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Hi Kiwi; thanks for your concern and your wife's..... :D)
Age: 63
BP 130/83
Overweight? Yes, 224 lbs, 5 ft. 11 in, Med. Large frame, not obese, but getting there. 38 in. waist
Potassium Serum 4.8 Range 3.5 - 5.2
GFR 58 ideal Range >59
Albumin Serum 4.5 Range 3.6 - 4.8
Remaining Serum levels all within Range, values on request.... :D)
Total Cholesterol 228 Range 100 - 199
TG 107 Range 0 - 149
HDL 51 Range >39
VLDL 21 Range 5 - 40
LDL 156 Range 0 - 99
Vascepa costs me $610 for 90 days supply from Express Scripts. Haven't had V for over 6 months. I've been taking Carlson EPA Gems 1250 MG capsules, I believe it has 1000 mg EPA plus DHA, plus other Omega 3. Costs $30 for 30 day (120) supply. Been taking 2 Caps per day when I remember to. Overall still happy with my TG levels and cholesterol levels. Surprised by my HDL as it has improved without paying for a gym membership. Must be all that hard work (physical labor) I've been doing. Diet? well, that's another story. Doc opened my eyes with the loss of Kidney function. Trying to get better at what I'm eating. I take no other meds except for supplements.
My main concern was the interrelationship between Kidney function and CVD risk. Shows me how interrelated all of our vital organs are to each other. What's bad for one hurts the others etc. Smokers, drinkers, drugs, excess sugar..... all play a role. Ever try and eat something that doesn't contain tons of sugar?
Good find Zoo; that may explain why my Kidney function has declined the past two years. Started taking V in April 2013, at that time my Kidney function Glomular Filtration Ratio (GFR) was @ 64 (Lower end of good range). Since I stopped taking V last year due to price gouging and Express scripts doesn't cover V, my GFR has dropped to 58. Putting me at risk for an event. Plus my TG have gone up (228). If Reduce-it is successful Amarin should rocket. However, they need to run additional tests for Kidney function PCR & ACR and EPAs effects on Kidney function. If they can prove that V improves the GFR ratios this would be spectacular (IMHO).
http://www.ncbi.nlm.nih.gov/pubmed/20586950
Ever see the Movie "Silkwood" starring Cher Bono? The Amarin story has become mainstream. Albeit Amarin has gotten under adverse conditions a bit more respect now that it has made the Giant (FDA) "flinch". Why the shake-up in leadership? Similar scenarios have happened numerous times in the Nuclear Industry. Frontline employees who call attention to safety issues regardless of the real impact become "whistleblowers." In Karen Silkwood's case who was a real person, she blew the whistle to the NRC authorities when it was considered Taboo to call in the government. Unfortunately she was killed over what? It was senseless really. Money, power, corruption? These folks become unpopular and are still "outcasts" so to speak. I liken it to racial or religious prejudice. Even though we have the freedom of speech, equality, right to protest, it is still frowned upon by those who don't have the same perspective. Yes, Amarin has thrown salt in the wound, some celebrate our success, some disdain it. Bottom-line is Amarin has stood up to the Giant and made the Giant back down. Now, a big "if", if Amarin can negotiate a proper settlement with the FDA then all the stress caused by the FDA to us longs will all be all worthwhile. all the way to the bank.
Amarin, now has "Whistleblower" status...... maybe just maybe the FDA has a bit more respect now for little Amarin.
Only a "guess" at the monetary damages caused by the FDA at this point.
I would estimate (IMHO) that Amarin should be currently trading @ $25 - $30 pps. Minus today's share price 2.40 is a delta of $27.60 per share x the number of shares per Yahoo = 182.5M (currently, POST-ADCOM). Pre-ADCOM = 130M? Calculates damages at $3,643,200,000...... plus legal costs.... say of $5,000,000. We'll be fortunate to get the legal fees reimbursed.
