals with people from all different parts of the country with different backgrounds.
The theory that BP is pressuring FDA to not expand Vascepa has a ridiculous amount of holes. The first being BP has more to gain with a Vascepa expansion than a denial. Seems pretty dumb to me to be BP and to push for something harmful to your own business.
This is a solid shot at the FDA if Anchor is denied
" We see 5% chance AdComm will demand REDUCE-IT data preapproval,
95% AdComm is fine with it as a Phase 4 commitment.
REDUCE-IT will not yield data until 2016-2017. In the unlikely event
common sense and any value placed on practical drug development
explodes, we think AMRN shares will go much lower."
Do you have the note from them? Cannacord?
Aegis is the most positive where Leerink and Jeffries are basically saying narrow vote approval which is likely down form a stronger approval chance before docs. So risk has gone up and WS is risk averse so regardless of positive analysts WS is reacting to the fear of the negative growing rather than the likely outcome, thus the reset of the stock price. It's all moot in 53 hours.
I would say some analysts has gone from 80% chance of approval to 60% so that's a major shift.
Pop open a cold one sit back and relax, if your set on your position nothing we can do now but wait until Wednesday at 5, none of the trading between now and then has any meaning, now it's solely risk on/risk off trading, longs out before Adcom, shorts out before Adcom, risk takers going on both sides etc...
It's a good article but think the whole position some have taken that FDA is approving Anchor and looking at early REDUCE IT approval a little nutty.
It's clear the reviewer is saying perhaps since the SPA was put in place, there has been a science change that makes the connection between lowering trigs and heart events speculative so should we approve any trig lowering drugs without first seeing an outcome trial.
I do not think it's a case of, of, safety and efficacy is golden, nothing there, let's talk about Reduce IT then...
The placebo part of the article is great info, but I never thought the placebo thing was remotely an issue unless AMRN management is incompetent. Hopefully they are not.
WS is looking for a split or negative vote, negative vote another drop, split vote we are stuck in a trading range, positive vote we will go up and be stuck in a trading range because people will wonder if FDA will vote to wait for REDUCE IT regardless of panel votes. Though odds will be higher of approval so stock will move up, but not as much as it would have if briefing docs did not mention Reduce IT.
I expect(hope), positive vote then late night agreement with congress on debt/shutdown and near 8 at end of week.
I fear, negative vote, government default and $3 end of week
So it'll likely be, split vote mildly positive, short term extension of government funding/debt and 5-6 end of week and lets do it all again in December.
The vote does not ask to vote on conditional, it may come up on discussion and FDA May rule that in December but there will not be a vote on that, the vote is on approval before reduce it results and it is non binding.
Meaningless, the law firm searches stocks with big drops and hopes to hit on some, they are not suing they are advertising in case shareholders are looking to sue,no bearing on Wednesday which is all that matters right now
True, true, except I could lose my entire investment and not effect my life at all financially so in that way not too much invested.
But when you've been in something a long time and the crossroads is a coming....I'm one where I like research, I like DD, not just in stocks but in everything so at this point I still have 2 days before Adcomm, I could get out at $5 instead of 3 on bad Adcomm and I sold some $4 Puts expiring next week I could get out of with little loss so I feel its reasonable to do extra research with 2 days to still take a position with AMRN, I could always add to the position, reduce the position etc., if the Adcomm was Monday would be no point but there are 2 days to do DD and change positions before the material event. Seems worth the time
If they deny expanded indication best case is a 5-6 BO, the only way they stay a GIA company is if partner comes in and covers expenses until REDUCE IT since successful REDUCE IT equals large BB.
If they somehow screw up BO and partner they will likely go BK and never finish REDUCE IT. They could dilute, cut back, etc... but they have interest payment, promised inventory buys based on Anchor approval etc...I don't see how they finance REDUCE IT, so if FDA wants REDUCE IT results they need to approve Anchor, otherwise they are 6+ years away from a definitive answer as they need someone else to start a similar trial.
If Anchor denied AMRN should just take offers to sell and take the best one. Nothing else would make sense
I keep looking at the docs, reading boards, long weekend I seem obsessed, it's sad, can't wait until Wednesday is over.
