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Thus the significantly magnified risk of CVD in Diabetics.
It is still difficult to comprehend how strong prescription growth for Generic Lovaza has been over the last month! MDs are still prescribing lipid therapies heavily, just hope the move to Vascepa accelerates soon.
Raf, were you mistaken about those PACER documents or is there no one available who can access them?
When I recently alluded to the possibility that FDA sees Amarin success as a negative event for the agency, I believe the word used to describe my post was "Hogwash". Perhaps my thesis was unclear or maybe just disagreeable. My point was that with a drug as successful as Icosapent Ethyl at treating so many chronic conditions, much of Big Pharma will eventually be impacted as their high margin pipelines become less "critical". That might force some belt tightening that reorients their R&D expenditures. Fewer new drugs up for approval means fewer heads needed at the FDA. That's an "outcome" that I can certainly get my head around!
Thank you HDG, well laid out evaluation of events and expectations and consistent with your prior posting history.
BC, these studies consistently demonstrate significant EPA efficacy on atherosclerotic plaques. The CHERRY results will absolutely seal the deal on Reduce-It if the efficacy is anything near these EPA studies. I know it's been posted already, but when are we thinking CHERRY results might be publicized?
Remember that stock option news was published in Toronto, so probably issued at current price in $Can. Still, there's long term sentiment on display, and there is rational activity ongoing. The Titan is beginning to breathe!
Statement from FDA letter -
"For example, although it may not be Amarin's intent, the use of the qualified health claim could lead physicians to prescribe Vascepa in lieu of promoting healthy dietary and lifestyle changes or prescribing statin therapy, which is proven to reduce the risk of cardiovascular events (my addition - by lowering LDL-C)".
This is the real issue for the FDA, there is just too much vested interest (translation - BP money) in LDL-C lowering drugs and other drugs like them for the FDA to allow Amarin to thrive. The FDA is damaged if Amarin is successful because CHD and T2D will require far fewer exotic drugs which means the FDA loses a BIG paycheck.
(Someone has to say it!) I'm partial to Powerboats running from the Barnegat Bay to Buzzard's Bay. I was thinking of something like "My Wet Dream". (sorry, I couldn't help it...LOL)
I didn't look very hard but.....where is this AHOs letter? Thanks.
Anyone have thoughts on whether this FDA letter will be delivered before market close today?
You are uninformed Ricardo, last week was Memorial Day....a US Holiday.
Nah, freak's been here a long time, his aspirations are no longer that lofty! LOL
cmm3rd, historically you've been deliberate in sharing your thoughts on this board, and this time is no exception. I just wanted to take a moment to compliment you on your May 28 email to Janet Woodcock for the superlative bit of wordsmithing that it was. Thank you for your contribution, you've certainly demonstrated that "less" quite often is of greater value than "more"!
You make a good point....makes one wonder. Why not design the trial for real world issue and plan for success. Everybody else does!
Thank you Kiwi.....I'll tell my doctor now.
BioC, is that annualized?
52,000 Shs, 20,000 D Wts, 17,500 E Wts
BB, you gotta admit that there were times in your posting when you sounded like you'd reached the precipice and gone over the edge. That said, there was never a time when the large majority of believers like me ever doubted your sincerity or your drive to right this wrong. I for one am convinced that your brow beating of FDA primps and disinterested Congressman and Senators was invaluable in getting the decision we just received from Judge Moss. Thank you for staying the course and kicking the appropriate A$$.
You are right Zu, BB was a driving force!
I posted a comment to her Forbe's article and I'll just make a simple statement here. This Bimbo is a lying POS and she knows it.
You've got the right ratio today, hypo. Stay on it and good health!
Excellent call HD, you were on it from the beginning!
This may be tainted with self-interest but I hope to read your posts for another quarter century. Cent'anni!
It might be appropriate to consider the following once again. Cholesterol is not the cause of atherosclerosis but it can be a significant contributor to the effect. How much of a contributor, I can't say. But apparently, neither can the Cardiologists as evidenced by the stat that 50% of the SCDs don't have a "bad cholesterol" issue. Diet/cholesterol plays a minimal role (see new 2015 guidelines) except in extreme cases (familial hyper....Kiwi variety, very serious).
