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Chabojilo - You hit it on the head!
I called Amarin today around noon and asked Joe Bruno why the "CVE" and "Risk Group of people on Statins" was added to the Anchor app... He said it is normal to add the target group you are treating to the application...
WELL: They did not do that in the Marine Application YET were smart enough to write the following in the (Marine) application:
1. "Vascepa is not proven to reduce Inflammation in the Pancreas."
2. "Vascepa is not proven to reduce Cardio Vascular Events."
BINGO!!!
It was approved!
NOW: Lets go back and modify the Anchor App to say the very same thing in treating the 199 to 499 class!
I've been saying this since the AdCom Board rejection!
Focus on what the FDA is saying while looking back on what they approved!!!
Seems to easy to me...
Learn from the mistakes to change the future!
august1991... Saw the Seeking Alpha overview...
As someone else said: Going to hold onto the shares until all of the smoke clears with no intention of selling in the foreseeable future...
The FDA cannot say that Reducing Trigs does not help people...
There is a market for this product.
I say it is in the 100 to 1000 Trig class and then whatever other discoveries are made.
Trig reduction is NOT the only benefit of Vascepa. It is the Homerun if it produces lower CVE's...
If not, it is certainly not a dead drug!
Shoot for the stars and land on the moon...
Goodnight everyone!
BidMark: You can find a million posts on line noting from the highest to the lowest organization that reducing Trigs is benefical...
The Jellis study is the only valid study of a Fish Oil reducing CVE's while reducing Trigs right now that hold water.
I am sure Jesse can list one or two more that he has confidence in.
I am a believer in the Jellis study...
Their ONLY argument on the US side is thin: Japanese people eat a lot of fish and the successful results are possibly skewed because they have an inherent Fish Oil property in their blood stream...
REALLY???
The FDA is using two products that do not treat CVE's like Purified Fish Oil...
The FDA is saying: Show us yours does...
There is nothing out there that says it doesn't YET there are a millions of posts and a few studies valuable that says it does!
STS66: I spoke to Amarin's Joe Bruno (Amarin's PR person) today and asked that very question...
Getting to 2016 is the Goal now...
Covering the Bills (not including Reduce-It) is not out of the question right now (according to recent reviews of their Cash on Hand and anticipated potential income...)
Finding the money for Reduce-It) is the target.
Amarin has to find other benefits of this Drug looking into additional testing and SPA's while considering a partner!
This is an excellent product with a road block that is not too large to hurdle.
Amarin was only told: Show us your product reduces CVE's...
This is NOT JUST AN AMARIN issue... The FDA is effecting and planning on effecting many many drugs in similar circumstances!
With that said, we cannot look at this as "the FDA hates Amarin."
Everyone needs to get over that thought - it is certainly not the case.
We have to now work with the FDA to find a way to achieve the Reduce-It study (if they can find a way to help) and as well find other uses for the Drug and 30+ Patents that will benefit other issues...
I am still not understanding why the FDA cannot or will not approve Vascepa for treating people with Trigs between 199 and 500 without the CVE language. The FDA already knows it will cleanly reduce Trigs in the category. Doing so will increase sales and cash flow and possibly get us to 2016! Maybe they will if Amarin goes for it. They certainly do not need to ANY additional testing! They've already proved it will in the Anchor testing.
The question I need help on: Do Trigs in the 199 to 499 range have a negative effect on any class of people where it is important to reduce them from this level and if so can you shoot back examples?
I have been reading issues with Trigs between 199 and 499 and Diabetes I believe.
Any help?
I want to learn...
My typed opinion is wrong because the announcement came out as I was typing my opinion...
Only benefit I see: Amarin can start talking to the FDA now and not wait until the 20th of December...
Good or bad - who knows!
Best Post I've seen in a while!
Positive thinking!
I spoke to Joe Bruno of Amarin today... He called me back within 10 minutes of me leaving him a voice-mail.
I asked him a couple questions that have swirled in my head:
1. Who added (similar language) to the Anchor Application Amarin
or the FDA:
"Treating people on Statins with CVE Risks"...
