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Thank you Gabor.
Do you know what Amarin's per patient annual revenue (I've heard both 2400 and 1500 here) and per patient profit margin on that revenue (ie Revenue - unit cost only of a years worth of Vascepa)?
He said it wasn't economical for MEDICAID patients not Medicare patients.
What is the link to the fireside chat?
General corporate purposes can be to payoff the loan.
It would be the smartest thing they could do with the money IMHO.
Probably to pay off the Pharmakon loan especially if its a small offering (I would be very angry with management if they made a large 25M share offering).
I've talked it over with JL and he agrees (I know him personally and he said I can mention him). Getting rid of the Pharmakon loan means they can borrow money the normal way and on more favorable terms and won't have to dilute in the future.
Re: Raf You're entitled to your opinion...
What is the profit margin on this revised lower 1500 revenue?
Why I think scripts will grow quickly.
1. I think doctors who don't put their statin patients on Vascepa risk malpractice suits. Defensive medicine is how medicine is done because doctors hate lawsuits. Standard of care and malpractice will drive script growth.
2. It doesn't really to any of our knowledge have any real negative side effects. Anyone who can bear statins will easily bear Vascepa. So no reason not to prescribe it really.
I guess the biggest question inhibiting rapid growth is whether insurers and/or medicare will resist covering it just based upon the Reduce-It study without a label expansion (with a label expansion they will have little choice). In the short term it will save insurers money most likely on surgeries but in the long term sick older unhealthy patients live longer and that may cost them money.
Statins are unpleasant, eating brocolli is something most people consider unpleasant. Vascepa is not. If you are on Statins why not be on V?
The side effects are essentially nonexistent and it will be standard of care to put all Statin users on V. This is probably going to happen quickly
Doctors don't like lawsuits. I'd like to see where my reasoning is flawed but I don't think it is.
By next summer
Almost everyone on Statin's will be on this drug. Thats about 30 million patients of which they earn 2400 dollars in revenue per patient per year.
(2400*30 million)/(370 million) = 194.6$ revenue per share
194.6*(profit margin I am assuming .6)=116.756 profit per share (minus some fixed cost so lets say 100 dollars a share)
So selling this company for 45 dollars is unwise and its going a lot higher then most of you think.
If you can tell me where I'm wrong I'd like to hear it.
JL has a lot of credibility here and I know him. He WAS there and just because YOU personally didn't speak with him is not some kind of proof he wasn't there.
Who are you?
Yeah I think you could at least identify some of them but you would need a network of dedicated people looking at all the connections and then after they were laid out you would need a skilled analyst to put them together.
I know it CAN be done with a large enough network but I don't think I could do it as an individual.
Among the followers of https://twitter.com/amarin_fraud/ is Omax a dietary supplement Omega 3 maker (https://twitter.com/omaxhealth).
A Cardiologist in Chile (https://twitter.com/ecocardio_cl)... but one followed by Beth Israel Deaconess...
A female cardiologist at the University of Birmingham Alabama (https://twitter.com/DrDudenbostel)
The other followers seemed to include more Italians/Spaniards then I would have thought for whatever reason... maybe the rest of you can look more into this when you get bored.
I've found a Nexus account of FUDsters on twitter...
https://twitter.com/amarin_fraud/
I believe that if this page is examined thoroughly we can find some trace of who these people are...
The heartbreak we saw this week was an orchestrated conspiracy of fake news, fake lawfare, and naked shorting. It was not due to "pumpers lying" it was just the opposite it was gloom and doomers lying.
Nobody's market predictions always turn out accurately, but JL given his years of technical accuracy on the effect of the drug ought to be treated with more respect.
The theory of the lawsuit is that Amarin's management in an attempt to decieve physicians and patients utilized a substance "mineral oil" that they knew would block the actions of statins thereby raising the event risk in the placebo arm. The truth of the matter is that Amarin's management had nothing to do with the decision to use mineral oil as the placebo, a decision that was made between the trial designers and signed off on by the FDA.
I guess if you are looking for a guilty party for this decision you'd have to sue the trial designers or the FDA. Good luck.
Legal issue would be conspiracy... to manipulate the stock...
While its obvious to us such a conspiracy existed proving it is likely to be difficult. Someone big like the Baker Brothers would need to fund an investigation probably starting with the law firm. In all likelihood the conspiracy was compartimentalized... each part (the law firm, the articles writers) except for the very top person or persons didn't know about the other parts so the conspiracy is only tracable at its apex...
I've filed a formal complaint with the SEC against Pomerantz LLP, I suggest all others here do likewise.
Given that they tried to frame the president based on an obviously fake dossier it makes sense given the current era we are living in.
The company should countersue the firm, sue fartstain, sue seekingalpha, sue the writers of the seekingalpha articles...
How long will it take to get FDA approval following their new application (6 months, a year)?
How likely are they to dilute again before the FDA finishes their review?
Complain to the SEC
https://www.sec.gov/oiea/Complaint.html
It probably won't do much good but it can't hurt. This is either insider trading or illegal manipulation by institutions to terrify longs. Either way its illegal.
Can Amarin v FDA turn into criminal case? IMO--yes
"the consummation of the Second Private Placement is conditioned upon approval by the Company’s shareholders at a future meeting of the Company’s shareholders."