I keep trying to rationalize a reason for a bad Adcomm vote and my mind can't wrap around it, which scares me more than if I could.
Even with A no vote, the FDA could still approve, a yes vote they could still say they want to wait for REDUCE IT but 3 out of 4 times they follow the Adcomm vote so what happens if a no vote from Adcomm?
Company would wait until December and then if denied would need to sell out like Omthera? With Lovaza generic coming and Vascepa unable to distinguish themselves with expanded indication it would be hard to get profitable in Marine only. Getting cash flow for 3 years to Reduce IT? Only with a BO or partner so we are looking at 5-6 bucks a share maximum in a BO, 3-4 dollars as we wait for December. It's been all about Anchor and a denial here is serving a death notice to GIA long term.
On another note related to briefing docs
I notice the VOTE wording is different than the discussion:
VOTE:
Taking into account the described efficacy and safety data for Vascepa, do you believe that its effects on the described lipid/lipoprotein parameters are sufficient to grant approval for co-administration with statin therapy for the treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the completion of REDUCE-IT? Please provide the rationale underlying your recommendation.
VS.
Discussion:
Please discuss the efficacy results from the ANCHOR trial, including the clinical significance of the observed changes in lipid/lipoprotein parameters and your level of confidence that these changes will translate into a meaningful reduction in cardiovascular risk among the target population
Oddly if you take out the phrase "prior to the completion of REDUCE-IT?" in the vote area there is no difference to the question because obviously right now is before completion of REDUCE IT. Clearly they want them to factor this in but voting itself does not ask the panel as detailed a question as it could have been. They are asking should we approve without outcome trial not should we approve because your opinion says it will reduce cardiac events. A panel member could feel 80% REDUCE IT will fail but still vote for approval based on no safety risk and 20% chance still a chance. Clearly the FDA, when deciding on approval in December will not just look at the votes but will key in on the discussion -especially "your level of confidence that these changes will translate into a meaningful reduction in cardiovascular risk among the target population"
Not sure it is meaningful at all the way the vote question is worded but interesting. I think the wording could lead to a situation where the panel votes yes but the discussion, depending on opinions of the panel could lead to an FDA no. Theoretically.
Exactly! AMRN should highlight this for the panel!
The FDA always has the right to adjust things based on new science. I would imagine the 75 day papers AMRN received had this in it. So I imagine AMRN was aware of this for several months and have been preparing.
The FAQ answer and the analyst notes lead me to believe AMRN was not surprised by the REDUCE IT question but that begs the question why the FAQ that states the FDA has not advised us that we need to finish REDUCE IT for approval is there if they got 75 day papers suggesting it would be a question. So it's a little up in the air when AMRN knew but my guess is 75 days out.
I think AMRN was well aware of the issues and may have only been surprised at the questions about the placebo and the attack on the data more than the Reduce IT part.
I must admit I got a different view of the briefing docs. Though that was after the Friday meltdown and such which led me to believe the docs would be 100% no approval, just devastating so when I read them I expected it to be bad and it was, to my surprise, not so bad.
There were 2 things
1) The Placebo thing but the FDA reviewer went through all kinds of steps to determine in the end she had no idea why the placebo group was atypical, everything seemed kosher but the #'s were atypical and then concluded MAYBE the results are overstated...not MAYBE the results were not statistically significant or that the results would not meet endpoints. Basically if the placebo group stayed the same Vascepa reached all endpoints, just not as strong, not much of an argument against.
2) Now the crux of the whole argument against approval. Since other drugs that effected the lipid profile have not led to reduced cardiac events should FDA now require outcome trials before approving any drugs for lowering the lipid profile. This is what the whole debate will be around. Even in listing all the studies she points out the possible flaws in the other studies. In AMRN's briefing they point out several studies showing lowering trigs prevent heart disease. So now it comes down to a panel, most of them in the cardiac field in some way, who have to decide whether all the studies they learned over the years , including several in 2013, showing lowering trigs is beneficial should be ignored due to basically one study: Niacin. Let's be honest, all the other studies have critical issues, some parameters increased, most others dosage was way too low to have any effect etc...So the amazing thing is the good feeling when Niacin outcome study failed(opening the door for Vascepa to steal market share) is now turning around to be the one thing keeping Vascepa from approval.
