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Many of the insurance moves are done in groups, so keep checking. I would expect another in the top 5 would follow suit.
http://health.usnews.com/health-plans/national-insurance-companies
JL
Your reading too much of my crap! We might have to go on a little trip to Washington this fall for a presentation.
WILL
Akanz
Lovaza $1 Billion in US sales. 75% off label. Anchor will put payer restrictions on that 75% off label to the point of change overs. GSK has seen this, hence they dropped two encapsulators as of a day ago. Anchor 40 million pts, 10% market share is $8Billion. REDUCEIT $10 B plus... World market $30 B. Resolvins... Priceless....
$800 million market share is based on lowest 2014 sales...
Management doesn't pump the stock because they know the science...with all due respect you should too.
Williams
Akanz
In two years everyone, including the clinicians, will know the value of Vascepa. Right now, the focus is 30,000 high prescribers and of course smart share holders like yourself. EPA as a molecule in your blood, is "essential" to good health. Every diabetic should be taking "V" for regulating adiponectin levels.
I doubt any of the clinicians could remotely site the mechanism of action for EPA.
http://www.ncbi.nlm.nih.gov/pubmed/15655035
EPA and adiponectin:
http://www.ncbi.nlm.nih.gov/pubmed/17217160
The science is VERY strong, Amarin fruit is not ripe yet. High levels of plasma EPA will be the foundation to treating numerous chronic inflammatory diseases, this market dwarf's Anchor.
Williams
adiponectin
http://en.m.wikipedia.org/wiki/Adiponectin
DM 2 & atherosclerosis ;)$;)
I guess not...news before the EOD on offer?
Is Amarin going to trade today?
Guessing in the next two weeks, Amarin rejects a low ball offer.
Williams
No BID, No ASK, No crapy article for 5 days...
I like the silent treatment. It's time for the FDA to do their job.
Williams
The risks seems to be NOT taking Vascepa.
Manufacturer
"Manufactured for GlaxoSmithKline by: Catalent Pharma Solutions"
Pronova's not the limiting rate for the production of Lovaza capsules, Catalent is.
GSK reduced it's capacity to supply Lovaza to the market...period.
Lovaza's new label DROPS two suppliers! Now they have one.
http://us.gsk.com/products/assets/us_lovaza.pdf
Old:
"Manufactured for GlaxoSmithKline by: Catalent Pharma Solutions
St. Petersburg, FL 33716-1016
Accucaps Industries Limited Windsor, Ontario, Canada N9B 3R5
Banner Pharmaceuticals Inc. High Point, NC 27265
Distributed by:
GlaxoSmithKline
Research Triangle Park, NC 27709
LOVAZA is a registered trademark of the GlaxoSmithKline group of companies. ©2012, GlaxoSmithKline. All rights reserved"
New:
"Manufactured for GlaxoSmithKline by: Catalent Pharma Solutions
St. Petersburg, FL 33716
Distributed by:
GlaxoSmithKline
Research Triangle Park, NC 27709
LOVAZA is a registered trademark of the GlaxoSmithKline group of companies. ©2013, GlaxoSmithKline. All rights reserved.
LVZ:10PI"
Guessing they suspect demand to drop.
Williams
Williams I'm sick of your GSK has infiltrated the FDA and influenced decisions theory's!
Is China going to clean house before the US?
http://www.nytimes.com/2013/07/02/business/global/glaxosmithkline-under-investigation-by-chinese-authorities.html?partner=yahoofinance&_r=0
LOL:)
The next two weeks for Amarin:
Lovaza's Label has changed, this foreshadows the FDA's thought process.
"LOVAZA is a combination of ethyl esters
of omega 3 fatty acids, principally
EPA and DHA, indicated as an adjunct to
diet to reduce triglyceride (TG) levels
in adult patients with severe (500 mg/dL) hypertriglyceridemia."
I speculate we see the EPA & DHA dropped completely from the label and the mix HIGHLIGHTED. The RLD definition includes the other five Ethyl Esters, the last thing the FDA wants is additional Omega 3's added to the label of unknown pharmaceutical activity, this was their mistake years ago. We're also likely to see a "wild (EPAee)" change as also referenced in the RLD.