He said it is common to write in the application exactly what
the language of the Testing is geared towards...
I was under the impression that it was an Amarin decision.
2. If rejected on December 20th, why not apply for Trig treatment
only in the 199 to 499 class... I continued saying if we are
approved (Marine) to treat people in the 500 to 999 class, why
not extend the success to the 199 to 499 class? I as well said
the FDA knows Vascepa reduces Trigs in the class so why not
get the OK so we can make money to get us thru the 2016?
He said it is expensive to take on End Point specific testing.
Note: He did not rule this out - he just said what I note
above... I did not understand why additional testing
would be needed if they already proved the drop in
the Anchor testing... (Nor did I ask him - He is a PR
guy - I did not expect him to elaborate too far on my
questions...)
3. I asked him if the FDA knows Trigs between 199 and 499 are
not good and we are a Best in Class to reduce them, why not
get that particular approval in a modification to the Anchor
application to make us money to get us thru 2016?
He sald all options are open with the FDA between now and
December 20th...
He said at the on-set that Amarin is working closely with the FDA now and thru December 20th to find a way to change or modify anything that may see us thru with an approval of Anchor.
I felt very confident that they are all over this like we are on this Board with each other!
He sounded just as surprised as all of us with the FDA's decision.
I also felt (from his words) that the entire Team is/was just as surprised.
His take on this sudden and unexpected change two weeks ago (his words): The FDA approved Niacin and Fibrates only to discover later that they may not and/or do not Reduce CVE's and with egg on their face said: What do we do now with Vascepa?
I told him it appeared if we get a full rejection on the 20th that there are only (3) possible paths:
1. Get a conditional Approval on or after the 20th by working
with the FDA.
2. Partner with the likes of GSK to market the current
approval (Marine)...
3. Get a NO then diminish the Stock value with splits to make
money to get the SPA done by the end of 2016...
I did not ask him for a reply to the above yet told him that there are many many people hoping that the Amarin Team does not lose sight of the fact that we are out here watching and waiting.
In closing:
He was extremely polite, shared in our surprise, and impressed on me that the Amarin team is all over this and will work to do whatever it takes to get a full or modified approval.
He did not comment on any "chances of success" nor did I ask him because it was very obvious to me in talking to him that Amarin is treading on brand new ground and has to blindly see their way thru this.
In my opinion (and this is NOT from anything Joe said or implied in any way - this is solely my opinion):
We are not going to get an OK with the language in the Application as submitted. Our best chance is to get some type of modification that allows us to market Vascepa within the Anchor format meaning eliminate the CVE and Statin language.
Otherwise we have to put Anchor on the back-burner 100% until 2016 or 2017 (or until the FDA gives us an OK to move ahead with it.)
Other options down the road: Additional Endpoint specific testing of Vascepa for other conditions (which as Joe said costs money and must have a specific target population...)
In short: If we do not get an OK on a modified version of Anchor, the NO will happen on December 20th and we have to find a way to make money to get us the 2016...
On another note:
There seems to be a circle of conversation on this board talking about the FDA "breaking the SPA" which they did not do (they just delayed it) or finding that the FDA "broke the law" or "the FDA broke an agreement" or "broke a contract" - ALL the FDA did was allow Amarin to submit an application. Getting an SPA does not guarantee an Approval.
Hopefully Amarin can convince the FDA to "change their minds" or approve a modified version of Anchor!
Vascepa - A revised Anchor Approval on Re-submission down the road?
I've been saying that the FDA needs to see the people with CVE risks/target group language eliminated from the Anchor Application.
The case below is an example of what I am hoping happens...
In our case (maybe):
We get the Letter explaining why we will not get Anchor, we negotiate a change in the Submission language, resubmit, and get a conditional approval like one or two of the AdCom Board Members asked for...
Any thoughts?
