There's lots of inflammation and bacteria involved in psoriasis, a drug that limits inflammation would benefit the patient's symptoms.

That's why I asked if anyone can actually get the SEC to investigate, maybe multiple complaints or someone with clout

Congressman Harris says he can't respond to non-residents but I live in California and get emails from him looking for campaign contributions. He will particularly respond to any physicians that contact him.

Does anyone know how to get the SEC to investigate, even a hint of a scandal would be in Amarin's favor against FDA

I agree, I don't want to lose my Vascepa that I use as a patient, but it's convincing the ones that pay the bills. I will email or write to my local representatives in Congress that include Diane Feinstein. Also to Congressman Andy Harris, M.D., from Maryland, he seems to be very approachable and might understand better. I don't feel like feeding politicians a bunch of scientific data, any suggestions or letter I could just pretty much copy?

Fool also says "hefty buyout premium," by GSK

You might be correct about the malpractice, the lawyers and upper-level supervisors were probably furloughed

There was also a panelist that mentioned the costs of Vascepa if labeled for the large trig group. I think there is a directive associated with Obamacare to reduce costs.

I signed it but it's not in the proscribed format so won't the FDA just can and will ignore?

Important point is if FDA seemed to be orchestrating the negative vote as with Vascepa, or promoting or neutral.

It doesn't matter if they don't care if you're saying the science didn't change, it was already changed when agreement made.

So if the entire trig pharmaceutical industry is depending on Reduce-It how can the FDA stop it by denying Anchor? Or maybe nobody wants an answer

Not really, if Reduce-It fails there will still be medical society recommendations to reduce trigs, if on label much easier to get prescription and insurance.

That doesn't sound anecdotal, FMD improvement is CV effect not just lipid lab improvement. Any studies with Vascepa will transfer over to EPA products also.

I would also add the preceding sentence to new scientific evidence, that says public health has to be in jeopardy, that's the real purpose in allowing breaching a spa

That's good, anyone of the panelists can be subpoenaed to testify, if one changes mind on deposition or in court devastating to Mary. Anyone think Mary new and got this by with FDA being shut down and no one looking over her shoulder?

Synonyms

So this is a subgroup analysis from Anchor data. Was this info discussed at Adcomm and do we know if FDA even aware of this analyses? There are other guidelines that recommend treating lower trigs also. That would be fantastic if this included on label, lots of diabetics these days and off label would be promoted greatly.

And I suppose not available to public? That might be very important if the majority expressed reservations and wanted a different question or just went for the off label alternative.

Was the rationale part of the answer expressed publicly on tape or written?

As I understand if there is suspicion Afro-Americans react differently they test them separately, there wouldn't be enough in an average test to be significant if they did find differences

I would think FDA would change its guidelines, rules, or the law before they move the goalposts and breach a SPA, especially since apparently they never or very rarely breach a SPA, and for study design like Dr. Hiatt commented. Courts like precedence, warning, and dislike ruinous damages. If they were protecting public health maybe.

Asian-Caucasian is that what they complained about? Where I live Asians are the majority, and in California Caucasians aren't the majority. And now they're studying in Eastern Europe?

Ok sorry, I have heard about discussion on board about Vascepsb being effective for diabetics but I missed how this came up. To put this on a Vascepa label I'm assuming this would have to be part of SPA, current FDA sanctioned studies or at least discussed at Adcomm, not just Amarin showing some recommendations or studies at last minute before PDUFA.

I did not listen to Adcomm but was this effective-for-diabetics discussed during? Where does this come to the FDA's or Panel's awareness. It's not part of SPA?

If you go to Yahoo board someone recently posted Adcomm discussion between Hiatt and FDA. Hiatt asked if Anchor approved and Reduce-It negative would you pull it. FDA responded we would ask Anarin to remove the indication and if they refused we would pursue legal challenge under imminent hazard.

It was just a quick remark at CC by unprepared lawyer saying options, no one currently has said anything about legal action

I should've said concentrations for those

There's lots if drugs sold OTC in lower dosages and prescription higher, e.g., ketoconazole, steroid cremes

I agree, but knowing Joe, Amarin, and its lawyers so far do you think they'll fight the federal government's unlimited resources.

Yes I agree with everything you say, if not company needs a buyout, Lovaza still selling well without Anchor and it's an inferior product

Look at press headlines: "FDA requires Reduce-It"

If they can see that yes, but right now they just see a new expensive drug that might not help in their minds

You might be right, Congress gives the FDA its power, but Obama executes it, Obama might be directing a new policy of trying to not approve meds that run up the price of Obamacare

It's pretty close though, question was best FDA could ask to get no vote from panel

Yes all that makes sense and what is right, but dealing with a federal government with unlimited legal resources, even if fight would drag on for years with no approval until too late. The FDA convened a panel and asked a question to get enough cover and enough controversy to be able to get away with it even if Amarin has better argument

If that was the case I would think the FDA would have asked the Adcomm that question

I thought Anchor was already contingent on Reduce-it being well under way

But that shows insurance still paying for fish oils, off label without Anchor, Vascepa will take over Lovaza eventually

That would be nice, any evidence for that?