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vtem01

04/01/20 1:58 AM

#259415 RE: rafunrafun #259411

RAF,

Why not entice BP or BPs to take an large equity stake + joint marketing agreement, thence fight all the way to appellate court?

With the BP marketing muscles, generic will not be an issue?

circuitcity

04/01/20 2:10 AM

#259416 RE: rafunrafun #259411

I like the third option, does’t GILD have 20b on hand if I remember correct?

I think I asked before whether new generics can enter still, if remember correctly, they can keep come. Unless we set a precedent this time, we didn’t.

Man, the damage is so big and so deep. V was a virgin golden goose, amrn didn’t protect well, now no more virgin.

north40000

04/01/20 2:47 AM

#259421 RE: rafunrafun #259411

Re 3), raf: Does your suggestion not resemble "pay to go away?" Years ago in my career I was deposed by FTC in a antitrust/unfair competition matter involving a drug far less important than Vascepa to the nation's health. Some generics had been paid $$$, or given a license to sell something else. That suit seemed endless...last I heard, it was not finished.

"Ciprofloxacin"?

Sluicebox

04/01/20 5:48 AM

#259433 RE: rafunrafun #259411


1) Inefficiency of the system, obviously not intended to work this way, but serves the purpose of the government wish for cheaper meds. I dont see any one doing anything about this.

2)Normally anything obviously in the field of medicines, need to be backed up by scientific evidence. To the judge the Mori trial could seem as that?.
However would a POSA in this field, normally requiring tons of evidence before concluding anything, see Mori trial as providing this kind of evidence or providing obviousness ?
And I continue to get back to this, IF other companies have started EPA+DHA trials after the Mori trial was published, I think this proves that Mori did not provide any obviousness, as otherwise no one would have started any new trials with EPA+DHA after Mori. BTW The American Journal of Clinical Nutrition, seems to be a publication highly esteemed?

3) BP will buy Amarin cheap and then offer generics money to stay away. Total sum much cheaper than your suggestion.

eightisenough

04/01/20 5:54 AM

#259434 RE: rafunrafun #259411

Hi Rafa--hope you & family doing well and healthy.

Regarding #1--you're right its not fair from a moral point of view--but business wise its no different than off label--that we all advocated for AMRN.

Regarding #2: Judge is using fact that : "DHA increased LDL cholesterol by 8% (P = 0.019)." (https://academic.oup.com/ajcn/article/71/5/1085/4729166)--while EPA didn't. Your arguments about population size was made by AMRN and she disregarded it, based on fact women and men are similar (different than rats). The better argument is the sample size had low trig level while Marine study had elevated trig levels which is essential. High trig level' mechanism shows that even pure EPA would have elevated LDL. AMRN argued this at trial--she ignored it.

Regarding #3: I like you creative idea , but I think you need to increase the payout to generics about 2 B each which leaves us with half the sp of $12. Would you take $12? I would.

rdhitchcock

04/01/20 7:44 AM

#259450 RE: rafunrafun #259411

One thing that took me by surprise was in Amarin's arguments. They spoke about statins lowering triglycerides which is obvious. However they pointed out this was only indicated for patients with triglycerides under 500. They pointed out that some patients that received Lipitor with triglycerides over 500 had the exact opposite reaction and had dramatic "increases" in triglycerides, so much so that if I recall correctly from what I read, that this was indicated on a label for Lipitor.

If this is true, I am puzzled how the judge can use this one small study of 19 men only with none of them having triglycerides over 250 and applying it to all patients with triglycerides over 500 saying that it was obvious.

Larrybirdlegend

04/01/20 10:40 AM

#259570 RE: rafunrafun #259411

RAF
1 agree
2 agree lousy ruling. (But while Mori was the driving force it wasn’t the only factor). Burden of appeal standard is very high bar. Overall appeal success rate is less than 7%. I agree lousy rule but even if odds of win are 20 or 30% that’s still a long shot. Someone here said “let’s see how good their attorneys are”. Well, Covington is akin to the Yankees in baseball or Alabama football. The best there is. But they lost already! To think they have a better chance of winning in appeal those are even longer odds!

Appeal is right action but I URGE everyone it’s a long shot. Temper expectations and plan accordingly.

3. So brings me to your last point. Explore M&A options. First, I preface this by saying I hate that I’m even in this mindset now. I was always a fan of Gia but circumstances have changed and I do not want business as usual while litigating and then lose effectively giving generics the market.