JohnKing29
Vivus: Qsymia for Obesity
Like Protalix, Vivus (VVUS) successfully negotiated a SPA agreement for key elements of the pivotal Phase 3 clinical trials of Qsymia for the treatment of obesity and weight-related co-morbidities in 2007. The Phase 3 program would include two pivotal, double blind, placebo-controlled, multi-center studies in distinct populations (EQUIP and CONQUER) comparing Qsymia to placebo during a 56-week treatment period. The program would also include a six-month confirmatory factorial study, known as EQUATE in obese subjects with BMI’s from 30 to 45. This trial would evaluate two dose levels of Qsymia, compared to both placebo and the individual constituents of the combination. The co-primary endpoints for these studies would be to evaluate the differences between treatments in mean percent weight loss from baseline to the end of the treatment period, and the differences between treatments in the percentage of subjects achieving weight loss of 5% or more. All 3 trials were initiated in 2007. The company reported positive results from EQUATE in December 2008, and highly positive results from EQUIP and CONQUER in September 2009. These studies met all primary endpoints by demonstrating statistically significant weight loss with all three doses of Qsymia, as compared to placebo. Patients taking Qsymia also achieved significant improvements in cardiovascular and metabolic risk factors including blood pressure, lipid levels, and type 2 diabetes. The company submitted an NDA in December 2009 which was accepted for a standard review and PDUFA goal of October 28, 2010. The NDA was reviewed by an Endocrinologic and Metabolic Drugs Advisory Committee on July 15, 2010. However the Committee voted 10:6 against approval citing concerns with the adverse events observed with treatment, including depression, anxiety, sleep disorders, other cognitive disorders, metabolic acidosis, increased heart rate and an unclear potential for teratogenicity in both animals and humans. Subsequently a CRL was issued at the PDUFA goal date.
A number of meetings and communications took place between the sponsor and Agency between December 2010 and September 2011. A new route to resubmission was agreed upon seeking initial approval for an indication restricted to obese men and women of non-child bearing potential, until further retrospective studies could be completed to fully evaluate teratogenic risk. Vivus resubmitted the NDA with a proposed contraindication in women of childbearing potential in October 2011, which was accepted as a class 2 resubmission, 6 month review cycle and a PDUFA goal was set for April 17, 2012. The sponsor was notified that the resubmitted NDA would again be reviewed by an Advisory Committee. In January 2012, FDA requested that Vivus remove the Qsymia contraindication for women of childbearing potential contained in the proposed label. Qsymia would remain contraindicated for women who are pregnant. On February 22, 2012, the Endocrinologic and Metabolic Drugs Advisory Committee voted 20 to 2 in favor of approval for the drug contingent on an adequate Risk Evaluation and Mitigation Strategy (REMS) and with post-marketing safety studies. Finalization of the REMS program necessitated a 3-month extension for the PDUFA goal taking it to July 17, 2012. Qsymia was finally approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 or greater (obese), or 27 or greater (overweight) in the presence of at least one weight-related comorbidity, such as hypertension, type 2 diabetes mellitus or high cholesterol (dyslipidemia) on July 17, 2012.
I am well aware that they did not say Amarin cannot Prescribe Vascepa to people in the 199 to 499 class.
What I am saying is get an Approval to treat people with Trigs in the 199 to 499 Class. They are currently approved to do the same with the 500 to 999 class via Marine with out saying they are treating CVE's.
If they get just the 199 to 499 class approval, they can then sell the drug to the 35 million Americans in that class and make money.
In short: We need to make money and it is not going to be Treating CVE's!
We need to sell this drug to people to make money - not convince the FDA to allow us to Treat CVE's.
Jesse - Larry King and Omega XL...
http://www.omegaxl.com/
I am sitting here reading the Boards and Larry King is on TV in an Infomercial Promoting Omega Fish Oil as an Anti-Inflammatory...
They are saying nothing about Trig Reduction...
I think we need to send a copy of this to Joe and his Team!
They are promoting nothing more than it being an Anti Inflammatory.
The infomercial is also saying there is no other drug like it noting they remove most of the DHA!
Amarin should be chasing them down and putting them out of business!
