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Bio - Not sure if this is an old version yet at the bottom it states you file Form 95 with the US Marshall's office... Sounds quite archaic...
http://www.justice.gov/marshals/foia/Forms/SF%2095.pdf
struftepete1 - Crowd Funding:
I used to have money but Joe took it all!
I am waiting to get it back!
Amarin Site - Slightly Different Wording under the Investor Faq Section:
Look under the 2nd Topic revised late today noted below:
Can you provide an update on the special protocol assessment (SPA) rescission appeal?
http://investor.amarincorp.com/faq.cfm
Dew: From the Amarin site:
Great Trig Video - I am sure most caught this already... I just saw it myself for the 1st time:
http://www.doctoroz.com/episode/fat-your-blood-doctors-never-talk-about
Dancing in the dark: On that note (not that I expect a different answer): Why did the FDA require Amarin put on their Marine label that Vascepa has not been proven to reduce CVE's nor has it been tested or proven to help Inflammation of the Pancreas?
What else is it capable of doing if it has been proven to do nothing?
I (and I am sure we) will take the approval on Anchor any way we can get it!
DeepBreath LMAO!
Ajax133 - I want to believe he just discovered Amarin and am hoping the smarter guys like you find it comical!
100% agreed!
nutsyprofessor: The "Reduction in Risk of CVE's" is NOT part of the Anchor indication...
Anchor is an extension of Marine which is 100% for the Reduction of very High TG's in the 500 to 999 category...
Marine states that Vascepa has not been tested or proven to reduce CVE's right in their literature.
Anchor covers the Lowering of TG's in the High category between 150 and 499.
The only CVE lowering test Amarin is part of right now is Reduce-It which ends somewhere between 2016 and 2018.
This is beginning to get comical (as much as I want to help you!)
sts66 I meant the rise from last week has to do with someone knowing something (nothing to do with the 8-K.)
I am guessing/thinking that the rise last week and the subsequent creation of the 8-K possibly means that news was leaked the end of the week before, PPS rose, and then Amarin created the new 8-K to handle what is ultimately going to be a delay in the sNDA being approved (not approved by 6/14 per the 12-2 8-K).
I think that Amarin knows already (as of Friday the 3rd) that they are getting the SPA re-instated yet they as well know that they sNDA will be approved YET when is still to be determined.
I have ZERO to base that on except the stock move and subsequent 8-K.
As I said before: A "BAD" stock does not go up 10 to 20% unless someone knows something good privately or publically!
nutsyprofessor - They are not glossing over anything... Their (like my) eyes are glossing over reading your posts knowing the points you make are old news.
People are being polite to you because we all need each other on this board.
The problem is you are bringing up OLD comments and OLD issues that you feel are new and need to be addressed.
Those that are the most proficient on this board will not give you the reply you are looking for because they are ions past them.
What you are getting are the 2nd tier people trying to answer and help you and you give them the very same arguments we've read since October 16th.
I agree with your comment regarding the 15th - I am doing the very same myself and have followed this forum for a year now almost daily!
nutsyprofessor: The problem you are running into in this forum is you are new and the issues, comments, statements you are making are items gone over and over and over many times and all have virtually been put to rest.
Unless you post something new like a new 8-K that just popped up on the Amarin site you are in effect asking or forcing people to explain items that have been discussed.
What you should do if it is possible is go back to October 16th in this forum and go thru all Posts since then.
The frustration you are getting is very experienced posters here are attempting to give you the 30 second synopsis and you are coming back with the same "already shot-down counter-points" addressed many times to the point that no one brings them up or asks anymore.
Not being as Technically proficient as the handful of Pro's on the forum (who truly know what they are saying), I've learned to read what they post and not challenge them.
The only people I can challenge are those who are new. I try to (kindly) steer them straight so they stop running into road blocks...
Hope this helps!
AMARIN STATEMENT on JP MORGAN:
From The Street this morning:
http://www.thestreet.com/story/12229020/1/amarin-out-intercept-pharma-in-at-jp-morgan-healthcare-confab.html
See BOLD key sentence (I added BOLDING):
My take:
I personally do not think if there was going to be Negative news, Amarin would have used the word "Significant" knowing it would later reflect on the stock price negatively as Amarin's hard impression of whatever that news may be!
I still believe this is why we saw all of the action last week - someone knows something! No one invests in a "bad company" raising the stock 10% to 20%!
rdhitchcock : Great Post!
Always refreshing to see the stats in plain 2nd grade English!
We can only hope that the FDA see's it the same way!
Thanks for taking the time to write that up!
struftepete1 : The 8-K statement has nothing to do with the SPA.
