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mrmainstreet

08/31/15 8:55 PM

#58106 RE: Whalatane #58094

Kiwi, you're using the same tired "logic" you posted when arguing that Amarin had made a mistake fighting for 1A rights, and you're wrong again here.

There are no Pro Bowl goverment attorneys waiting in the wings to save the day, but just more of the same middling talent. You think with all the coverage this case has received that FDA rolled out the bench players? You are grasping at straws again to try and be contrary, but even for you this is weak sauce.

Read the judges opinion again and you might gain some insight. JMO, but the FDA is on their heels and the only way Amarin agreed to "settlement talks" is if something very good was offered. If the FDA appeals they are just digging the hole deeper and creating a more powerful precedent.

That last post was pretty sad compared to your other soft bashes of much more skill.

jessellivermore

09/01/15 6:04 AM

#58127 RE: Whalatane #58094

Kiwi...

C'mon man..." If we can't settle this on terms that work for us ...we will appeal every decision and fight it out with our best legal talent until the bitter end .
After all our legal budget is practically unlimited ."

Kiwi is this really all you can come up with.. truly pathetic..

Hello!! The FDA already has two strikes against them..Caronia and the Amarin initial PI decision...maybe the FDA should have been trotting the first team out a little earlier in the game..They are down nine runs with two out in the ninth and two strikes and you think they are going to pinch hit. Who will they hire??? Floyd Abrams??

The FDA will appeal nothing. FDA understands the risk reward in this situation, even if you don't. Stop trying to blow smoke up my ass off with your war stories. You don't need a hundred lawsuits to understand settlements. The fact you have been in a hundred lawsuits may indicate you don't understand settlements.

JMO having listened to more BS artists than I care to remember.

":>) JL

zumantu

09/01/15 8:18 AM

#58138 RE: Whalatane #58094

Kiwi, the weakness in your reasoning is this - Amarin already won - they don't "think" they will win, the judge already made it clear the permanent ruling will be. Therefore the "floor is in... If you accept my assertion as a fact ( and I cant understand how you cant ) then by default, Amarin must receive something materially greater than they have already been awarded - Since Amarin was granted the right to promote Anchor indication as off label - then even an FDA appeal is moot because marketing and script revenue and the financial befit realized continues regardless. So why appeal? to punish Amarin? to seek leverage in settlement talks- that tactic would be laughed out of the room by Amarin attorney's

From a practical perspective, all that's missing is insurance coverage - so how can Amarin get insurance coverage? We all know the answer to that

What would the FDA get? We all know that answer as well

So what we don't know is all the permeations of settlement possibilities - all of which are "additive" to both parties - otherwise there would be no settlement talks

I will go out on a limb and suggest your personal history of litigation in the construction industry is likely not an appropriate yardstick to predict a settlement outcome in this case. And while I would agree that willingness to settle (in your context) would be seen as a sign of weakness that is NOT the case here- Amarin has been materially harmed and now, for the 1st time, the FDA is now facing it's own harmful consequences of losing. Far different than Amarin's monetary consequences, but consequences nonetheless.

In summary I cant see how any of your hundreds of cases apply here (terrible business model BTW). Your allowing a narrowed personal bias ( win- lose) color the obvious.

Amarin is facing down a regulatory agency with largely unlimited power. They seek not a financial settlement, but a regulatory one. the potential outcomes are not one loses and the other wins. The very fact a settlement discussion is occurring is because of the possibility of a win- win - not a win- lose.


This 1A move is more like "MAD" policy during the cold war - we took a direct hit at the ADCOM but we finally have a few nukes of our own ready to launch..

Mutual Assured Destruction - come and get it FDA, our finger is on the button- or we can elect to live and let live ....


Think man

sts66

09/01/15 2:17 PM

#58188 RE: Whalatane #58094

Appears you think the FDA has all the power here? Did you forget that they were the loser in court, not the winner? And that by appealing they risk making the AMRN specific PI become law for all drugs?

yellow_bluff

09/01/15 3:25 PM

#58203 RE: Whalatane #58094

FDA has no legal talent. They didnt appeal NCE and wont 1A.

Read the transcripts from NCE and 1A. All FDA has is its inherent power to approve drugs. Otherwise they are an empty suit. I cringed when I read what FDA said in both suits.

NCE - FDA had to ask AMRN counsel for citations... cringe

1A - FDA tried to argue V isnt safe... cringe.

Emporer has no clothes and is a fat ugly mofo...