Annac - Thank you for your comments...
JL said it right (in other words than this):
Get Amarin to think outside of their little Cocoon which is: "Amarin reduces Trigs which reduces Heart Attacks..." This board we have here is a group of people with the same interests their board has. We need to give them (Amarin) as much fire power as possible.
The FDA can sit on this issue yet Amarin has to find a way to make more money to get the product tested on the many other uses it has while (at the same time) getting an approval on the 199 to 499 Trig group which is (to me) the easiest path.
My option has not changed:
Dump the words regarding CVE from the application and just go for Treating Trig Reduction in the lower class PERIOD! The CVE language is what pissed them off and the ONLY part they have a problem with and/or could grasp. The AHA and the ACCE both agree that Trig reduction is important. The FDA cannot ignore either - more on this below. Now neither the AMA or ACCE can say trig Reduction reduces CVE's YET why do we (Amarin) have to say that in an Application then lose the ability to treat the whole class (which is where the money is!)
IMHO:
Jesse is not saying Reducing Trigs reduced CVE's... Jesse is saying EPA reduces Inflammation which is most likely the cause of CVE's... What he is fighting for is finding a financial path for Amarin to keep all tests going (including the SPA) to discover ALL of the benefits of this Product! I say the short-term fight is getting Vascepa approved for the 199 to 499 group to make sales (income) to discover all of the other benefits of Vascepa/Pure EPA! How do we do that: Take NO on December 20th and either Appeal (if that is possible) asking for a Language Change eliminating the CVE wording or Re-apply changing the wording eliminating CVE from the new application. (I say we call the new application "SAIL" knowing it will "sail-thru" keeping with the Nautical theme Amarin created!)
How can they say no to approving a drug that reduces Trig's in the 199 to 499 class? The FDA would have to say Trigs in the 199 to 499 class are 100% OK and do not need to be reduced and are perfectly harmless! THEY WILL NOT DO THIS!
Getting off my Soap Box:
I am not going to lie to you: I am not out to reduce CVE's in people - I am out to make money as an Investor! I will say I am a 100% believer in the product so do not misunderstand my comment...
Amarin MUST find a way or ways to increase income for other Tests! The Marine approval of the 499 to 999 Trig class is just not going to do it!
As Jesse said: The product is much much more than than Trig Reduction...
I emailed Amarin's PR generic Email box asking if there is an Email address where I can email (not inundate) Amarin with comments/letters from the various boards...
We will see if they reply.
I will as well call them if I do not get a reply...
The Amarin team in my opinion is the only path to the FDA in getting valid attention. The FDA, Congressman, Petitions etc... will not give a positive response to any of us. The fight is between the FDA and Amarin. Hitting them with everything though is a must!!!
In short I am saying that ALL correspondence should go to BOTH the FDA, Congressman etc and to Joe and to EACH of his Amarin Team individually (at the top) to be sure the letters do not collect in a junk pile anywhere.
If we just send the letters outside of Amarin, I suspect they will be read (sooner or later) then put into a pile of "Thanks for your Thoughts".
If they are sent to ALL parties there will then be another group for the FDA and Amarin to contend with (vs each other) - The Group that pays for ALL of their salaries!!!
We assume Joe and his Team know everything we do and are fighting the same fight YET there are MANY valid points on this board that may or may not be swirling in the Amarin Team heads right now.
It only takes ONE point to throw the issue back on the table for reconsideration.
I am far from technical like many on this board YET do carry common sense.
ALL parties need to be copied on ALL Letters, Petitions... so they ALL know the General Public (who they ALL work for) are watching their every move.
Does anyone have access to the Main Amarin Team Players Email addresses (or even one person like their PR guy?) I would love to copy and paste all of the positive findings and/or reports from this board whether I think "they know that stuff" or not!
Again, it only takes one or a nice group of more than one comment and/or study.
My deja-vu in my head right now: On December 21st we are asking ourselves if Amarin did anything with the FDA to try to convince them to change their position.
Amarin has been too tight lipped about anything that interests us for the last few years!