We have learned the real cause of atherosclerosis (unless you're a non-believer) and that is Chronic Inflammation! EPA fixes that....but you need to take enough, very low serum EPA levels won't suffice. You need to raise the EPA/AA ratio, but more importantly, you need to raise the EPA. Enter Vascepa!
There's a concern that statins at high doses interfere with the action of EPA and studies appear to validate this. I'm going with Dr. Sears position on this however, that the level of suppression is minimal. Remember, all the studies for any of the benefits show that it's Dose Dependent! In fact, if the statin effect is akin to the kiloton bomb over Nagasaki, the Vascepa yield will rival one of the 50 Megaton or so Hydrogen Planet Busters riding around in our nuclear sub arsenal! (Now that's really inflammatory!)
I think it's fair to say that predictions from those purported SOURCES have proven unreliable and there's no reason to suspect anything different in this instance.
JL, in your Vascepa dosing regimen, what is the indication and frequency for taking 40 mg Aspirin?
Kiwi, I had no intention of implying your questions are stupid.....in fact, they're generally quite intelligent, also deliberate, even designed. "Designed? Designed for what?" one might ask! Why, to elicit a particular response....an anticipated response that permits you to segue right into your next assertion! Cheerio! IMHO.
Kiwi, in the words of an admirable U.S President....there you go again!!
Somebody still has to pay for the Rx......off-label? Nah-nah-nah!
I'm taking 4 gms of V daily, a B-Complex and 40 mg Aspirin (1/2 a low dose) because there definitely is synergy! Stay Healthy!
CBB, for what it's worth, I posted the following sometime over a year or so ago. Still feel the same way with ongoing positive results.
In recent years due to CHF and possibly AFib, I've experienced two significant episodes of ischemic colitis and have dealt with gastrointestinal symptoms similar to IBS for many years before that. The colitis begins as an inflammation to colon or small intestinal tissue due to diminished blood flow through the Mesenteric Arteries. In fact, it's sometimes called Mesenteric Artery Ischemia. I've also had diverticulosis for many years which has also at times become inflammatory and might explain some of the other related issues I've experienced.
After a year of taking Vascepa at the 4gm dose, I have experienced a major improvement in symptoms and substantial reduction in frequency of onset. I will stop short of calling it miraculous, but I've become a V Evangelist to anyone I learn has gastro problems in any way similar to mine. I've had a number of friends and acquaintances with Crohn's and Celiac disease who've provided surprisingly positive feedback, not cures but relief!!
If you know someone having trouble with Diverticulitis who can get themselves on Vascepa, DO NOT DELAY!! Good Luck.
P.S.: Just saw in your post that the MD of the fellow with diverticulitis is an A-Hole! Have your friend try someone else or at least get on that OmegaVia that Kiwi talks about!
I saved this 2015 EPA list the last time you published it Zu, but I didn't realize at the time that you had done the compilation. Many thanks for the effort, it's an extremely useful piece of work! Not to mention your daily research, please keep it coming!
Absolutely nothing of any import that he hasn't said thirty or more times already. It amazes that he doesn't get tired of hearing himself repeat.....over and over!
HD, I thought you were a bit of a stiff. Turns out you have a better sense of humor than most others on this board!! Touche...et laissez les bons temps rouler! Qu'ils mangent du chateaubriand!
AMRN will not directly correlate to moves in the market. It is essentially event driven.
Or working a second job at the FDA Legal Defense League.....
Sorry Whalatane, I read all your posts.....you're about as neutral on AMRN (not Vascepa) as Rafun is liberal on Immigration Reform.....just sayin' LOL
What's the problem.....Judge Moss is working BOTH days! Not sure what he does in his spare time....SCUBA Diving maybe?
The JPM analyst has historically been several steps behind most of the other reputable analysts. His statement is just a way to get his 2 cents in but notice he really says nothing. No analyzing, no reasoning, no valid argument (shit, kinda reminds me of the FDA) just the conclusion that "we don't believe the company will prevail". I wonder who "we" really is?