Reading some of the past panel's the panels generally seem very well balanced, very fair, they also tend to side with the drug being approved unless there is something obvious as they can also be conservative on safety.
That Vascepa has timed up to be for approval when questions on needed outcome studies have started is amazing.
The other amazing thing is the FDA wants members to discuss the likelihood Vascepa effects cardiac events but in their briefing they ignore most scientific papers on EPA and just mention JELIS. Sure its AMRN's job to push for their drug but the FDA decided it may change the rule they should have spent some time investigation EPA and not just lipid profile comparisons. Now they look solely at lipid profile changes, compare that to Niacin and say changing lipid profile is meaningless. Yet they do not go into HOW niacin works vs. how EPA works. The reality is if niacin was successful the outcome study question would not be open for debate. So it's 100% niacin vs. Vascepa, is there a difference in what they do.
Science and prevailing medical practice on lowering trigs seems squarely on AMRN's side
1)Other drugs such as Niacin are still being prescribed in heavy doses, Lovaza being used off label etc...
2)There are no other similar drugs going for this indication in the near future
3) There is only 1 study that uses pure EPA at a reasonable level that was ever used in a study and it shows it works.
4)Safety is a zero issue
Against
1) Some poorly comparable studies and Niacin have not reduced cardiac events.
It seems logical to let doctors continue to sift through the science and decide how much they value trig lowering and give them a safe option that can help the lipid profile immensely.
ALSO the reviewer in several places tries to make a case against Vascepa and in many cases says she solely is using a hypothesis, there is very little science against Vascepa and she speculates a lot, not science. And the niacin study was also flawed and not related to the people Vascepa is going to be prescribed for see excerpt:
However, this population of 5518 patients was broader than that recommended by current guidelines for fenofibrate treatment: more than 80% did not have sufficiently low HDL and elevated TG (i.e. baseline HDL 40 mg/dl [~ 1.0 mmol/l]; and TG 162 mg/dl [~1.8 mmol/l]) to warrant additional treatment (to conventional statin) according to current clinical practice. The trial established that the combination therapy did not significantly benefit any of the primary or secondary outcomes in this broad population; however, in the 17% of the population with more severe atherogenic dyslipidaemia (i.e. baseline HDL 29.5 mg/dl [0.76 mmol/l]; and TG 284 mg/dl [3.21 mmol/l]) CV events were reduced from 17.3% (monotherapy) to 12.4% (combination therapy) over 4.7 years (p = 0.057). This subgroup analysis showed similar findings to analyses performed for other negative fibrate CV outcome studies.
Again, scientifically, the proof still shows that for the Vascepa population in Anchor lowering trigs works. She calls the above subgroup an hypothesis as here
"Suggestions of benefit or harm from subgroup analyses were defined as hypothesis generating that should not alter clinical practice or regulatory decisions until properly validated, especially in the context of an overall null result. "
However she does the exact same argument against Vascepa. She's talking out both sides of her mouth and contradicting whether you should use subgroup data or not.
If AMRN does not get heavy voting approval its because management failed as the science is there.
I think the key there on the bolded part is that its "some members", I don't think the science is far enough along to get a majority to go that way with a drug as safe as Vascepa.
FDA follows Adcomm vote 74% of the time. Endocrinologic & Metabolic 75% of the time. Interesting thing is Endocrinologic & Metabolic Adcomm's are followed with an on time PDUFA only 33% of the time so be prepared that a yes from Advisory Committee will end up with possibly a delay on PDUFA? Overall they are on time 60% of the time.
http://www.pharmalive.com/how-often-does-fda-agree-its-panels
Amarin website describes Anchor:
A multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal Phase 3 study in patients with high triglycerides (=200 mg/dL and <500 mg/dL) who were also on statin therapy
So it is clear it was run for people on statin therapy.