My take is that they (suddenly) decided to just stop approving drugs until they have a full OK across the board. Amarin was the 1st in line to get kicked in the butt and/or used as an "example"...
Imagine you being in the FDA and finding "another" drug that harms people that you OK'd while having another at your doorstep to OK without the endpoint study done? The timing was suspicious.
Also, the FDA has been tightening approvals over the last year or two.
I think they should have let Vascepa pass then stop or tighten the requirements on all future SPA's...
Not basically quash one mid-stream!
NICE FIND!
If Amarin does not find a way to continue the Reducit study, they are basically saying they have no confidence in a positive outcome WHICH I highly think will not happen!
There are too many positive signs that it will show a benefit or benefits that will let the value climb!
If we do not get a change in December, partnering with someone like GSK is from what I can see our only hope right now to keep our Stock value stable...
Other options like borrowing or dilution exist yet that would be sickening to all!
AMARIN: Reason for FDA Concern?
Wrote this a week or so ago (see "Previous Post" below):
Does anyone think this issue with ARIA that popped up just before the FDA slamming of Amarin played a part in their sudden "concern for safety" and change in how they handle new products?
Previous Post:
ARIA TODAY: Go look at this stock today! Down 40% on very very bad final SPA type testing and reporting that the FDA will have to investigate this product Approved by the FDA (similar approvals just denied to Amarin!)
Link:
http://www.fool.com/investing/general/2013/10/18/are-these-2-massive-biotech-losses-worth-chasing.aspx
100% Guarantee this was on the minds of the FDA when they went into Wednesday's ADCOM...
Now the FDA has to find out why people are dying and experiencing Heart issues.
They approve what was a questionable product with potential issues.
They then panic and reject a proven safe drug breaking their normal protocol creating new rules along the way in a sick and hasty way!
I am sure this was a major issue in their minds when denying the Anchor sNDA.
Two completely different products on each end of the extreme of Safety.
Question that is MAJOR out today: Does the FDA change the rules now for ALL products heading into SPA's or do they stay the course and allow safe and effective one's while cracking down on the questionable ones.
Gonna get very interesting on the Big Pharma front and this will certainly (hopefully) play into the December 20th vote.
Hopefully the FDA see's the light and realizes that they went too far on Vascepa...
If not: Vascepa will be the 1st example for ALL future approvals for Big Pharma and companies like Vascepa! Not gonna bode well for anyone!
Gonna get real interesting!
By the Way: Motley Fool article notes Amarin a good investment!
Excellent Letter...
I suggest you blind copy Amarin's Team and I mean all of them to be sure just one copy get's filed in a Junk Mail pile!
Gives them more support in hearing what the Investor's perception is of this mess!
I am an Investor and as a Technical writer from time to time, impressed with your clarity!
Please make sure the Amarin team gets a copy!
THANK YOU for your work for all of us!
Well said!
We can ask for a new sNDA without that language or ask for a modified approval before the 20th...
Or we can get the rejection on the 20th then submit an appeal.
Not sure what processes are available yet Joe Z did say on the CC that Amarin would be spending a lot of time at the FDA between now and the 20th.
WE LOST THAT ARGUMENT!
Drop to "Trigs and successful Marine endpoints", pick up the pieces, and start making money!
The FDA changed the question for failure!
In effect they did say No already.
They won't go back on that yet may allow a reduced approval deleting the CVE language from the app.
Amarin's team needs to revamp and ask for a lesser approval.
Something Adcom board members suggested yet the FDA could not allow based on the app and that their bosses probably told them to ignore at the Adcom meeting!
I understand that yet the FDA said no.
Every sentence keeps ending with CVEs.
Those letters must go away!
Change it to Trig reduction only in the High Class and let Vascepa go from there.
Look at Amarin's original Anchor label...
Nothing about statis or CVEs...
Just Trig reduction in the High class...
Somewhere it changed and they went for a homerun!
Amarin needs to take a step back, take a breath, and reappky dropping the CVE language.