From the new API Reference guidance posted in 2012 for Lovaza:
"Omega-3-Acid Ethyl Esters is a natural source drug obtained from
the body oil of several fish sources. The Omega-3-Acid Ethyl Esters USP monograph defines the active pharmaceutical
ingredient (API) as composed of seven individual omega-3-acid ethyl ester components. The Omega-3-Acid Ethyl Esters
Capsules USP monograph 3 establishes ranges for the two most
abundant components (EPAee and DHAee) of the active pharmaceutical ingredient (API) and ranges for the sum of the two components. The reference product contains lesser quantities of the other five omega-3 acid ethyl esters, although quantitative ranges are not specified in the USP monographs. The Agency has determined the quantitative ranges of the other five omega-3-acid
ethyl ester components based on assay of multiple batches of the RLD using the USP monograph analytical method."
===============
Why you should care? Routine maintenance before the FDA !!!FINALLY!!! clears the air around Vascepa's exclusivity. This label has to be posted by July 10th...next OB...12th. Waiting, impatiently...
I'm seeing many GSK connections behind this BS, some connecting the GSK Director of Marketing to the FDA. Amarin investors should keep this in mind when an offer is made.
Williams
If you have Anaphylaxis with fish you should NOT take OMEGA 3 fish oil derived drugs period. There's no guarantee one protein molecule didn't get through processing. One molecule is all it takes to have a full blown your dead reaction.
Aspirin irreversibly inhibits COX-1 and MODIFIES the enzymatic activity of COX-2. IMO this story is unclear and is being studied at this time. ASA and EPA may have a synergistic positive effects on many diseases.
Here's a link to a few hundred articles the NIH has funded $BILLIONs$ over the past 5 years to numerous researchers:
http://search.nih.gov/search?utf8=%E2%9C%93&sc=0&query=resolvins&m=&affiliate=nih&commit=Search
Vascepa is the gateway to this medicine.
Williams/Biobill/Will
I know for a fact that many of these highly educated people have no clue what Vascepa can bring to the table. I've had follow conversations with an Asthma PhD MD researcher/clinician r/t resolvins. He got back to me after he reviewed 2 Brigham and Women's Hospital patents I sent him. Vascepa for exercise induced asthma is amazing, IMO & experience.
Akanz,
Your taking Vascepa now?
Will
Breast and Pancreactic cancer mechanism
http://www.ncbi.nlm.nih.gov/m/pubmed/22903547/
Keep in mind your body can product DHA with EPA, but not DHA to EPA.
Also, this is NEW science.
The only reason not to take Vascepa for ANYONE is a fish allergy. Supplementing the entire US population with Vascepa may indeed greatly improve the health of the nation.
http://www.ncbi.nlm.nih.gov/pubmed/21367944
The science is strong, the FDA is weak.
Williams
Thanks for posting Zum! It was a must read, Amarin needs to take that whole crew to the Anchor Ad Com.
JL, me get carried away? Now that's so unlike me;).
Resolvins are going to be huge! You are of course correct and they are unlikely to be injested. Resolvins will be the metabolite of a "Prodrug" combination of EPA or DHA and target organ specific "catalyst". This is why I believe Vascepa has a very important role to play. Blood EPA levels, vessel specific catalyst puts the Resolvins on target....Vessels. (CAD, PVD, Temporal arteritis)
You should do a temporal arthritis study with Vascepa & ASA vs. Vascepa & IV Tylenol vs. convential treatment.
Will
EPA & CRP new NIH article
http://www.ncbi.nlm.nih.gov/pubmed/23801460
Safety change should show up on:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm338038.htm
Sorry but you are wrong:
"Supplement Type
Companies are allowed to make changes to drugs or their labels after they have been approved. To change a label, market a new dosage or strength of a drug, or change the way it manufactures a drug, a company must submit a supplemental new drug application (sNDA). The supplement type refers to the kind of change that was approved by FDA. This includes changes in manufacturing, patient population, and formulation."--FDA
Easy as pie.
The probablity of me being correct is extremely low;)
However if you change your product formulation to all EPA you'll need a new insert.
Not over, This is the the sNDA dated 6-26-2013 posted today at the FDA.
