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1st Amendment Rights - You'll Love this:
(Gotta Love the Defendant List (see the link below):
http://www.gpo.gov/fdsys/pkg/USCOURTS-dcd-1_09-cv-01546
http://ducknetweb.blogspot.com/2010/06/fda-loses-in-court-with-violating-first.html
http://www.emord.com/Emord,%20ANH%20II.pdf
Here is a re-posting of one I put up back in early November...
Post #20065:
FDA gets Sued by a Small Guy and Wins!
Chalk up one for the little guy...
http://ducknetweb.blogspot.com/2010/06/fda-loses-in-court-with-violating-first.html
In our case:
Substitute the Word "Selenium" with "Pure EPA"
Substitute the Word "Cancer" with "Hight Risk CVE Patients"
Someone needs to call this guy: Health freedom attorney Jonathan Emord
Amarin cannot Appeal until they get their 12/20 formal rejection letter. They appealed out of order!
Chabojilo
Thank you for that!
You are like sitting in my brain reading my mind!
That is exactly what I am saying...
I am hopeful we can get the "High Trigs" approval without a target group!
Not sure YET hopeful...
I am confident (in my opinion) that we will not get the FDA to approve Anchor in the way Eric Coleman said was it (in the FDA's opinion) was intended (to reduce Heart Attacks)...
That is what Reduce-It is intended for and that is how the FDA will leave it (again, in my opinion...)
I know a lot of people feel and think differently (wanting it approved as submitted meaning the FDA will do a 180 degree turn) AND I as well will be popping the cork if they are right yet not hopeful of that...
Chabojilo
The mistake Amarin made was to list their "Target Group" in the Anchor application (which they did do...)
I never said they (Amarin) stated or implied in their Marine and/or Anchor applications that they were treating CVE's in ANY post I've ever made...
Everyone who wants to reply to my posts loves to add that statement...
They did not list a target group in Marine - they even have disclaimers saying it has not been proven to reduce CVE's and another to say it has not been proven to reduce Pancreatic Inflammation...
So it you take both of those disclaimers out of the equation of Marine, what on earth is Marine approved to do: Reduce Lipid Panel results which the FDA and even the AdCom Board said Vascepa does a great job doing.
If they did not list their target group in Marine, then why TF list it in Anchor???
To go for a home-run and (due to bad timing of other failures) piss off the FDA!
Well we certain did that...
So now we will go back and ask for a revised approval without the Target Group...
I am 100% for that idea and even Amarin said they were going to request it in the last Conference Call...
DeepBreath
"Set to Fail"...
That is what I refer to as the "Conspiracy Theory"...
It is unfortunately an unending loop of paranoia that never ends with no solution and will never win in an argument with the FDA.
Everyone needs to stay away from that thought - it is a vicious loop that never ends...
Read the FDA AdCom Law Suit attachment link I sent - read each and every case - you will get the essence that the FDA will win in ALL instances...
http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1640343
Click "Download this paper" in the center right hand side...
Some who tried to ram the "Conspiracy Theory" down their throats came very close to saying the FDA was in bed with competitors (Big Pharma).
The FDA does not deny being influenced by comments by Big Pharma - if you read the report in full you will see they are influenced to the right (Big Pharma), then to the left (applicant), then back to the right (Big Pharma) and so on and so forth even changing their approval/rejections over and over on a single product approval request until they get to a point where they hold a final position which is usually their 1st position.
With that said (and what I am saying is) let's find a way to get them to OK Anchor in some modified form that does not match their rejection...
They win and we win...
wmjenkins3938 - Just emailed to you...
DeepBreath - Incorrect...
Amarin noted their intended target group in their application.
That is and only is the issue with the FDA and what I am saying.
Eliminate the Intended Target Group from the Application and get Anchor approved to treat people with HIGH Trigs to go along with the Marine approval treating people with VERY HIGH Trigs...
Again: Someone will reply to this with:
"You have to have an intended target group or you will not get an approval."
Chabojilo;
You are 100% correct YET the essence of this board on many fronts is that Vascepa should be approved "exactly" as Eric Coleman stated in his opening statement (to reduce heart Attacks) and that simply is not going to happen!
I noted a few times that I spoke to Joe Bruno of Amarin and asked him why Amarin listed similar language (to that of Coleman's) in their application and he said: "Because it is normal to list your intended target group"...
Now I will get a reply to this saying: "You have to list an intended target group or you will not get an approval."
...which I disagree with when the short term goal is to help people reduce lipid panel results.
The ultimate goal is to prove that such reductions reduces CVE's and that the Reduce-It trial...
RSQUIRREL: EXCELLENT FIND!
ERIC COLEMAN ADCOM STATEMENT THAT DESTROYED AMARIN FROM THE VERY BEGINNING:
This is the single line at the opening of AdCom that I feel destroyed Amarin chances of gaining the "extension of Marine" (remember: Marine was ONLY to treat Very High Trigs...)