The FDA grabbed that and ran withbit punishing Amarin.
If the FDA initially added the "statins for people with high risk if CVE's, then they got cold feet and quashed that, go back and reapply for the original Amarin labeling language you noted in your post!
All the FDA is saying is to not ask to trwat people with CVE's.
To save face (maybe illegally or unethically) used the AdCom board to reject it using them as the fall guy.
If we reapply using the original language how can they say no if Marine is already a no brainer approval.
The FDA wants nothing to do with tewating CVE's before Reducit is done.
Ok then... Give us the extended Marine ok to keep us solvent thru Reducit.
We wont market it as a CVE treatment!!!
Request a modification to the app back to the basic request of Lowering Trigs, an extension of Marine.
The gets an approval to expand the label to generate more income immediately.
People on other boards are asking why we as investors were all told that was what Anchor app indication was for yet somewhere it changed to that plus treating people on Stains who have a higher risk in CVE's.
The change is what sank us!
Go back to the original intent and work in other treatments over the next 4 or 5 years.
If eventually Reducit fails we will have major footing with excellent cash flow to take that hit and still survive.
I am a firm believer in Jelis and believe Vascepa will succeed.
Getting the right start and we'll be flying.
Modify the app before Dec 20th, ask for a reduced approval... anything to get back to the original intent of Anchor.
Can anyone tell me when "the extension of Marine" turned inti "treating people with high risk of CVE's?"
Does anyone agree or disagree with this logic of a revised path?
Anyone? Comments?
In short Amarin got what they asked for...
They need to go back and ask for a modification of the Anchor application language and bring it back to the original intent.
They will NOT change their mind on testing people with CVE's before the SPA is done YET there is no reason why they can't be the first and only approved to reduce High Trigs (199 to 499...)
We need to focus on the intent of the original application, the FDA's reply, and then figure out what they will accept.
There is absolutely NO reason why the FDA will not approve Amarin to treat people with High Trig's alone!!!
They made it very clear:
They won't let them treat "people at risk for CVE's"...
The Board answer which is not wrong is "No" to treating people at CVE risk until Amarin proves it reduces CVE's!
In short:
Amarin needs to keep the product use where it knows it works and build from there slowly...
Go back and negotiate the extension of the Marine approval (like Anchor was supposed to be) which is for lowering trigs (and 100% of its other successful endpoints... )
Not for treating people with CVE's.
Suing for breaking SPA is not going to get us anywhere. They do not have to allow Amarin treat people with CVE's.
They never promised it and do not owe it.
Treating for the Lowering of Trigs in the 199 to 499 group - Amarin should be the first and only!
Anchor application said (paraphrasing):
"...for the treatment of people with high trigs on Statins at risk of CVE's".
What it should have said was:
"... for the treatment of reducing high trigs."
Was this intentional by an aggressive application writer or just a typo?
It clearly says Amarin wants to "treat people with CVE's"...
Anchor was only supposed to be an extension of Marine which makes no mention of CVE's.
Why allow an application ask for an "early approval" of the SPA?
Joe said in the Conference Call that I listened to in full that there is going to be alot of communication between the FDA and Amarin between now and the 20th of December...
BIOBILL + DRR - Check out this mess for the FDA:
http://www.fool.com/investing/general/2013/10/18/are-these-2-massive-biotech-losses-worth-chasing.aspx
End of article positive for Amarin...
JohnKing29
ARIA TODAY: Go look at this stock today! Down 40% on very very bad final SPA type testing and reports that the FDA will have to investigate this product Approved by the FDA (similar approvals just denied to Amarin!)
Link:
http://www.fool.com/investing/general/2013/10/18/are-these-2-massive-biotech-losses-worth-chasing.aspx
100% Guarantee this was on the minds of the FDA when they went into Wednesday's ADCOM...
Now the FDA has to find out why people are dying and experiencing Heart issues.
They approve what was a questionable product with potential issues.
They then panic and reject a proven safe drug breaking thier noramal protocol creating new rules along the way in a sick and hasty way!
