Agree, but contents of the transcript would be more real!

If anyone has access to the hearing transcript, can it be shared please. Or at least throw some summary - Thanks!

me too always watching and reading every single post here. I always believe justice will prevail and is for Amarin and us this July 10th. Janet & her company are ultimately getting punished for all the criminal work they did - we have been thru a lot of pain thou.

she is a vicious woman

The Senate should get her this time. She made a mockery of them and showed her middle finger last time.

So, could be Woodcock doing all these things; Hamburg a scapegoat??

Someone should write a speculative SA article basing the court transcript listing some of those pages favoring Amarin. He/she should point out that an appeal proof verdict might be on its way as that might take a longer time to write right.

If Anchor approved shortly, will V get at least a NME from the approval date? If so, does it mean those generic filers lose their chance of making generic V for at least another 3 yrs or so? Does any one on the board think a compromise is being worked out between Amarin and FDA and the Judge is holding on his decision till then? any thoughts??

BB, any update on the Investors vs Amarin court proceedings? thanks

Yes someone should write a SA article or so on this 2015 NLA guidelines. In fact they referred all the sub group analyses from the 3 studies FDA Adcom used. Also referred is the Jellis subgroup recommending EPA therapy.

Or some analyst should refer these 2015 NLA guidelines to upgrade the Target price of AMRN.

why all on a sudden? Does it mean they got the expanded Anchor label? spending money on sales force?? weird

The underlying question is whether V benefits mankind? FDA is supposed to quickly bring drugs to help the mankind. It should not just act on the Tg thesis or based on the other Tg lowering drug results or pick up one of the million reasons to screw it over. FDA knows what V can do but they are colluding with Wallstreet crooks to kill this company as they did with DNDN.

You are correct! Just to screw over Amarin - it is more retaliation. As we are seeing that generics are not cheaper than V either. Somebody has to do something - could be Judge Moss! All we can cling on to is Justice. It will come even if Moss is not righting this mess.

What is this? Other than Amarin lawyers, are there none in this world who can do something on this imperial FDA? In the name of regulating the drug industry, how they can be allowed to do whatever they want twisting the Regs they themselves wrote interpreting in their own way when they chose to. I guess one time Biobill said FDA now thinks that Amarin is trying to use the FDA system to materialize EPA, a common ingredient available in the nature for their richness. But Amarin identified and isolated this EPA as V, who else did it, and they have patents and they signed SPAs with FDA. Amarin lawyers should ask for monetary damages from FDA. With all the science and evidences mounting, when is FDA going to let the people benefit out of this wonder drug.

I guess he meant 8 - 10 gms worth of EPA and DHA together from DS intake. This might mean intake of 4gms of EPA alone that V should be meeting this requirement.

may be Anchor Approval is coming soon!

is Hamburg gone by today?

I too like JL's bent ace analogy. I'm soo glad now it is Amarin's turn to return the favor to FDA from both back and front.

Yes, now the NCE hearing caught the FDA. The patents from the USPTO and this hearing are the blessings in disguise for the Amarin shareholders. If there was still no hearing, FDA will continue to play its delay and uncertainity tactics on Amarin for ever. Not anymore and this Judge is a No Nonsense Judge for sure!

I'm speculating that FDA will release Anchor results this week. This week is the last week for Hamburg. No one else would want to deal with this mess created during her time.

It is connected. We will get everything: Anchor, Reduce-it, BO etc. Joe Z is a great chemical engineer; did a super mass transfer process to isolate EPA, built a good patent fortress. This is a wonder drug. I guess I just want to be more patience.

I thought someone higher up at GSK was asked to go. May be wrong.

not only that; FDA flood the market with generics and supplements. FDA thinks they are super power with all the authority. No wonder the judge doesn't like it.

Yes, AZN was going to buy. GSK influenced Reinnaisance to stop it. Now both GSK CEO and Hamburg lose their jobs.

HHS Sec might have already instructed to clean all the mess Hamburg created before she leaves month end. We should see Anchor by then. What happen to the 11000 put before Adcom. who did it.

Is the court hearing finally over? How long it took? Any update??

I think AZN is conducting similar comparative studies too. AZN really knows the anti inflamatory benefit.

No, read SunTrust update; also check Bangtime posts

Yes it might happen this evening AHrs. Amarin management told Suntrust analyst that they are in active discussions with the FDA.

When FDA approves supplements, FDA knows supplements doesn't have the right strength of EPA and it has the DHA etc which are no good FDA knows. What does it mean? I bet Anchor is going to be approved too.

Looks like no leak from the conference attendees or Cherry presenters yet but we will know COB today. Thanks

Any updates from the conference on the Cherry study yet? I saw V is called Liquid Stint! Is it from the Cherry study?

what came down must go up too and that is what happening. It need to go up to at the least $20/share.

no wonder they phrased the voting question that way: should we approve now or not?

Really a Good idea and a well timed article if someone writes it out.

yes, I see that! FDA is not chartered to care about this either whether a company gets its patents approved or not. Luckily USPTO stands God for Amarin and the patents it approved to Amarin will hold to prevent generic entry for sure. And R-It with a >50% efficacy is a given!

No one would believe this - How does FDA wants Amarin to finish R-It and at the same time kill NCE to flood generics before the completion date?

Amarin should have got NCE based on the then policy: EPA as the active moiety and for Lovaza the entire mixture was the active moiety then. FDA is playing games interpreting EPA was part of the mixture and so NME for Vascepa. If Amarin applies for NCE now, it will get NCE now based on the current policy. So, don't you think the Judge wonders what is wrong with FDA here.

You are right and we are all including Amarin is betting on its patents and AZN not launching Epanova is a proof but Wallstreet pretends and doesn't give that mauch value to it yet. I was frustrated on FDA's criminal behavior on Amarin. At the same time I remember someone in the past wrote that there is a God for Amarin and he meant US Patent Office and now I just wonder how true it is. Had the patents not there, FDA could have already finished Amarin.

Correct. Amarin should at least explain this to the shareholders in this coming CC on have they ever asked FDA how it justifies its rational for urging Amarin to complete R-it which could take up to 2018 and at the same time willing to accept generic filers now? What non sense is this??