Someone posted good overview of docs
https://docs.google.com/file/d/0B2TJU8mIVSebNmNxbmw0bWMwSTg/edit?usp=sharing&pli=1
I believe on the Placebo it's irrelevant, the reviewer finds the result unusual but has no idea why. Even with adjustments for the placebo Vascepa works.
I was readings some the the committees previous minutes, to see how discussions go and get a feel for how these things work. There was discussion on making changes to one item about doing further studies to confirm its use and safety and that most member of the committee agreed it would be helpful but they did not vote for more studies due to the "feasibility" of doing more study.
Which leads to the feasibility of Reduce IT question. If they want to deny and wait for Reduce It they would need to discuss the feasibility of Reduce It completing without Anchor approval.
Just something that might lend itself to approve the expanded indication due to no side effects. Kind of goes back to the FDA wants a definitive answer that REDUCE IT will provide and failing to approve Anchor goes a long way to that goal.
Does the FDA reviewer and member of the review staff have any vote on approval or is there job solely to be the review staff? I would assume they don't get a vote in the end as there goal is to play devils advocate but not sure how it all works? In December, who at the FDA determines and votes on yes or no? Is it the same people for all drugs, different people for different areas, different people every time on a rotating basis...? Anyone know
I think most people have a weekend to review the docs and read the story, the damage of the headline is done, it won't be undone but it won't add to the pain anymore. Anyone that sold on the idea the FDA had decided REDUCE IT was needed for approval are likely not buying back until after Adcomm anyways now that they are out.
Anyone know of someone blogging the meeting that would be unbiased(AF excluded obviously)? I Will be at work and not able to listen to most of it. I suspect the nitty gritty will come from the FDA presentation in the afternoon and the subsequent discussions all day to get a feel for the view of the panel.
I'm tempted to ignore it all and then refresh the press release page on AMRN's website at the end of the day and see what the vote was but I sit at a computer most of the day and can't imagine I will be able to do that. AF will have a negative bent on everything said of course. The message boards and such might get convoluted with bears...hoping SR blogs, though he is long biased he will just give the facts with less inflammatory commenting than AF.
On the positive side re:AF he is hedging his view of a negative vote due to safety not being a concern. Even though he believes the Committee will vote no and believes they will conclude REDUCE IT is needed he still hedges with they may approve anyways due to safety profile. So even the most negative person believes approval is not a big reach.
I'd say good thing is we will be done with all the hand wringing Wednesday but if its 6-4 in favor, for example, we need to hand wring through December...
I suspect 8-2, 9-1 or 10-0 in favor but I'm assuming the panel is not predisposed to a negative view and that they will really look at the science as the science makes it an easy vote.
As to vested interest in keeping drug off market, don't see it.
I could see vested interest in getting company on the cheap in BO but getting an Anchor denial would make approval later questionable.
Since Lovaza is going generic soon GSK will be losing Lovaza as revenue stream either way so they wont care. Statins will be prescribed regardless of Vascepa so Statin companies don't care.
BP does not gain anything from Anchor denial, if anything it hurts them as the approval process for trig lowering drugs just went from- prove it lowers trigs to- spend million on a long term outcome study. I don't think Omthera's owners would like that idea. I don't know any BP that would like that idea.
The FDA is asking for the panel to discuss a MAJOR change, the FDA presents evidence in briefing docs that is contradictory and does not really support a major change, it supports a maybe, maybe not at worst case.
AMRN has two things it needs to do in the Adcomm:
1-Show evidence that lowering trigs can reduce heart issues and there is more evidence it does than it does not.
2-Show why the studies that have failed have scientific reason why they did.-This should be easy if they are smart.
The panel will have to decide that lowering trigs does not mean less heart issues-MAJOR change and big leap of science AND that studies that showed no benefit are definitive studies on the subject of Trigs and CHD. Not that niaspin or low level of EPA/DHA don't work but that the studies definitively show there is no benefit to lower trigs in addition to statins.
I would rather be on AMRN's side if on a debate team and not knowing the panel will go with SR when he said based on the panel he only sees one predisposed to a no. If accurate it seems the preponderance of evidence added to the extreme safety should persuade the remaining 9 members to approve.
