Politicians respond to volume, they want votes. If everyone and all they can get to join call or email their local representatives it might help.

When letter finished can you share. It would be good to flood Feinstein's office with copies esp from those in California

If you saw earlier posts SR is recently employed in some way by Amarin so maybe he knows something or Amarin is trying something.

Thought so thanks

Since working for Amarin maybe he knows something like negotiations with FDA? Was this a very recent prediction?

Isn't that a good sign? The company promoting itself instead of all this doom and gloom being posted everywhere

That was my point. The FDA was shut down, all regular employees were furloughed. This wouldn't have happened during regular business hours. This is my last post allowed today.my email is wmjenkins3938@aol.com

I thought the same thing, all these doctors that never heard of Vascepa will certainly be aware of it now, publicity good, FDA bad guy, and no reps collecting salaries needed.

JL, I think you're saying the same thing I'm saying, the SPA agreement is difficult to break, but the matter of Vascepa helping CV outcomes, that's been decided, no judge would go against that. Evidence in a court case is given by experts,the Adcomm panel is the designated by law expert, you need a preponderance of the evidence to win, judges are not experts.

It never ends, just got email from Mrdscape: Rsising HDL cholesterol, the controversy

That's not true at all about doctors not believing unless on the label. If you listen to video on the link JL sent out on that court case, the ex FDA attorney says FDA too slow and too many requirements, expense, and nonsense to change a label, and off-label necessary to protect public health. All doctors know to follow reputable studies and medical society guidelines, they don't read the label! The FDA doesn't say doesn't believe, it says wants study completed.

I agree the entire defense is breaching SPA. But Amarin can't dispute Adcomm's findings unless fraud was involved. Courts make decisions based on assigned experts, courts can't give their own opinions. Adcomm was assigned to make the decision, that's it, you can be right but it doesn't matter.

And if you read the entire section on breaching a SPA, it's not just new evidence, that would make every SPA too risky, it's meant to protect the public, the new evidence must demonstrate a public health concern, not just maybe it might not work with a harmless drug.

I wouldn't think for legal reasons, anyone could take the audio recording and hire a court reporter to make an legally enforceable transcript.

Plus if this allow off-label promotion takes off now that it seems FDA cannot stop it, these multitude of Vascepa benefits prescribing can take off without waiting for snail-pace unpredictable FDA approvals.

I agree with you totally,but we also have to deal with a government with unlimited legal resources and a small company. We should probably know the answers at the CC when Amarin's lawyers have had time to digest the problem and possibly have talked to the FDA. Big question still remains, why did FDA ask the question?

But what do you guys think about the FDA is using the Adcomm to provide cover to keep prevent CV events off label but will allow reduce trigs on label, thus allowing SPA as maybe originally written but skirting the controversial CV event matter?

What day is CC?

But then why did FDA convene an Adcomm and ask the question? Now they have an answer from their selected experts.

I think that's a good idea, these Citizen Petitions the FDA pays attention to and have effect. If anyone needs help let me know but I believe you need in person signatures.

California too, Amarin can advertise Anchor despite FDA
http://www.martindale.com/EmailListing.aspx?Link=http://www.martindale.com/pharmaceuticals/article_Cadwalader-Wickersham-Taft-LLP_1725718.htm

Amgen did not fight the FDA before it could use the decision in its defense

Is anyone doing a citizen petition per FDA guidelines and CFR Title 21, Volume 1, Part 10-B section 10.30? The rules are very specific including getting signatures in person.

You are wrong in saying the drug companies are sued by the FDA civilly for breaching an agreement and thus the rep's criminal case has little bearing. True the drug company paid a fine because it did not fight the charges. But it did this before the rep won his case. What other drug company has been prosecuted successfully since this case and in which appellate district was it prosecuted?

Wrong,the drug company was prosecuted criminally alongside the rep. You can't put a corporation in jail so it pays a fine. But it is a criminal charge for breaking the law not for breaching an agreement.
And "The American Law Journal" disagrees with you, it is skeptical that the FDA will ever prosecute again for off-label promotion by drug companies. The drug companies feel free to do this now.

It shows Vascepa will be prescribed for trigs under Anchor even if Anchor not approved by FDA, because guidelines say so and only drug available that works without side effects

They make you provide your home address, although promise to keep it secret

So, to make it official you just have to follow the guidelines.

He represents the company, cannot lie. His lawyers would not allow a lie that can be easily checked.

Right can't change FDA label, but why can't advertise off-label benefits as long as not blatant lie?

Sounds plausible, will know more next month at quarterly, FDA should inform Amarin of something, or the lack of any FDA notice might be telling also.

FDA is not omnipotent, courts are!

Wow! Reps can now promote off-label. That was an appellate court so covers large area. Ninth Circuit ruled opposite so not ok in California yet. When appelates disagree the Supreme Court will intervene.

But isn't that all considered in current stock price, a buyout would have to be for more than that?

Can you post a link to that court's decision.

Even if it is a cheap buyout it's an opportunity to make up for losses so far for stockholders.

Good point, anyone else agree?

My insurance pays even though my trigs normal. Anchor would not change anything. Insurance company has no idea what my labs are. Off label very common, most of Lovaza's sales off label. The Adcomm panel suggested off label.

Yes, just doesn't look good.

Where does it say prior to Adcomm?