The 8-K relative to the Bonus Money only has to do with the sNDA.
Here is what you wrote:
epenephrine - I do not think the creator is a Poster on this site...
It is an excellent piece!
Can only hope those responsible at the FDA see it and more so learn from it!
zumantu - Dito! Well said...
struftepete1 - The Bonus money is for the approval of the sNDA for Anchor not the SPA... The FDA said (on December 20th) that they will not address the sNDA next week which means Amarin may get the SPA re-instated YET that does not give the bosses their bonus money.
Again the Bonus money comes when and if the sNDA is approved for Anchor.
When Amarin wrote up the Bonus proposal (early December), it was before the FDA told them that they did not have a time-frame on Anchor (expressed by the FDA on December 20th).
sys66: They already know they are only going to hear on the SPA next week... They already know they are (probably) not going to hear on Anchor next week.
Amarin created the dates before the FDA said the above so to be safe they extended the dates out long enough knowing (hoping) the FDA will probably decide on Anchor before year end 2014.
My guess is they know the SPA will be reinstated and that means there is a high chance that Anchor will be approved YET they are not sure if that will happen before June 30th...
So the SPA reinstatement seems like it will happen...
My other take is this is the very reason why we saw a 25 cent jump last week, sales positions added, and a Buy rating overseas...
I HIGHLY doubt the action from last week was based on the industry climbing on a whole! HIGHLY UNLIKELY! People do not invest in a loser because the rest of the Industry climbed.
Some good news happened last week to make it climb. Next week we will all be wondering who told who what and why did we not hear about it sooner... It is like a broken record with this stock.
Option #2: The FDA says NO to everything next week and they still want to keep the carrot dangling for their Team to give them an incentive to stay on-board.
With everything that has happened since October, I feel it is highly unlikely they will not reinstate the SPA...
Inspirational Article I like to Read when I have any doubt:
http://dietheartnews.com/2013/06/triglycerides-not-cholesterol-is-the-bona-fide-risk-factor-for-coronary-heart-disease/
labner Then the spin will be that since the original deal failed, management changed it again to satisfy their own pockets.
The outcry would be much louder than seeing it now...
Doing it now makes it look like they are not aware of what the FDA will do. At least that is how it appears right now to you and me.
BET ON THIS: THEY ARE DOING IT FOR A REASON!
If they get the SPA reinstated YET they do not get Anchor (next week) and then they change their own goal post, the Investors will go nuts saying they are changing the rules to make sure they get their bonus money...
Either way making the goalpost move announcement sucks YET leaving the outcome aside there are two completely different ways this can go:
1. SPA Re-instated yet no Anchor next week...
Many have said if the SPA is re-instated then Anchor has
to be approved... Gotta give them their bonus! Who cares
when it happens.
2. If the FDA gives them a flat out NO, then we have phase #2
of the fight which is good enough reason for me to give them
the extension of the bonus money...
After all: What else do we have to lose at that point.
I am extremely hopeful that option #1 happens...
And if it does, I could care less if they get paid by June 30th or by December 31st...
I will be thrilled to know the SPA and Anchor are moving ahead!
John
Labner: Today's 8-K Clues???
It was June 30th (not March)... See below...
Not to say March to June to December is acceptable (Hmmm... talking about a Moving Goal Post!)...
The reason may be that Amarin is expecting the FDA to make a partial positive announcement next week on the 15th yet not enough provide the Bonus based on the 8-K wording from last December...
My take (based on this activity today) is they will reinstate the SPA yet not approve Anchor right away.
All hypothetical (yet very interesting):
The Exec's are now saying,
"HEY - We got the FDA to move YET what if the FDA takes another 7 months. You know they take their time! How about extending the deadline to be sure we are rewarded for getting us there!"
Put the pieces together:
I like this concept:
I think Amarin knows the FDA will re-instate the SPA yet withhold the Anchor approval possibly past the June 30th date so to not screw the Exec's for making it happen, they are extending out the Reward!
(I HATE to be the devil's advocate:)
...or are they are preparing for an outright NO and believe they are going to have to fight the FDA so they are extending the offer to keep the team on their toes?
Just thinking that thought hurts!
I'll stay with my 1st idea!
Any thoughts?
Original Proposal/Offer/Agreement:
zumantu I 100% agree with you...
The compromise I hope they approve offers a happy medium for both parties.
I've said since day #1 the fact that Amarin notes in the Anchor application that they treat people at risk for CVE's creates a dilemma for the NEW FDA when they are "changing" how they approve drugs.