It had settled at 5.75 when headline came out and immediately went to 5.25 so stock would have been down either way but headline caused a second run down. I emailed the editor and asked for a change to the headline and maybe others did as well as they changed it. Nothing intentional, bad headline writer I am sure, damage done will only be undone by positive ad comm
I agree 100 percent. Finished reading the docs in detail and my first thought was if it's not 9-1 or 10-0 for approval management messed up.
The risk reward section pretty much says approve Vascepa but then they added the risk reward in light of current clinical data.
So basically the FDA is asking if lowering trigs helps the heart. I think the biggest point is the niacin study as it shows improved lipid profile and no heart benefits in outcome trial.
The omega 3 studies are meaningless and easily dismissed. Since niacin works differently than Vascepa should be an easy dismiss also. The VERY recent MIT Harvard study that showed a link to lower trigs and improved heart condition should be brought in, is a huge plus.
The placebo is meaningless as even without adjusting for placebo benefits are shown that are significant. Besides the fact mineral oil is shown in other studies to be inert.
So it comes down to will the panel decide that lowering trigs is meaningless for heart health. If each person decides yes then vote could be no. If each decides lowering trigs might be beneficial it will be a yes vote.
I do not see anything proving lowering trigs is meaningless so I find it hard to believe a panel would vote against Vascepa. To get 5-6 members to decide lowering trigs is meaningless seems unlikely.
FDA agrees they have approved similar drugs in the past
FDA agrees standard risk reward is favorable
FDA wants panel to review studies and see if they can determine science has changed and lowering trigs is not meaningful, and then those committee members have to deal with backlash from peers that believe and have science to the contrary. Or they can vote yes and if REDUCE IT fails they hurt nobody and do not deal with reputation issues by deciding lowering trigs is meaningless.
I just cannot see these people voting against lowering trigs, makes no sense. The details were not as bad as the headline and it all comes down to one question
Does lowering trigs have any bearing on heart health? MIT Harvard just concluded YES. That should be front and center since it is not referenced in briefing docs as it just came out.
So the most recent science says yes so niacin failure is related to how it works not due to lowering trigs
The only way this is not a positive vote is members are coming in with a view trig lowering is meaningless or AMRN management flat out blows it.
If I read the note on the Placebo below I don't see how this is materially effecting a vote?
Mineral oil has been used in other studies? No? Mineral oil is thought to be inert, no? There is no evidence in the doc proving it is not? It even says may be overstated which leads to may not be overstated. There is no way they can get a definitive expert to say the results are overstated and that it is not inert. Sure it can be discussed but not seeing how they will decide, yeah likely the placebo having a large effect. Based on what data is there any proof?
JELIS+Science+results+SPA. Should weigh much more than speculations and maybes.
The changes in lipid and lipoprotein parameters from baseline to Week 12 in the mineral oil placebo group are rather atypical for a trial that included a stabilization period for diet and lipid-lowering therapy, raising the possibility that mineral oil may
not be as inert as assumed. If true, the treatment effects observed with AMR101 may be overestimated
Yes, they need to discuss Reduce it, since it was in the SPA its not a huge surprise. There were no surprises in terms of negative side effects, anything to do with efficacy.
The JELIS trial points to efficacy with EPA, we on these message boards know the science as to why it works and these other studies that have failed and AMRN will also have this info and can pass that along to the committee..
Again with zero side effects, the JELIS study and science along with the substantially underway they will get a positive vote and near unanimous.
The selling related to mentioning of REDUCE IT is crazy. Crazy I tell you.
REDUCE IT is mentioned but considering having reduce it underway was part of the agreement and the main focus is efficacy and nothing related to safety it is pretty straight forward. FDA has said underway is enough, panel should agree with no safety issues mentioned it will be OK to approve.
Expect near unanimous approval on this
Agenda is up also
1. DISCUSSION:
In ANCHOR, 12 weeks of treatment with Vascepa 4 g/day led to an estimated median
-21.5% (95% CI, -26.7% to -16.2%; P<0.0001) change in fasting triglycerides, compared
with the mineral oil placebo, among statin-treated patients with mixed dyslipidemia at
high cardiovascular risk. Changes in other lipid/lipoprotein parameters (selected secondary
and exploratory endpoints) are summarized in the table below.