Does this mean it could feasibly be voted down, why would any shareholders except Sofinnova approve this?
Judge understands the urgency...
This IMHO telegraphs which way he is going to rule.
The only urgency is for Amarin, there is no urgency as far as the FDA is concerned. If the judge takes 10 years to rule what do they care.
Bio I would recommend against filing any complaints against senators without rock solid proof... all you're doing is potentially making Amarin some powerful enemies.
Good job on getting the comments posted... thats a sign that the dogs may be off soon but don't make enemies among the gods.
RE "Boned" by Obamacare
Claim to be an illegal alien with a felony record with kids by several different women whos looking into converting to wahabbi Islam.
They should give you everything for free then.
But yeah if that doesn't work then ask for it outside of your drug plan and pay out of pocket...
Well the force behind the hosing of Amarin don't go to Obama himself...
Hes too busy trying to cram every useless and troublmaking barbarian that their home countries want to get rid of and bringing them to the US and hes too narcissistic to understand anything technical.
The judge can't approve the indication directly...
That is beyond the competence of a court and the court won't decide that.
What he can do is say the FDA's owes compensation for not doing so and that the FDA must abide by its SPA contract unless it can prove it has a valid reason for not doing so.
Yes, you're right, but it depends on the case. Regarding this one, surely it is unprecedented, and then you must consider that "science" and the evaluation of "scientific issue" is involved, and a judge probably won't decide on this kind of matter without experts' hearings
I do not think the court case will take long
These kinds of suits in the federal courts are generally decided on briefs and IMHO the FDA case is very very weak and yes it should be an open and shut slam dunk. The FDA has a bad track record in these kind of cases.
HD, what is your concieved of sequence of events
Amen.
Unfortunately we won't see the order within 6 months (if they continue to appeal it will be still at FDA) and FDA did not breach the SPA, it was terminated entirely by them.
The SPA will be reinstated by court order
In six months as long as the management doesn't do something really stupid (and despite what some say on this board this isn't a realy stupid management, like for instance GTC biotherepeutics had) like drop the appeals.
The federal court is not going to be like the FDA appeals, I supposed AZN GSK or whoever could get to the judge but I think its unlikely. The FDA has a bad track record in these cases lately. The court is not going to grant them defference on their opinion that black is white and even if they do... they took way too long to inform Amarin of that.
In addition the FDA will have to pay substanial damages for breach of contract... as long as the appeal isn't dropped there is no prospect of death spiral dilution.
If the appeal is dropped... who knows.
Big pharma doesn't manipulate share prices...
Only the FDA and congress.
Dilution unlikely.
They diluted before the adcom, they most likely can last through Reduce It even without the lawsuit.
Amarin should consult a proper judge answering if in its situation - in which the last denial was decided after counsulting the superior levels of FDA (the ones Amarin has to appeal to if it decides to go further with the appeals) - a civil suit can be accepted without a completion of the appeals thread.
Article about SPA's
Special Protocol Assessment, a Blessing or a Bane?
http://www.biopharmphysicians.com/special-protocol-assessment-a-blessing-or-a-bane/
It is not difficult to see why an agreed upon SPA would be desirable to have. The qualifier “agreed upon” is crucial, however, as an SPA is, in itself, nothing more than the FDA’s comments on a proposal, delivered within a 45 day time limit. An SPA can be appealing to the industry since it is sometimes difficult to get timely feedback from the agency, Once FDA has indicated it accepts the protocol, a company will assume it has a written contract with the reviewing division assuring acceptance of the proposed efficacy claim if the data fit the prospectively defined success criteria. This is perceived to reduce risk by eliminating the fear that a positive outcome in Phase III might not result in approval if the trial design is not acceptable to FDA. Obviously that kind of risk minimization is alluring to analysts and board members. But, as always in life, things are not as straightforward as they may seem on first glance.
How does Amarin benefit in any way from dropping the appeal and thus losing the ability to sue the FDA in federal court for break the SPA?
They have lawyers on staff they have to pay anyway.
They do have to wait for the appeals but so what... its likely to be less time then it takes to complete reduce-it. The FDA's word and goodwill are absolutely worthless.
I don't see how this could be lost in court other then whatever big pharma that is involved outright bribing or blackmailing whatever federal judge (which is a very risky and iffy proposition because judges are guaranteed an upper class life anyway and the only way they can lose it is via being caught doing something like that).
I also don't understand how the SPA is not a contract, I looked up the difference... it basically says that agreements are "informal" and vague whereas contracts are formal and specific. The SPA is many things... but it is not informal.
http://contract-law.laws.com/contract-law/contract-vs-agreement
Why should they give up suing the FDA (if you are talking about the irrelevant NCE I agree with you)
Its an open and shut breach of contract case.
Its critical that Amarin not drop the appeal so they can eventually sue the FDA in federal court
If the FDA offers a deal in regards to a dropped appeal that would (unless the FDA offers an ironclad contract which they do not have to go through FDA appeals before they dispute it) it would mean dropping a concrete advantage in exchange for taking the FDA at their word.
Taking the FDA at their word... is sort of like taking Hitler at his word that he would have no more territorial claims in Europe following the Sudtenland.