The FDA treated Amarin the entire time like they were requesting an approval for treating people at risk for CVE's.
Others have said that Anchor is only an extension of Marine (which is true) so why not just go for the approval of the 200 to 500 class with the very same exceptions take on the Marine label?
Some say they did and others (the FDA) said they didn't...
Amarin even said that at the Post AdCom CC...
Old FDA would have a approved it.
New FDA will not approve it.
Basically the FDA made their point and will now (I hope) approve Anchor with the Marine exceptions!
sts66 - AF said that months ago before AdCom... He was only saying:
If Amarin expects to sell Vascepa stating that it is a CVE reducing Drug, then they MUST complete Reduce-It before it will be approved which basically means that they are one in the same...
That is an old statement from him.
I say they will Reinstate the SPA and allow a Label change treating the 200 to 500 class with the very same disclaimers as Marine: Product has not been prove to reduce CVE's...
Basically what Amarin was going for in the 1st place!
The FDA just piled BOTH Anchor and Reduce-It in the same hat (rejecting it.) That is how AF interpreted their goal (months ago) and how the FDA ultimately decided to reject it.
They made their point - the new FDA will not approve drugs for specific treatments without successfully achieving/proving endpoints.
So what can they approve: Treating Trigs in the 200 to 500 class while keeping Reduce-It on track!
What else can or will the FDA do?
If they reject the whole thing: We all PUKE then Welcome Amarin's Legal Team back to the podium fighting 1st Amendment Rights to add the 200 to 500 class to the label (with the same exceptions as Marine) on their own and as well continue to fight the FDA to change their position...
dmlcento - What is funny is he is listed as one of the Moderators of this Forum! Look at the top of the page...
Rosenman: I know most do not like him YET his confidence mirrors ours...
StockTwits Posts from the past few days (if you care):
Jan. 9 at 12:49 PM stephenrosenman
@Logical95 full approval with label disclosure about reduce it
Jan. 9 at 12:49 PM stephenrosenman
@mydanilo right
Jan. 9 at 12:48 PM stephenrosenman
@Logical95 very good thing
Jan. 9 at 12:26 PM stephenrosenman
$AMRN By not determining NCE, FDA is affording AMRN protection against generics filing...a gimme while not ruling on the controversial topic
Jan. 9 at 12:24 PM stephenrosenman
$AMRN FDA will not consider generic filing until NCE status resolved for AMRN. That means we basically have NCE protection now.
Jan. 9 at 12:23 PM stephenrosenman
$AMRN Remember my post yesterday, so we'll see what transpires soon. Anyway, another new point--FDA confirms no generic until NCE ruling
Jan. 8 at 3:34 PM stephenrosenman
$AMRN Increasing confidence for AMRN being granted Anchor approval within 90 day period, with or without SPA.
Bio: Not sure if this helps:
See line #5 referencing Claim #1:
http://files.shareholder.com/downloads/AMRN/0x0x616621/b2439f0e-75b1-43c4-935b-dde412148dc8/CI-_9333805-v1-Claims_as_allowed_in__775.pdf
sts66 - I am not saying they don't exist. All I am saying is Amarin is not doing a test to show CVE reduction due to Inflammation Reduction.
Should they be?
I think so...
Maybe they will after they generate income from the 200 to 500 class approval I expect them to get next week.
sts66 - Thanks for the reply...
The Inflammation issue is a Jesse target - he feels the Inflammation Reduction characteristics of Vascepa outweigh its' other attributes (IE: Reducing Trigs)...
I am hopeful and confident he is correct!
I am 100% with you on the 200 to 500 class approval - that is ALL they should have gone for and all they did go for.
I've said since 10/16 that the FDA stretched what the approval request was to:
"If we approve you for 200 to 500 Trig reduction you will say Vascepa reduces CVE's because you think reducing Trigs reduces CVE's and because that has not yet been proven, you will not be approved for the 200 to 500 class..."
The FDA thought too far outside the box instead of taking baby steps and approving the 200 to 500 class with the same label exceptions that Marine has regarding Vascepa not tested or proven to reduce CVE's.
My take: Vascepa will be approved to sell in the 200 to 500 class with the same Marine label exception.
Maybe we will win one over on the FDA in 3 years: "FDA Announces: Vascepa reduces CVE's!" with the FDA saying it is because of Trig reduction when truly it is because it reduced Inflammation!
SHHHHH! Don't tell anyone!
nutsyprofessor Spot on... The thought though is that Vascepa will reduce Inflammation yet right now that is not a study in the works by Amarin.
nutsyprofessor:
Thanks for the Post! I learn from many of them...
