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Does anybody know if the R-IT outcome study endpoint is MACE (like in ACCORD-LIPID)or expanded MACE (like in JELIS and AIM-HIGH)? TIA.
Ajax, thanks for your reply.
I also find the following question/answer interesting from the internet:
Q. Does typing a word in all capital letters mean your yelling?
Ans. If you're PURPOSELY typing in all caps, it can be considered an unnecessary form of emphasis. It's rather easy to type in lower case, and easier for people to understand. So technically, yes, typing in all caps can be considered "yelling" through the internet since it's placing an undue emphasis on every word.
Raf, you are right, I am taking 4g/v despite my TG is about 100. But for friends, the extra copay might be a financial burden that I don't feel comfortable to impose on others.
Ajax, at what LDL level will you be comfortable of having yourself or your family/loved ones taking PCSK9 injections? Anybody with LDL level of over 150 or other levels? I am comfortable of having myself, friends and family of taking 4g/day Vascepa if the TG level is over 150.
HD, art you saying if the composite event rate of R-IT is 4.5%, the interim readout can't occur in 2016 and the 1612 event can't occur before the end of 2017?
Ajax, "The PCSK9's are IMO the best drug to come along in
20 years" is valid if you believe that the lower the LDL level, the less CVD and more healthy a patient will be. Where is the CVOT trial results or proof that give you such confidence. PCSK9 most likely will be a Niacin redux.
PCSK9 is for LDL lowering while Vascepa is for TG lowering.
Watson is a prime suspect behind Fusion CP.
"A drug is not safe if it's not efficacious" can only be valid if the FDA and attorney London, without a hint of doubt, that lower TG for patient with levels between 200-499 will not reduce CVD. Otherwise, the FDA needs to apply risk/benefit analysis. That's why the FDA decision makers get paid the big bucks. If risk is close to zero and the benefit is 50/50, what a unbiased FDA regulator should decide for the well being of patient care?
Freak, I hope you have sold your shares and move on for greener pasture.
I thought Matinas Bio's MAT9001 has a DPA/DHA/EPA IND. Is AZN coping Matinas Bio?
According to the FDA, a drug is not safe if it's not efficacious. Moreover, FDA stated that Vascepa is efficacious for TG>500 but not efficacious for TG<500 (based on the 3 flawed and unrelated studies). If the Judge believes in these two moronic statements, then we might face some interesting time ahead.
JL, always welcome your insight. Do you think FDA's ridiculous definition of "drug safety" hurts their argument of advocating patient safety in the 1st amendment case?
FDA Communication Regulations Hurt Competition
http://www.policymed.com/2015/07/fda-communication-regulations-hurt-competition-.html
Why the change of heart kenyboy?
I doubt it. Otherwise, AMRN stock should be at least $100 by now.
JL, the FDA standard playbook is to appeal right before 60-day expiry and then drop the appeal shortly after. Hope this time is different and the FDA stops looking like a fool for once.
More coverage on the 1st amendment case,
http://www.mmm-online.com/agency/21st-century-cures-amarin-court-case-advance/article/425992/
Thanks to @greenday on twitter.
Chas, note that the Jupiter trial enrolled patients with normal LDL-C level. Can you still conclude that lower LDL-C corresponds to lower CVD rate?
Sam, totally agree. We won't be down for long. Just remember we are the owner of a company which markets a FDA-approved cardiovascular drug with no generic competition until July 2020 at the earliest.
ANAC up 60% pre-market due to successful trial data. Guess who is ANAC biggest holder is? Our friend and backer --- the BB.
http://finance.yahoo.com/q/mh?s=ANAC+Major+Holders
I think we are with good company folks.
HD, do you remember if the expected placebo arm event rate in R-IT to be 5.9%/yr? When Amarin said the trial has been tracking so far to date, does it mean it's tracking to the 5.2%/yr composite event rate? TIA.
Everybody please get along so that we can devote our energy to fight a common enemy and not each other. I happen to love STS' posting style and dislike Raf's style but learn to tolerate. If you can't tolerate anybody's post, just ignore that individual.
Thanks as always Sam for the script info.
Omthera enrolled its first patient in the TG 200-499 trial (ESPRIT) in August 2011, after the FDA was aware of ACCORD and AIM-HIGH results. FDA should not have entered into the ESPRIT SPA if ACCORD and AIM-HIGH are substantial scientific evidence to rescind ANCHOR SPA.
If the following statement from the FDA is true,
"Therapy in the high TG groups alone for ACCORD-Lipid and AIM-HIGH did not demonstrate benefit.
DMEP compared those subjects with TG =300 mg/dL to those with TG < 300 mg/dL, …Event rates are similar among subjects with baseline TG=300 mg/dL and TG<300 mg/dL. … "
I'll have to take a few percentage point off of the 53% Jelis rate from R-IT event reduction rate. Anybody disagree?
In Single Gene, a Path to Fight Heart Attacks.
http://www.nytimes.com/2014/06/19/health/scientists-identify-mutations-that-protect-against-heart-attacks.html?_r=3
Such an informative article need to be read again.
Too bad the FDA only look at their own flawed studies. The fact they approved TG studies of patients with normal TG proves that the FDA is total idiot.
The OIG article implied that the actual Vascepa demand is greater than what company booked as actual sales due to fraud. I guess some greedy doctors/pharmacists use fish oil DS and bill government as actual Vascepa.
The only reason Vascepa was approved for MARINE indication is due to the fact that Lovaza was already approved for TG>500. FDA had no choice but to approve Vascepa because it has less side effects than Lovaza. Even the FDA can't get away with not approving Vascepa for MARINE indication.
STS, FDA will insist that CHERRY study applies only to Japanese arterial lining.
I highly doubt JZ said "we don't know why this works". Even if he said the exact same words, it doesn't excuse the FDA to carry out its basic function, i.e., apply the concept of risk/benefit analysis on Vascepa for ANCHOR approval. If FDA can't do that, then it's pretty much useless.
Power corrupts; absolute power corrupts absolutely. FIFA was caught and the FDA is next.
No seller today and unable to get any shares, opposite to trading action last week.
Emblem Health Tier 3 coverage, $70/month without coupon. My PCP wrote an off-label script for me and I pay $9/month with the coupon.
Coronary calcium scan might be too effective a diagnosis tool that could upset the existing applecart, i.e., too many other ineffective & inconclusive yet very lucrative tools available. Those at power who derives lots of profits from existing treatment options would do anything to impede the success of coronary calcium scan. Now substitute the phrase "Coronary calcium scan" with the word "Vascepa" to my statement above, you'll get the picture. Hope you all get a chance to watch the informative documentary "Widowmaker", free from Amazon Prime. Happy Father's Day to all.
Thanks Kiwi for your article. Have you tried Coronary Scan? I watched a documentary on Amazon Prime (free) named "Widowmaker" yesterday. I think you and every Amarin stock holder should watch it. From the documentary, I learn the possible reason why Amarin get screwed by the FDA so royally.
http://www.latimes.com/entertainment/movies/la-et-mn-widowmaker-movie-review-20150227-story.html
Is triglyceride therapy worth the effort?
http://www.ccjm.org/index.php?id=107953&tx_ttnews[tt_news]=380985&cHash=3b58329df42531043a6b7710e1040630
So far only getting 120 shares of AMRN at $2.36. No seller and not too many buyers either.
Mine is 2,1,6,7,4,5,3 (last because it's in the bag). Otherwise, it's 2,1,3,6,7,4,5.
It is not MIA, just no open interest. There are active bid/ask at various strike levels but pretty wide spreads.