Dancing in the dark - Exactly yet at this point what else can we hope for...
Chabojilo - And this is the exact argument Amarin is taking up with the FDA in their appeal!
Cannot see how they can lose unless the FDA states that Treating Trigs in the 150 to 499 class is not necessary.
Let's see them choke out those words!
north40000 - Yes it can...
Amarin said in their CC they are going to request that in their Appeal and at the Type "A" meeting...
JohnKing29
Chabojilo : You seem to be the only person I completely agree with!
That is what Amarin said they were going to drive home over the next few weeks and/or months with the FDA!
I do not see how they can lose YET if the FDA is out to nail Amarin, they (the FDA) are going to have to get creative!
The issue is black and white!
I think (hope like hell) they will approve a modified label matching Marine!
Chabojilo: Well said!
Dancing:
...and that is my very point.
Force the FDA's hand to say: "Reducing Trigs in the 150 to 499 class is not necessary" by submitting a revised Application requesting the same.
Dancing in the dark : They already proved Vascepa reduces Trigs in ALL classes (High and Very High)...
...and if you are correct then why is Amarin currently stating they never intended to have Vascepa in the Anchor class reduce CVE's?
Not sure what you are saying yet what I am saying is the FDA OK'd Vascepa as a Trig reducing drug only in Marine.
Nothing more and nothing less...
They even state in Marine that Vascepa has not been proven or tested to reduce Inflammation of the Pancreas which is the only known purpose of Trig reduction that the FDA really cares about... The FDA even said that at AdCom.
So if the FDA approved Marine with the CVE and Inflammation disclaimers then why-TF did they approve Marine?
Who was the target class???
The same target class that Anchor is shooting for: People with elevated Trigs above an acceptable level of less than 100...
mp15shoot: Thank you for the positive reply!
IF the FDA does not approve this updated Application then Amarin has a HUGE advantage on them in a fight knowing Trig reduction is important (and the FDA cannot deny that!!!)
It was obvious that the Board felt it was an excellent product to reduce Trig's!
There was never talk about a modified label noting that the drug has not been proven to reduce CVE's.
Amarin's ONLY goal was to get an OK to market the drug in the 199 to 499 class to make a lot more money.
The FDA has ZERO proof to date that lowering trig's reduces CVE's...
OK then - we get it!
Then approve us to reduce Trigs in the 199 to 499 class and let's get on with it!
Biobillionair - And Thank you for ALL you are doing! You have many steps on me in this department...
I did list in a previous post an Attorney's name who beat the FDA...
Not sure if this helps - Here is the original article:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=93601548
Again Thank you for everything!
sts66 - You may be correct IF Amarin stays the original course that the FDA thought they were (incorrectly) taking with Anchor stating they are Lowering Trig's to reduce or effect CVE's...
They will NEVER get that approval until Reduce-It is done.
They can and will only get a modified Approval of Anchor if they remove the CVE language and list a disclaimer just like they have it in Marine (something to the effect of): "This product has not been proven to reduce CVE's"...
Anchor can and will only be allowed as a "Trig Reducing drug" and not a "Trig reducing drug to assist in reducing CVE's" until Reduce-It proves that it works.
Getting an OK to market to the 199 to 499 class is important and has always been the ONLY goal of Amarin (according to Amarin) as Amarin said in the recent CC (in more or less words): "Anchor was not created to benefit those with CVE's. Anchor was created to Lower Trig's only."
ziploc_1 They are also saying that they are not going to keep allowing applications for products with specific Target Groups with treatments that have no proven to work.
The FDA ONLY said: Reducing Trigs has not proven to reduce CVE's.
I have to ask this question: If you are the FDA how many more applications do you accept that say: "We are going to reduce Trigs and Reduce CVE's?"
So you get rid of the CVE part, get the extension of Marine (like we all thought this was going to be - reducing Trigs in the 199 to 49 group with NO TARGET GROUP - IE: CVE Risk people), and move on with the allowance of Trig Reduction in the 199 to 499 class which one board member said works extremely well (Vascepa being a Trig reduction product!)
All of this conspiracy theory stuff will ONLY be proven if the above revised application is rejected (in my opinion.)
Otherwise the FDA is not wrong saying: We are not going to allow yet another drug come along that states they will reduce Trigs and in effect Reduce CVE's.
That is ALL they said!
Unfortunately the AdCom meeting is/was not an opportunity to question what Amarin apparently feels is a mis-direction of the FDA whether intentional (conspiracy theory) or unintentional (mis-reading the Application)...
Amarin said in the CC that they are going to request this modification with the FDA.
HOW CAN THE FDA SAY NO!?!
If they do I am joining the Conspiracy Team!