Median % Change from
Baseline to Week 12
Median % Change
(95% CI)
Placebo Vascepa 4g/day Treatment Difference
Fasting TG +5.9 -17.5 -21.5 (-26.7, -16.2)
Direct LDL-C +8.8 +1.5 -6.2 (-10.5, -1.7)
Non-HDL-C +9.8 -5.0 -13.6 (-17.2, -9.9)
VLDL-C +15.0 -12.1 -24.4 (-31.9, -17.0)
Apo B +7.1 -2.2 -9.3 (-12.3, -6.1)
Tot. Chol. +9.1 -3.2 -12.0 (-14.9, -9.2)
HDL-C +4.8 -1.0 -4.5 (-7.4, -1.8)
Apo A-I +3.6 -2.9 -6.9 (-8.9, -4.9)
Please discuss the efficacy results from the ANCHOR trial, including the clinical
significance of the observed changes in lipid/lipoprotein parameters and your level of
confidence that these changes will translate into a meaningful reduction in cardiovascular
risk among the target population.
2. VOTE:
Taking into account the described efficacy and safety data for Vascepa, do you believe
that its effects on the described lipid/lipoprotein parameters are sufficient to grant approval
for co-administration with statin therapy for the treatment of patients with mixed
dyslipidemia and CHD or CHD risk equivalent prior to the completion of REDUCE IT
Please provide the rationale underlying your recommendation.
Docs are out only 1 question BAM!
I should listen to myself
"Think we will see a bear raid today before docs are out? It's almost better not watching the stock action today."
Not exactly the price action I was hoping for the week leading up to a major event. Crazy Biotech's.
Not necessarily, if the vast majority are scripts are for off label then Lovaza reps have a huge advantage. Vascepa reps need to be cautious as they still have approval for Anchor upcoming and cannot be caught selling in a way the FDA disapproves of as it could lead to repercussions such as a delay in approval.
So Vascepa reps are not selling to Anchor indication at all, and Lovaza reps are likely still pushing it.
Adam Feuerstein Tweet: 'FDA spox on $AMRN briefing document release: \"Sometime today, probably this afternoon'
The online Spreadsheet does not break it down
Big jump in Lovaza scripts at 92,586 or 6.8%.
Niaspan has gone generic and within 2 weeks when from 73K scripts to 36K. Should be a way to track the generic number so you can see true Niaspan numbers.
The first week of October was a huge jump last year for Lovaza also but was 10K higher last year than this year so year over year Lovaza down but first time over 90K since July 12
It's always possible they work for a bear and know a large bear raid is coming or something but having inside info and buying a large OTM Put position immediately before....not logical
6255 scripts all time high for a week
Too obvious for someone with inside info.
Next weeks options still have huge premiums
The 10 Calls still Bid 15 cents and the 3 Puts still get 10 cents so option action is looking for a large move but no direction seems prominent overall in options.
Think we will see a bear raid today before docs are out? It's almost better not watching the stock action today.
Monday is a holiday so 2 working days is Friday which is why they were shooting for Friday, due to the holiday.
Your comment sums up the number 1 factor that eliminates all questions on approval
"At the end of the day, fda wants the reduce it outcomes data. no one in the US has ever done such a study. they know that amrn needs anchor to pay for reduce it. that is the deal between the two - you hit anchor spa and we give you anchor, and in return you give us reduce it data.... thats the deal, period."
FDA wants an answer on this and if they deny AMRN Anchor AMRN may not have the money to finish it. There is too many poorly done or small studies using various levels of fish oil that everyone is confused on whether fish oil works and for what. Reduce It is the only one out there that can put an end to the debate on whether ANY fish oil supplement/prescriptions reduce cardiac events. It's a huge study with large implications, considering Niacin failed, Statins do not extend life at all and heart disease is a seriously killer they need to complete this study.
Right now Vascepa is the biggest hope in finding a product to prevent heart issues and FDA will not shoot that opportunity in the foot by not approving Anchor.