So that’s what brings me to your point #3. I’m in agreement this option is really the only option left.

North4000 brings up a good point about paying generics walk away $. But that’s why time is critical here. If BO happens fast the acquiring BP can offer terms or royalties, (creative legalize) to do exactly as you say. It may not be as cut & dry as “here take $1billion now walk” but I made my point.

The BO explore is really the only option left.

Amrn could go to BP and say we will sell Europe/ RoW and we keep US but losing proposition on 2 fronts.

1. If Amrn loses litigation =game over
2. BP sees US as “sour cherry scenario”. Makes sense to have it, litigate and if they can turn it great if not tax write off.

JT now lost leverage. He needs to come to terms with it. I feel his pain. Like him I’ve wanted to grow this into BP. I was a fan of JT. I supported him. When all the backseat CEOs criticized I still held confidence but that’s gone now.

There’s no point playing the “what if game”. What’s done is done. This is time to strap up the boots and move forward.

I expect option 3 to be in play. If not, then I do not plan to sit here and watch litigation unfold with my $ on the line. I’m 10 years in this and I’m still in the green. It’s a bitter pill for me to be ready to walk away but I’m realistic fighting a fight with 7% odds is not logical. They need clarity on these facts.

I challenge anyone here to tell me I’m wrong. Tell me the appeal is 90% win and I’ll listen but it’s not. Everyone knows appeal is even harder than Reno.

Amrn has no leverage, no time, not enough capital power to deal w Reddy, Hikma, Teva but an acquiring BP does.

An acquiring BP can get Europe RoW and make $ and then unravel the complicated web of the US..

I hope someone can reply and prove to me that appeal odds are closer to 90%. I’d love to be wrong but even if it’s 30% success that’s a steep gamble for Amrn to bet on

Option #3 is really only option left. As CEO JT has a fiduciary duty to do what’s right, principles aside, he’s indebted to all of us, all shareholders from Baker Brothers to the little guy, he needs to act and act fast.

His next move is the most important for this company! Here’s to option #3!

james murphy

04/01/20 11:35 AM

#259618 RE: rafunrafun #259411

Raf can we as shareholders or amarin sue the patent office for giving us a patent that was invalid and caused amrn to then go and spend 300m on a 5 year trial but it was all bullshit cecause the patent office fcuked up

biotechtrader2020

04/01/20 3:17 PM

#259829 RE: rafunrafun #259411

1) How is generics selling Generic Vascepa for RI indication, after invalidating a MARINE (not RI) patent, does not make a complete mockery out of the legal / regulatory system?
Drug companies have been making a mockery out of this system for years by extending life of patents. unfortunately amarin is receiving the wrong end of the stick in this case.

Doctors will write a prescription for vascepa. Insurers and pharmacists, who don't have insights into the patient's triglyceride level will substitute this with generics. The patient walks away paying just a few dollars for generic vascepa. As an investor you lose and the patient wins - the sooner you wake up to this new reality, the better it is.


2)Completely different population, of 19 men?!
If they had included women, you would have complained about not having transgendered participants. If they were included too, we can always include these additional genders to whine about and cry foul:
https://dudeasks.com/how-many-genders-are-there-in-2020/

The issue is not whether it was open label or whether it was peer reviewed.
Amarin filed for 20+ patents with a study of 229 participants (4g,2g or placebo) and Mori (4g epa, dha or olive oil) did a study on 59 participants.

Mori's conclusion - EPA did not impact LDL but decreased HDL (JL pointed out that back then it was believed that decreased HDL adversely impacts cardiovascular risk).

Judge Du is claiming that someone with ordinary skill in the art can read mori's paper and come to the conclusion that EPA is beneficial as described in Amarin's patent.


Reality check: We (including myself) have confirmation bias. We are in the denial stage where we are refusing to admit that this could have happened to us.

But here is a silver lining in the denial. This has turned raf from a guy who was insensitive to the plight of hundreds of thousands of coronavirus patients to a champion of woman's rights. I have to thank Honorable judge Du for that.



3)BP buys us at a 50% discount ($10B)

Management's current plan:
1. Litigate for 2 more years
2. Dilute share count and give millions in share grants to execs and do periodic insider sales.
3. Diligently burn shareholder value.

BP will buy us in a firesale at a fraction of that price or will walk away as the generics take over and this management burns shareholder value.