Pacira trades @ 67.88.... hmmmm what would Amarin trade at if given the green light @ ADCOM?
http://investorshub.advfn.com/Pacira-Pharmaceuticals-Inc-PCRX-20108/
LMAO...... I finally got it..... :D)
Marzan, tend to agree with you. I think the FDA could give a rat's you know what about losing face or having to give away anything to Amarin. Too much postulating going on here. Either show me the money or stfu. Will be surprised anything worthwhile comes out by October 30th...... Our government isn't accountable to anyone or anything....As an example; Here's a little snip-it from our infamous Environmental Protection Agency(EPA) no pun intended, that happened last month August 5th. This is real, I didn't make this up. Has all the flavor of the Ghost busters scenario where EPA Inspector Peck has ConEd turn off the power grid for the Spirit containment structure @ Ghostbusters HQ;
This happened last month and we're just now hearing about it?
"Animas River spill has lingering effects"
An Environmental Protection Agency (EPA) team working to investigate and address contamination at the Gold King Mine in southern Colorado, unexpectedly triggered a large release of mine waste water into the upper portions of Cement Creek, on August 5.
The released waste water was estimated at three million gallons. The release had a low pH and contained heavy metals and metalloids that are toxic to humans, wildlife and livestock if consumed in sufficient concentrations and quantities.
“The accidental release from the Gold King Mine discharged to Cement Creek, which flows to the Animas River, then the San Juan River, and ultimately the Colorado River,” “All river uses down-stream of the spill including recreational, irrigation, industrial, livestock watering and municipal drinking water were suspended in the Animas and San Juan causing severe hardship in the region.
Good post JL. Pinch me however..... both you and HD agree 100%???? Fantastic. I was thinking the scenario's like this. FDA is so used to being the bully on the playground. Little Amarin comes along..... Ahhhh, fresh meat says the FDA. Let's just see how far we get. FDA picks a fight. Little Amarin gets a beat down. Once, twice, three times even....then little Amarin wakes up and says......I'm not taking this crap anymore..... then essentially gives the FDA not one bloody nose, but a second one. Now hopefully little Amarin gets some respect.....:D)
Works for me...
ZOO: Nope, JT hasn't let us down yet. Unless the FDA wants to sweeten the deal with a Duke Snider & Willie Mays Rookie Baseball card.....then well all bets are off..... then I'm all in..... All I'm saying is it's a little too early to be popping champagne corks.
I think you understand this; the message board gets overly exuberant over the most trivial stuff. I say, "don't worry have a home brew" sit back relax..... don't get too pumped up over stuff that's out of our control.
Lets not get the cart before the horse.... read the verbiage very carefully..... Floyd Abrams uses the phraseology..."explore the possibility of settlement" the last line is the tricky phrase....."the parties will file a joint letter advising the Court of their views as to next steps in the case." Let's not read anything into this letter that isn't there. Doesn't say anything about Amarin & FDA have reached any agreements. All this postulating is rubbish talk right now. And I'm extremely long and adding as I can....... :D)
From Bills post
Dear Judge Engelmayer:
August 28, 2015
I write pursuant to Your Honor’s August 10. 2015 Order directing the parties to confer as to
next steps in the case and to submit a joint letter regarding the same. The parties have agreed to
explore the possibility of settlement of this matter. Accordingly, the parties request that further
proceedings be staved until October 30. 2015. on which date the parties will file a joint letter
advising the Court of their views as to next steps in the case.
Untying the Gordium Knot or is it"NOT"... :D), I was not able to reduce my co-pay and have to meet my deductible ($3000 annually) before I get my Vascepa script at a reduced price. $150 for 90 day script.
Finally after much painstaking deliberation with my Human Resources Dept. they've come up with the gotcha......
I have two words with different meanings pertaining to my Consumer Choice Health Plan (Obamacare) vs. POS (Pay out the spincter) or (Point of Service) the old higher premium plan run by United Healthcare, they are;
1) Preventive - to be defined at a later date.... and
2) Maintenance - as defined by Express Scripts; Medications generally taken on a long-term or maintenance basis for conditions such as high blood pressure or high cholesterol.... blah, blah....this is subject to change blah blah, blah blah....
1) The 2015 "Preventive" Drug List put out by UHC has Vascepa listed.
2) The 2015 Express Scripts "Maintenance" List has Vascepa, according to my HR rep Vascepa is not listed on Express Scripts "Preventive" Drug list.
The begs several questions;
1) Where is Express Scripts Preventive Drug List?
2) What is Express Scripts definition of a Preventive medication?
3) What is the relationship between UHC & Express Scripts? I know Express Scripts is a subsidiary of UHC, but apparently they are a separate enough entity to call their own shots. Essentially screw the consumer!!!!
