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I have a problem of graph with no scale. The researcher did't even try to put in the minimal effort (see figure 1) to make the graph more informative since they have the data already. It does indicates the diminishing return of LDL-C lowering. Table 5 also contradicts with figure 1. WOSCOPS's baseline LDL is much higher, yet its reduction in event is lower. To conclude, even if you trust the results of those historic studies, their interpretation is less than professional.
Thanks Rose. I hope Amarin is smart enough to ensure the same problem won't happen with R-IT.
Random thoughts on a hot summer afternoon:
1) Good diet and exercise are good for health and could lower CVD. Good diet and exercise can also lower trig. Can we then infer that lower trig. is good for health and could lower CVD.
2) Whenever I get back my Lipid panel blood result and the trig. level is over 150, it shows red to indicate abnormal level. Why the hack then FDA said even at a trig. level of 400, it need not be treated?
3) I was very excited to learn that multiple independent genetic studies confirm the correlation of trig. level and CVD while same thing can't be said about HDL level and CVD. Yet numerous past and ongoing CVOTs try to proof the effect of HDL raising therapy on CVD. No US BPs, with all their money and power, had ever initiated any placebo controlled doubled blinded CVOT to test the hypothesis of a TG lowering therapy on CVD. On the other hand, a small biotech, with limited financial resources and hated by the FDA, is the first company to initiate such a CVOT. I sure glad Vascepa lower trig. and other inflammation markers instead of raising HDL, otherwise R-IT would be doomed to fail.
4) Do you know Tim Russert had a LDL level of 68 and very high trig. level when he died of CVD?
http://livinlavidalowcarb.com/blog/tim-russerts-fatal-heart-attack-was-preventable-he-followed-antiquated-advice/2403
5) I am worrying about the independence and integrity of the so called independent data monitoring board (DMB). I guess I am just paranoid but you know nothing comes easy for Amarin. Anybody familiar with the DMB scandal/screw up story of a trial sponsored by Peregrine Pharmaceuticals (PPHM)?
That's it for now. Thanks for reading my rant.
HD, in one of your analysis about R-IT, you wrote:
"It is a composite 4.59% yearly event rate (645/7,023/2) for the 2 years (1/1/16-12/31/17), however with 4.59% the interim will not be on 1/1/16. The minimum event rate is 4.38% [based on dates [4.42% - based on patients years till Feb 2016 – 21,867 / 967]), since lower event rate will be resulted in a 2018 final event. The maximum event rate is 4.66%, since higher event rate will be resulted in a 2015 interim event. BUT: as we know the “exact” date (end of 2017) for the final event, 4.38% looks more realistic."
1) we know from interim to final is less than 2 years, most likely 22 months or 1.83 yr.
2) during the 22 months from interim to final, there will be patient dropout due to event triggering. So 7023 should be more like 6700, right?
3) So composite = 645/6700/1.83 = 5.25%, agree?
4) what you mean by "[based on dates [4.42% - based on patients years till Feb 2016 – 21,867 / 967". Please clarify if possible.
5) Do you see a problem of R-IT not conforming to 18-month enrollment period and 4-yr medium follow up as originally designed?
TIA.
"drop in LDL from 140 to 100 equals a 20% risk reduction of CV events"
Unless you can show me a link of a placebo controlled double blinded CVOT to prove the above statement, you are telling me something that's non-truthful and misleading.
Kiwi, does Improve it CVOT shows a diminishing return on further LDL reduction? So a reduction of LDL from 130 to 100 might only be a couple percentage reduction in MACE. Not a big deal.
Zum, I must have missed the AMR102 Euro patent news. So Amarin must have at least two Euro patents since I remember it PR a Euro patent news right before Vascepa approval in 2012. Do you agree?
I don't think Amarin will sell EU Vascepa right unless it's not confident about R-IT success. It might sell some smaller market rights if they need the cash later this year or early next year.
Thanks to greenday, Vascepa marketing push post 1A win:
http://www.vascepahcp.com/wp-content/uploads/50890_ANCHOR_Brochure.pdf
http://www.vascepahcp.com/
Watson appeal on losing the first filer advantage for its ANDA filing. That's enough motivation for filing an appeal. It has nothing to do with extra NCE exclusivity time. FDA works for Obama. Obama wants generic drugs to flood the market ASAP. You should know the story well.
Genetic studies, AIM-HIGH and THRIVE CVOT all show HDL raising therapies fail. Why BP continues to fund those trials? Why BP not do some trig. lowering CVOT trials? Are R-IT and JELIS the only placebo controlled CVOT trials to test the effect of trig. lowering?