Mexinv: Amarins Marine indication mentions nothing of CVE's other than to take the very exception you note and that is that the product has not been proven to positively effect people with CVE's...
The Anchor Application mentions "treating people at risk for CVE's"...
If they did not include the quoted line above then we would not be having this conversation and Anchor would have been approved.
I asked Joe Bruno (Amarin's PR guy) why they did that and he said: "It is common that you list the target group in your application."
FDA read it as though Amarin's only goal was to treat people with CVE's... After-all (why not! - I say with the same regret as Amarin), that is their ultimate goal...
YET Amarin is now stating "that was not what we meant!"
Amarin (in my opinion) will get an Approval for Anchor deleting the noted target group and adding the same exception as Marine to the label (...This product is not known to help people with CVE's.)
In the end: The FDA win's the fight yet we win the war!
Problem: It is NOT going to bring the Stock price back up to double digits until:
1. We see a huge increase in sales effecting the Stock price.
2. We get Positive Results from Reduce-It.
3. We use the money earned in #1 above to do additional tests showing the added benefits of Vascepa.
JohnKing29
Labner: Can you email or fax that info over to Amarin? I do not trust they have everything we find...
Labner: Reading this is unbelievable...
They clearly state in their language that their target group are people at risk for CVE's!
It is as though "Food Grade" is not as important as "Prescription Grade" towards the Health of people with CV Risk.
If that is the case then why are they so focused on Trans Fat?
Doesn't the DHA in this product concern the FDA?
I have to remind myself that the FDA (incorrectly) focused on one part of Vascepa only: Does the Reduction of Trig's Lower the Risk of CVE's!
We will win approval of Anchor in a modified version!
Greymatter1:
To carry on and reinforce my previous point:
This is from Goldman recently...
I highlighted what I've been saying since day #1:
Goldman's comments on FDA (11/8/13 report):
Greymatter1: I am not speaking on chances or previous positive or negative outcomes of Type "A" meetings yet am just as curious as you...
You note in your opening sentence a concern about "Marine"...
Did you mean Anchor? Anchor is what was recently rejected...
My opinion since day #1 following AdCom has been:
Marine has a disclaimer that goes something like this:
"This product has not been proven to reduce CVE's"...
My contention from day #1 is that AdCom's only argument is Vascepa cannot say "It reduces CVE's"...
The FDA never argued anything else except to say, state, and imply that Reducing Trigs has not been proven to reduce CVE's...
My take has always been:
1. The FDA has focused ONLY on Trig Reduction reducing CVE's... That is NOT what Vascepa is only about...
2. Amarin should never had noted their target group in the Application... IE: People at Risk for CVE's...
3. They should ask for a Modified Approval stating the very same that Marine states: "Vascepa has not been proven to reduce CVE's"...
In effect you let the FDA win and we win by getting the ONLY thing we wanted and that is an Approval of Anchor.
Anyone who thinks we will get an Approval of Anchor with the language in the application stating the target group (people at Risk of CVE's) may as well pack it in...
That is NOT going to happen...
I think the FDA became very focused on that part of the Application and with two recent failures of completely different drugs, the FDA became very, very narrowly focused and closed the door (again on the concern that they thought Amarin's only goal was to treat people in the 199 to 499 class with the only goal of Reducing Trig's to then be able to state that they were treating people CVE's...) The FDA said NO! I do not believe we can or will argue that position of the FDA... After-all: No one has yet proven that a Reduction in Trig's will reduce CVE's!
NOTE: I do believe Vascepa WILL prove a reduction in CVE's yet not only thru a reduction of Trig's yet in conjunction with ALL of the other positive properties it has!
I think all of this Conspiracy Theory stuff is made up by everyone on this board.
NOW: If Amarin asks for a revised Approval with the disclaimer and the FDA says "NO", then I will be in complete agreement with the Conspiracy Theorists!
The FDA never said or stated any other portion of the Product is bad or will not work or does not do very positive things to people's Lipid Panel results...
The FDA rejected one of the Panelists suggestions of a modified label saying something to the effect that if the Product fails to reduce CVE's in Reduce-It, then Amarin will have to change their label... The FDA said that is not going to happen...
No one said how about a Label disclaimer TO MATCH THE MARINE LABEL THAT STATES: "THIS PRODUCT HAS NOT BEEN PROVEN TO REDUCE CVE'S."
This suggestion was mentioned by Amarin on the Conference Call as an option verbatim. They further said "if the FDA thought we were out to claim a Reduction in CVE's then the FDA was confused..."
In closing:
The ONLY problem the FDA has with Anchor is they do not want Amarin to claim that Vascepa reduces CVE's until Reduce-It proves it does...
So what is the next best thing: Approve Vascepa to treat people in the 199 to 499 class with the disclaimer!
I believe this will be approved and if it is not, the FDA is out to get Amarin (in my opinion...)