4) Why isn't Vascepa a Preventive med on the Express Scripts? While it is a Preventive med on the United Health care list? Same Corporation right???? Not exactly......
I have every confidence this all changes when Reduce-It results hit the street.
Bolo; please explain......what insurance coverage? I'm beating my head against the wall with my employer, United Healthcare and Express Scripts to get coverage for Vascepa, when it's already on their 2015 approved drug list for Preventive drugs. Seems the only thing these corporations understand is lawsuits, court decisions and some whoopa$$....
Can't wait until my medicare kicks in next year..... these bozos don't know their left hand from their right.....
James Murphy; I take it by your remarks you are not taking Vascepa. If you would be you wouldn't be making those kinds of statements.
"Failure is not an option;" Not sure if it was Lenny Kravitz or Chris Kraft (Apollo 13). I think I'll choose the latter.....
Zuman: You have to appeal the decision and have your PCP approve your script for Vascepa. My TGs are below 200 now. So, essentially I'm off label. I tried posting the pdf of the Approved 2015 Preventive Drugs but Ihub doesn't let you post pdf files. I don't have a url: yet but when I do get an address I'll surely post it here. This is a travesty, that Huge corporations don't have a clue where their own documentation is.....
My HR department is sending Express Scripts essentially UHC own pamphlet.... go figure. Its all about money.....
Thanks qq: Still can't get a direct answer form anyone. I'll try Googling OPTUM. This sounds like ENRON all over again.... No straight answers......
2015 United Health Care (UHC)Consumer Choice: Vascepa is listed as a Preventive Maintenance Drug. Now here's what they don't tell you unless you ask and push hard. United Health Care & Express Scripts are clueless. Apparently its through another UHC prescription drug provider called OPTUMRXPDL,
Zero deductible from your Health Care Spending Account (HSA). However I will pay a co-pay of $120 for 90 days. Better than the $600 fee Express Scripts wanted in January. What pisses me off is why didn't my healthcare provider inform me in January or February? I guess its my fault for not asking the question. Still on the phone w/ UHC. More to come later...
Maybe Guy Lombardo and Duke Ellington having a "Battle of the Bands" with Jerry Garcia (Grateful dead) being the MC. Now there would be a panic..... where's my tickets?
So, it would appear the media has put a different spin on this Hearing than our illustrious web members? So, what is driving the PPS down?
Thanks Stumbling Bear.... Injunction is forthcoming. I like it....
Thanks onerag for reporting on todays court session. Looks good for Amarin again. Looks like the FDA brought a swizzle stick and spit wad to a gun fight again........
Throw a little make-up on Janet from another planet and wallah..... you have Agnes Moorehead.... starring on "Bewitched" as Darrin's Mother-in-Law..... :D)
http://www.imdb.com/name/nm0001547/?ref_=ttfc_fc_cl_t2
She's what we term Coyote ugly..... you wake up in the morning next to her and you chew your arm off just to get away......
HD: There was a PR issued today @ 8:08 am.
8:08 am Amarin will present new in vitro eicosapentaenoic acid study data; found that EPA reduced cholesterol crystalline domain levels in cholesterol-enriched model membranes by 65% (AMRN) : "The purpose of the study was to examine whether EPA, under atherosclerotic-like conditions, can reduce the formation of cholesterol crystalline domains. Our research team found that EPA reduced cholesterol crystalline domain levels in cholesterol-enriched model membranes by 65%...... That's all I could see to capture.
Wow, iHub board is way too serious for me, this is some of my best humor and nobody even laughed..... I feel like Rodney Dangerfield, "no respect" that's why I don't post very much. Little to do about nothing I guess. There's constant hashing and rehashing about stuff that's virtually out of my (our) control that will only be resolved at a higher level.
So, why not laugh about it and be happy????
"We don't need no stinking FDA"
HD: As for my time zone? I think mine is the "twilight zone" :D)
Actually I'm on Mountain Standard Time (MTS) in Arizona, where we don't care about no "stinking day light savings time" AKA know as the " The Treasure of the Sierra Madre" (Humphrey Bogart) and "We don't need no stinking Badges" I thought it was originated from Blazing Saddles.
HD: I stand corrected. Shows you how much I'm on my computer. Now where did I put my stone tablet????