I've read your very much appreciated Posts yet am not catching your position on Vascepa...
Short question:
Is it your opinion that Vascepa is a great, unique, and much needed product that will help keep people healthy?
Thanks for all of your input!
Today's Posts: (see Posts below between noon and 3:00 pm):
I find it disturbingly interesting that there are so many various opinions regarding the purpose/goal of Vascepa almost to the point that it may make sense why the FDA is having so much difficulty determining what the real purpose of Vascepa truly is.
All posters are probably "correct" with their positions yet reading all of them while trying to understand what Vascepa really does it is like pushing dough down: You push it down here and it pops up over there.
The Posts create enough confusion to make one think that maybe this is the very same quandary that the FDA is facing.
How is this solved or resolved?
Outside interests like Big Pharma will do whatever they can to not help Amarins' cause and to throw mud in the mix to slow them down.
Questions:
Does Vascepa drop Trig's and that is its sole purpose and worth?
Does Vascepa reduce Inflammation yet (at the same time) is not something Amarin is out to prove?
Will Amarin prove a reduction of CVE's with Reduce-It yet will the FDA determine in 3 years that it was not because Trig's were lowered yet (at the same time) not realize it was because Inflammation dropped?
The last question is one that keep circling in my mind...
Leaves me wondering:
Who will come up with and Patent a product in the meantime that reduces Inflammation which proves to reduce CVE's leaving Vascepa as a Trig Lowering Drug only?
Horrible thought:
If Amarin does not seek to Reduce CVE's via a Reduction in Inflammation, they will always and only be a Trig Reducing Drug.
Am I correct in saying this?
Any thoughts?
zoobuffdoc No apology need to me... Great letter! Just wanted you to be aware in case you get a call or feedback from the recipient questioning that! I think I will remember that day for the rest of my life like recalling where I was for the Shuttle Disaster or anything along that line! I was on vacation sitting on my cousins back patio staring at my cell feeling quite pale! In at 13.00 per share with 17k shares and still holding BECAUSE I BELIEVE IN THE PRODUCT!
zoobuffdoc You note in your letter that Adcom was Mid-September... It was October 16th...
L0tsaluck2000:
2-B yet the only Label restrictions will match Marine:
"Vascepa has not been proven to Reduce CVE's"
...yet I do not think it will take months... I think the Label change will be allowed immediately.
Stock:
1. Quick Rise/Jump to 5.00 then a slow rise mirroring Sales.
2. Next Run: As we get close to Reduce-It results.
3. Next time we see 15.00: Buy-out, Partnership, Positive Short-term Reduce-It results...
JOBSONJOBS: You will get many different answers yet this has been my "short-take" from the beginning:
Amarin in their Anchor Application stated in more or less words that their Target market is people with CVE's (Cardio Vascular Events)...
On October 16th: The FDA (right or wrong) ran with the thought that if Anchor is/was approved that Amarin would "state/imply/sell on the point" that Vascepa reduces CVE's...
The FDA said NO you cannot do this until you prove it can and will.
What Amarin should have done was state Anchor was ONLY an extension of the already approved Marine indication (treating people with "Very High" Trigs of 500 to 1000) requesting the approval to Treat people with "High" Trigs (199 to 499)...
This would have allowed Amarin to sell to 30 million people on label (as opposed to "off-label" like Lovaza does) and not just the 2 million in the "Very High" class.
This would have given Amarin the money they needed to complete the Reduce-It study.
What do I think will happen now:
Amarin will get an Extension of the Label allowing the treating of people in the "High" class with an exception stating that Vascepa "has not been proven to reduce CVE's" just as the approved Marine indication states.
Jesse and Bio: Look at what you posted for Vascepa then look at the extent of the Lovaza literature... Read from Section #4 onward in the link below... Almost all of the same applies to Vascepa except the DHA concerns of Lovaza.
http://us.gsk.com/products/assets/us_lovaza.pdf
Here is what I see: The FDA may not be "picking on Amarin"... They may be re-reviewing their Labeling in full which is not a bad thing IF the FDA is considering a Label change to include some or all of Anchor or what I think will be: The Inclusion of the Lower Trig class...
I am trying to see the upside to the FDA "paying attention" vs. seeing this as a "gonna getcha" move...
I think the FDA is trying to get Vascepa up to par with Lovaza which is a must if or before giving it any additional latitude in its class...
The GSK Lovaza literature found on line in one hit on Google is quite extensive vs what Amarin shows for Vascepa.
GREAT ARTICLE FROM EARLY OCTOBER...
This puts it ALL back into perspective in one article...
Especially the BOLD portion!