BO ultimately depends on BP's interest to buy and Baker Brothers' willingness to sell. We, shareholders, has no control over the final outcome.
A bird in hand is better than two in the bush, Zip.
HDG, I don't know why I have Ukraine in my mind. I meant RT Business Class from/to Hungary if BO is over $20. I apologize for the confusion.
HDG, if the BO price is over $20, I upgrade my offer to RT Business Class. Otherwise, my original offer stands.
There is an old saying in the stock market, tell the time but not the price or the price but not the time. Never both!
HDG, if your BO prediction is correct, I am going to buy you a plane ticket (Economy Class) from Ukraine to our chosen destination of celebration (Vegas?). You deserve it.
HDG, thanks. I know I can always count on you.
Anybody has the Jelis' High TG/low HDL subgroup analysis link? I can't find mine.
For those who have not read the Jelis Secondary Prevention Analysis, here is the link,
http://epadruginitiative.com/files/JELIS_Incremental_Effects_of_EPA_in_Secondary_Prevention_of_CV_Events_2009.pdf
The market clearly think R-IT will fail and disagrees with the above analysis. I think more effort and energy should be spent on debating the merit of the above analysis & why the market get it so wrong instead of BO dream.
Speaking of BO, we can conclude that there was no active BO talk with MYL, TEVA, AGN, PFE, etc going on, otherwise JT could not have bought 20K shares yesterday. However, all bets are off going forward due to Joe Kennedy's appointment to "Strategic Initiative" and JT's insider buy.
Oppenheimer Weighs in on Amarin Corporation plc (ADR) Following 2Q:15 Results
http://www.smarteranalyst.com/2015/08/10/oppenheimer-weighs-in-on-amarin-corporation-plc-adr-following-2q15-results/
Thanks zip for the reply. For me Jelis subgroup analysis makes me confident about R-IT. The two independent genetic studies seal the deal for me. If the R-IT placebo group event rate is over 5.05%, then R-IT will be successful.
I hope you are joking about KK. She's way too controversial. May I suggest Rick Harrison of Pawn Star fame?
HD, you either sleep too late or wake up too early. Either way, take good care of yourself. Our board needs you.
May I ask what supports your belief of 80% probability of 30% RRR for Vascepa in R-IT?
Amarin will issue an 8-K. NCE will be on OB this Friday. HDG will be wrong for the first time in his life and will not be wrong ever again including his R-IT trial success prediction.
I totally agree with STS. The Aug 24-28 negotiation has nothing to do with ANCHOR indication.
Wow, I love the word "Strategic Initiatives" associated with any of my stock holdings. It implies activities and actions to improve shareholder value. Mr. Joe Kennedy certainly deserves said promotion.
FDA's hatred towards Amarin runs so deep that I am afraid FDA will find a way to screw Amarin even with a +ve R-IT if Amarin don't have truthful and non-misleading speech right.
Amarin can't afford to give up any part of its "truthful and non-misleading speech right" now. Without such right, FDA can easily drag its feet even upon successful R-IT results.
Yes, sir. I won't overthink.
Would FDA compromised with Amarin had Amarin lose the 1st amendment lawsuit? Of course not. Furthermore, compromise with FDA now means Amarin would get less than "truthful and non-misleading" speech right in return. Why give up something you fought so hard for?
Will never happen, different share structure.
I didn't realize Baker Brothers own 11% of AQXP. Can we say Midas touch?
" Amarin wanted to make the statement that “[s]upportive but not conclusive research shows that consumption of EPA and DHA [(docasohexanoic acid)] omega-3 fatty acids may reduce the risk of coronary heart disease,” a claim that EPA- and DHA-containing dietary supplements are allowed to make, under FDA’s rules"
I would prefer Amarin did not include DHA in the above statement. Now seems like Generic L and Epanova could make the same claim.
I think that's the same Jeff Overley who predicted a FDA victory and applauded Attorney London's fine performance.
FDA law blog article on 1st amendment win,
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/08/a-victory-for-amarin-further-erodes-fda-regulation-of-off-label-promotion.html
I don't think FDA will appeal,
1) FDA has a weak case to begin with
2) Judge 71-page ruling is quite appeal proof
3) Government is lazy. It prefers to kick the can down the road rather than face reality. Do you think Janet Woodcock want to spend more time on appeal paperwork and get embarrassed again?
Amarin can now market to ANCHOR and MARINE population of 40MM in US. If Vascepa can get 1% of that market, that's 92,307 of weekly script.