James Murphy: The FDA interpreted the Application to say that Amarin was treating people who had a high risk of CVE's which in my opinion means the very same as "Treating people with CVE's"...
I've said from day #1 (post Adcom) that the FDA said you cannot Treat people with Amarin to Reduce CVE's (read my statement above again if this confuses anyone...)
Amarin is now saying:
"We never said we would treat people with CVE's..."
I beg to differ - the Application can be read two ways and the FDA read it the way they felt was safest - You cannot state, imply, and/or infer that you are Treating people with CVE's.
Now:
Let's get a modified Approval with the Disclaimer that it has not been proven to Reduce CVE's (just like the Marine approval) and let Dr's prescribe it just like the AHA wants: Reduce Trigs in the 199 to 499 class to 35,000,000 people.
In my opinion it is 100% the same as a full Anchor approval...
We all Know: No Trig Reduction medication reduces CVE's...
Let the FDA have it's way then!!!
In effect you are right (the FDA will not allow Anchor approved as written) and I am right (they need to go for the Approval with the clear exception noted above.)
My Goal: Sell to 35,000,000 and not just 5,000,000!
JAMES MURPHY: Google FDA Lawsuit... Read for a while then kill the rhetoric.
JESSE: I 100% Agree! Got that from your 1st Post!
Jesse: What aren't they going to do and who are they?
Not sure who and what point you are referring to...
JESSE: They are going to use Reduce-It for leverage against the FDA to get Anchor in some form approved!
Excellent move!
Asking FDA for a Modified Label in Anchor:
Noting: This Drug has not been proven to Reduce CVE's!
Exactly what I've been saying since Adcom!
Feels good to hear that they NEVER had an Intention of saying or implying that Anchor would Reduce CVE's as the FDA contends!
I am hopeful they will get an Approval with the Exception noted!
HOW CAN THE FDA SAY NO TO THAT!!!
Gets them the Cash to complete Reduce-It that the FDA wants done as well!
Said they were going to use Reduce-It as a tool against the FDA by saying without some form of Anchor, they probably cannot fund it!
GREAT NEWS as far as I am concerned!
FDA CNN Article today: The FDA is worried still about CVE's!
Amazing!
http://www.cnn.com/2013/11/07/health/fda-trans-fats/index.html?hpt=hp_t2
67Stang: I own a 1992 Limited Edition with 8000 miles on it - never saw weather of any type...
Amarin went for the Home Run on the Label YET that process used to be OK with the FDA... "Used to be" meaning just before Amarin did it!
Joe Bruno of Amarin told me: "It is not unusual for Companies to list their target group in their application."
We all have to remember the Amarin "creed" if you will:
VascepaMiracleDrug: Thank you again!
Great Post Jesse!
mrmainstreet: I have only had two or three positive replies to this concept...
Everyone wants to slaughter the FDA or beat up Joe...
(NOTE: I do believe we have an argument with the FDA on how they handled everything and feel we can win...)
I've said we should request the modified application/label since AdCom: Delete the Target group and get the approval.
Marine was approved to treat Inflammation of the Pancreas even thought their label states that it is not proven to Treat Inflammation of the Pancreas.
The FDA said the very opposite out loud at Adcom when they were asked about the safety of Vascepa. They said: "It is approved to treat people in the Very High Class which treats Inflammation of the Pancreas..."
The Marine label says the same about not Treating CVE's...
Right off of the Vascepa Website:
http://www.vascepa.com/
STS66: I did not use the Phrase: Treating CVE's...
You added that...
Take that out of the sentence and let me know your thoughts...
What I keep saying is Amarin needs to get a modifed Approval of Anchor to treat people in the 199 to 499 class without making claims to any particular Medical Issue...
Labner:
Call and ask for Joe Bruno at Amarin North Jersey - he will pick up or return your call... He is their PR guy...
He returned my call last week within 10 minutes of me leaving a VM.
I suspect they will not allow our questions! It appears that the CC people asking the questions are always the same - people they know will not ask the difficult questions!
It would be nice to have them say yet I highly doubt it!
They owe it to us though!
Labner: I called and left the guy a similar message... Gave him my cell and told him he should start by reviewing this board to get the gist of where our anger is geared towards...
I think the only goal we have in suing the FDA is to get a Judge to decide that the FDA overstepped its bounds using the terms "Efficacy" and "Scientific Information" (which is and was their only out in our case...)
I do not think you can sue the FDA for damages which is the only way an Attorney would take a case lets say on a Contingency Basis for shareholders...
If there is a suit against the FDA it will have to be after all forms of recourse and/or Appeals are exhausted as directed in the SPA agreement and will probably have to be generated by Amarin or possibly by the shareholders YET at the Shareholders expense...
Otherwise how will a Law Firm make money to cover their costs...