Must be something else that causing activity in the stock then???? Perhaps 2 for 1 sale @ Macy's??? :D)
Hey Raf; the study/PR put out @ 7:00 am today.... its different than the diabetes In Vitro study from last week.
New In Vitro Eicosapentaenoic Acid Study Data to Be Presented at the National Lipid Association Scientific Sessions in Chicago
Jun 11, 2015 07:00:00 (ET)
New In Vitro Eicosapentaenoic Acid Study Data to Be Presented at the National Lipid Association Scientific Sessions in Chicago
BEDMINSTER, NJ and DUBLIN, IRELAND--(Marketwired - June 11, 2015) - Amarin Corporation plc (NASDAQ: AMRN) announced today the presentation of findings from a new in vitro study at the National Lipid Association Scientific Sessions being held June 11-14 in Chicago. The study of the inhibitory effect of eicosapentaenoic acid (EPA) on the formation of cholesterol crystalline domains in model biological membranes subjected to high cholesterol levels (to simulate atherosclerotic-like conditions) indicated a level of reduction with EPA that was not reproduced with other triglyceride-lowering agents tested. The poster, titled "Eicosapentaenoic Acid (EPA), But Not Other TG-Lowering Agents, Reduces Cholesterol Domain Levels in Atherosclerotic-Like Model Membranes," will be presented at the author Q&A session scheduled for June 13, 2015 from 11:20 a.m.-12:20 p.m. CDT.
"This study was conducted in vitro using model biological membranes under conditions of hypercholesterolemia," commented Preston Mason, Ph.D., of Brigham and Women's Hospital and the study's lead investigator. "The purpose of the study was to examine whether EPA, under atherosclerotic-like conditions, can reduce the formation of cholesterol crystalline domains. Our research team found that EPA reduced cholesterol crystalline domain levels in cholesterol-enriched model membranes by 65% (p<0.05) as compared to vehicle-treated (ethanol) controls."
Additional studies are needed to determine if the effects of EPA shown in this study would have clinically meaningful benefit in the human body.
This poster will be presented by Dr. R. Preston Mason, PhD, of Brigham and Women's Hospital. Dr. Mason is also the President and Founder of Elucida Research.
thanks zip, I knew Amarin beat its head against the wall with the FDA. All I'm saying is they need to prove this in court. IMHO the FDA pooched this whole thing and blew things all out of proportion for a drug that doesn't deserve it. GLTA
Epenephrine: Let's hope the Judge is fair, prudent and smart. The other part that worries me is the FDA's allegation of "why Amarin never came and talked to us?" I sincerely hope Amarin exhausted all efforts in trying to establish a dialogue with the FDA. If Amarin can prove they "documented" and attempted communication with officials at the FDA to no avail up to and including Janet Woodcock.....i.e. emails, letters, phone conversations etc. Then Amarin has a " locked down case" against the FDA. If not then things might get pretty dicey. I had an experienced attorney tell me years ago. That one should at least try to communicate with the other party and show cause for why the court should get involved. Hopefully, Amarin has had good Counsel on this as this is Law101....
GLTA
Nuke
Williams, count me in. I'll be the cabin boy if need be.....argghh. Hang the witch from the nearest yard arm I say.....
I find it pathetic to think that some of the BPs that spend $$$ to undermine Amarin (hard to prove IMHO) are now pushing for the Free Speech litigation. Too Chicken to do it themselves. They had to push little Amarin hard enough to make them to take the fall, if that's the case. Yet reap much of the reward if the verdict is favorable. If I were in their shoes I would say...why not? Come to think of it they probably masterminded the whole thing either in concert or separately. Just don't mess with my Statin drugs will you???
Had a teacher who would say..... ok, bend over and touch your ankles. Then he would haul off and whack me with a Cricket paddle and lift me off the floor. To this day I hold this teacher as one of my role models, along with the highest level of respect. Thank you Mr. McGrady..... :D).
Now, as far as the FDA is concerned, they act like the spoiled child at their own birthday party.... They need a good A$$ whoopin....
Right off the top of my head..... Astra-Zeneca? Looking roughly at the percentages of stock ownership in (MIWG) Medical Information Owners Group. approximates 100% give or take. AZN is not a part of this consortium. Kind of odd to see Glaxo-Smith-Kline being a part of this. I always thought all along they were the major culprit in railroading Amarin. Guess times have changed. Of course saving face through jumping on the band wagon couldn't hurt. especially when you have a jewel like Amarin with all its patents ready to blow the doors off the FDA.