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021654Orig1s037ltr.pdf
This is not a small change in my opinion, Lovaza's comercial website has been down since the fall of 2012.
http://www.lovaza.com/
GSK is up to their eye balls in Omega-3 Resolvin Inflamation studies with Brigham and Women's Hospital.
http://clinicaltrials.gov/ct2/show/NCT01301794?term=lovaza&rank=15
Brigham and Women's Hospital holds ALL key Resolvin patents and now I speculate GSK holds two key Omega-3 drugs Lovaza and Vascepa.
GSK and Amarin I believe FIRMLY are "partners".
http://en.wikipedia.org/wiki/Resolvins
http://en.wikipedia.org/wiki/COX-2_inhibitor
GSK and Brigham and Women's Hospital are studing Resolvins FACT.
Resolvins are likey to be cutting edge treament for cancers, CVD, Asthma, DM, Crohn's dz....all inflamation!!! BP could build a $100 Billion per year drug pipline fast on Resolvins.
Resolivins are new science and not discussed at all until last week. I e-mailed Amarin the 25 NIH studies. Maybe they had a seeing Jesus discussion with GSK.
Not over, This is the the sNDA dated 6-26-2013 posted today at the FDA.
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021654Orig1s037ltr.pdf
This is not a small change in my opinion, Lovaza's comercial website has been down since the fall of 2012.
http://www.lovaza.com/
GSK is up to their eye balls in Omega-3 Resolvin Inflamation studies with Brigham and Women's Hospital.
http://clinicaltrials.gov/ct2/show/NCT01301794?term=lovaza&rank=15
Brigham and Women's Hospital holds ALL key Resolvin patents and now I speculate GSK holds two key Omega-3 drugs Lovaza and Vascepa.
GSK and Amarin I believe FIRMLY are "partners".
Using ASA to increase RvE's (resolvins) with the coadministering of Vascepa.
Expanded Lovaza label posted yesterday, through sNDA. References 505b application.
Can't find any related GSK IP.
But 8470345 posted today is relavent.
Lovaza label expansion is a fact.
BASF doesn't have 129 clinical trials related to Lovaza, CVD, TIA's, Resolivins MA, and inflamation.
GSK does. Funds likely have two weeks to go long;)
Lovaza's label expansion contains no new IP. Wild speculation of some type of GSK/Amarin relationship in the next two weeks.
GSK has combined forces with BY women's hospital on Resolvin research.
RESOLVINs have been recently exposed by the investment community.
FDA/Lovaza/GSK/ Crowell alleged exclusivity delay
Time for GSK to get the deal done before the price tag doubles
Bio
Lovaza patent search pulls up Amarin Patents:
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=0&f=S&l=50&TERM1=lovaza&FIELD1=&co1=AND&TERM2=&FIELD2=&d=PTXT
Vascepa pulls up Zero patents
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=0&f=S&l=50&TERM1=vascepa&FIELD1=&co1=AND&TERM2=&FIELD2=&d=PTXT
GSK has no new IP for Lovaza:
http://assignments.uspto.gov/assignments/q?db=pat&qt=asne&reel=&frame=&pat=&pub=&asnr=&asnri=&asne=glaxco&asnei=&asns=
This is a label change and expansion. Whatever Lovaza does, Vascepa does better.
I suggest you look at the clinical trials on going.
http://www.clinicaltrials.gov/ct2/results?term=lovaza&pg=7
Specifically #15...Huge B&Y Womens hospital owns the Resolivins patents with the NIH.
Label changes have to be posted two weeks FDA posted letter.
Check out the RED " not available " and neither was the sNDA.
FDA website has high traffic now:)
On February 1, 2013 GlaxoSmithKline LLC submitted a sNDA under 505(b) for Lovaza.
They also submitted an amendment dated April 1, 2013.
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist
It looks like Amarin and GSK intend to get married and have a Baby Lovaza 2, just EPA with possibly a NCE status.
Cool!
Bio
The FDA has a non retailation policy, what you don't trust them? And we all have free will, if they would like to wait...that's fine. But as a citizen and a tax payer I demand ethical treatment. Man-up!
Bio
Those that would like to add I suggest you do it now. I have FDA update web site information that looks to be leaning towards a decision being made. You have an hour then I post.
BioBill
Those that would like to add I suggest you do it now. I have FDA update web site information that looks to be leaning towards a decision being made. You have an hour then I post.
BioBill