I am sure this was a major issue in their minds when denying the Anchor sNDA.
Two completely different products on each end of the extreme of Safety.
Question that is MAJOR out today: Does the FDA change the rules now for ALL products heading into SPA's or do they stay the course and allow safe and effective one's while cracking down on the questionable ones.
Gonna get very interesting on the Big Pharma front and this will certainly (hopefully) play into the December 20th vote.
Hopefully the FDA see's the light and realizes that they went too far on Vascepa...
If not: Vascepa will be the 1st example for ALL future approvals for Big Pharma and companies like Vascepa! Not gonna bode well for anyone!
Gonna get real interesting!
By the Way: Motley Fool article notes Amarin a good investment!
Million Dollar Question: Would the FDA outright reject Anchor (as an extension of Marine alone) if lets say (hypothetically) 3 years aho it was 100% proven that Trig Reduction does not reduce CVE's.
If Anchor excludes or excluded ALL language of Statins and the letters CVE and went for Trig Reduction in the 199 to 499 group ALONE why would today or in 10 years from now (wth again the hypothetical that Reducit fails) the FDA outright reject Vascepa as as Trig Lowering medication in all Trig classes?
They wouldn't or shouldn't OR they would have to quash any and all Meds thst reduce Trigs and say Elevated Trigs at ANY level are NOT bad which they can't!
This is what Amarin needs to drive home
Understood yet having a Lovaza that can cover the 199 to 499 and high would be much better than nothing.
I am not questioning the past just saying a revised app may get an ok just as the Marine did.
I am repeating myself too much.
I'll stop. Probably irritating people!
2 x's Lovaza or 2 billion as a whole less debt...
Lets hope for a rewording or modification by the 20th with an ok.
Not holding my breath.
I do not think Joe is smart enough to see the light or he is smarter and knows the Trig reduction alone in the 199 to 499 is worthless.
Basically all we should have gone for (in hindsight) is the extension of Marine less the Cve and Statin language.
Basically end up with Lovaza on steroids.
Institutional Selling today: Anyway to tell who sold and how much?
Drr - I cannot post privately...
Not stated yet implied and picked up on by the FDA:
The sNDA presently is for use with statins in patients at risk of CVD (the following is from AMRN's brief to the panel)
Quote:
--------------------------------------------------------------------------------
Amarin Pharmaceuticals Ireland Limited (Amarin) submitted a supplemental NDA to the FDA on 21 February 2013 seeking approval of Vascepa for treatment of elevated (200 to 499 mg/dL) TG in patients with mixed dyslipidemia. The proposed indication is as follows:
Vascepa (icosapent ethyl) is indicated as an adjunct to diet and exercise and in combination with a statin to reduce triglyceride TG, non-HDL-C, ApoB, LDL-C, TC, and VLDL-C in adult patients with mixed dyslipidemia and CHD or a CHD risk equivalent.
--------------------------------------------------------------------------------
To eliminnate this line:
with mixed dyslipidemia and CHD or a CHD risk equivalent.
This line implies they are trying with this Submission to reduce Heart Attacks which is what the SPA is for...
If they said they were just trying to reduce Trigs like in the Marine Application maybe we would not be talking about why the FDA rejected them yesterday.
I think Vascepa went for a home run and failed.
Modify the application or ask for a change in an approval to the Trig reduction only in the 199 to 499 class.
Let the doctors then prescribe it off-label for those with Statins and CHD's...
Can Amarin withdrawal and/or modify their application that will allow a modified approval?
Meaning is that an accepted practice that the FDA employs?
I listened to the entire Conference Call and Joe sounded completely clueless in such that "getting the FDA to change its mind is slim" as though he is stuck with tje application as is YET one would think by 700 pm last night he might have ideas.
He sounded clueless like its all over...
Well hopefully Amarin can put something modified together that the FDA will consider by the 20th.
...and partner with Big Pharma like Joe said he will do vs continuing to "Go it Alone"...
This will increase income quickly!
GSK is the best choice!
We'll see!
I see no other options!