GLTA
Nuke
I sincerely hope those arrogant bass turds don't issue a letter on Monday. So, they also get a "Contempt of court" thrown at them like any American citizen would. "We the People" find the FDA in contempt of court..... has a nice ring to it.....
Well said JL; Too bad Judge Moss isn't presiding over the 1st Amendment case against FDA. This will be a precedent setting case for sure. It will show the ineptitude of the FDA.
Although IMHO the table was purposely set by the FDA to undermine Amarin anyway they could. Justice wins in the end.
Last Sunday morning infomercials; Well, I took the bait. Last Sunday AM as a community service most radio stations have talk shows touting anything from weight loss to animal cruelty to wonder drugs. I bought into the wonder drug one. Purity Inc. has come out with a standardized Fish oil capsule (EPA/DHA etc.) with a slight hitch. They added CoQ10 200mg? to their capsules. The first 1000 callers got the special offer of a 30 day supply free if you paid a $4.95 Shipping & handling fee. Along with my order I will receive a bottle of Vitamin B complex. The kicker is they signed me up for receiving this new capsule for $39.95 plus S&H for this new formulation. Once I get the product I'll inform the board. Purity touted that their product reduced LDL-C, I find that hard to believe since DHA is noted for raising LDL-C. Since Vascepa has no DHA or an unmeasurable amount and LDL-C is reduced, how can companies who produce your standard Omega 3 (Fish oil derived) which contain DHA claim they lower LDL-C? It will be interesting to try this new product to see if I get fish burps???? I’ve never tried CoQ10, it’s supposed to have some benefits as well.
Regards,
Nuke “The human Guinea pig”
Main street; I hate to be a prick, but you are in control here not your doc. I think you're educated enough on the efficacy of V to explain to your doc why you should be on V. Refuse the Tricor script. As a matter of fact rip up the script in front of him so he gets the message. Say that you refuse to take a script that will not help you. That you want Vascepa bottom line, final answer. If the doc refuses get a new one. It's a waste of time and money to accept anything else. You owe it to yourself, it's your life we're talking here. The doc is only a consultant. People understand when you stand up and express yourself. Good luck
Nuke
Kiwi; I have no doubt Vascepa will do well enough on its own when the time comes. Let's face it, out of pocket money vs. insurance subsidies is a no brainer for me. I might give Omega Via a look.
when Vascepa becomes the "standard of care" then I won't have to worry about pinching pennies. Until then "I gotta do what I gotta do" find a cheaper alternative for "getting my EPA." Sounds like a Rock and Roll Tune....
Wow, good ol San Francisco, what did you do about lead dust? or did you always use pressure washers?
Vascepa was being delivered under Express Scripts (United Health Care). I never tried to get it through a pharmacy, that's pretty much done now as Express Scripts wants $584 for a 90 day script now. WTF I said? Time to look elsewhere. My doc wrote me a 30 day script which I can take to WalMart to fill, plus with the $70 rebate, a 30 script is $150 give or take. Hench, looks like I try other avenues.
Sardine & anchovy oil EPA, I'll smell like a pizza..... or a stromboli.... :D)
I'm being careful with the paint removal; Coveralls, respirator, goggles. Thanks for the washing the hands tip. One can't be too careful. Wouldn't want to grow a third eye from sniffing lead paint dust.
Kiwi; was getting V through USPS, (90 day). It would sit on my mailbox until I got home. Triple digits. Was on this plan for almost 2 years. I didn't notice any degradation. BTW, sandblaster didn't touch the paint. When it did remove any paint it dug into the wood too much so I stopped. I ran one bag of sand through the machine and shut it down. Power washer would not have done the job I'm afraid. Went back to my grinder and flapper disk.
Hi sts; 2006 Toyota Tundra, 4.7 liter. I really can't tell. Switched over in June 2014. I'll look in the owners manual. Yep, Arizona drivers are just as nuts. Will I switch to Carlson Elite EPA? Don't' know until I take'em. Even @ $78, it'll still be cheaper than my insurance. I do have an HSA credit card buried someplace in my junk mail. I could use that for V but why? My deductible for meds is $2700. Kind of floored me when I found out. Should have seen this coming.