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5th line of the 1st paragraph should be "lessen" instead of "lesson". Thanks for your efforts.
Informative interview of Dr. Jenkins:
Great post from cyliu of yahoo msg board :
6/4/14 FDA: " ... complex issues requiring extensive review and analysis by Agency officials."
7/30/14 FDA: "... aware of the significant Congressional and stakeholder interest in the Agency's decision on this matter. FDA is making every effort to resolve the matter as expeditiously as possible, while also ensuring that the Agency's decision reflects a full consideration of the issues brought to our attention in light of all the available scientific evidence."
8/7/14 AMRN PR: "... The FDA's Office of New Drugs recently notified Amarin that it requires additional time to respond to the company's appeal of the rescission of the ANCHOR clinical trial special protocol assessment agreement. Amarin now expects to receive a substantive response to its appeal by mid-September."
Seemingly, the two sides are communicating intensively over certain substantial issues -- restating the SPA or ratifying a substantively changed label (I lean to the later one).
Another positive is that we get confirmation on Jenkins is aware of the APOC3 genetic studies.
Lad, you are wrong again.
The 1-month delay is a great sign.
FDA delayed the decision by 1 month last December then come the infamous MLK weekend compromise discussion between Amarin and the FDA per Ajax's reliable source. Only this time both parties will have calmer heads and makes the best of the situation.
The great JZ is the inventor.
Ajax, thanks for the reply. John Thero got to be the dumbest CEO ever if he indeed failed to compromise on ANCHOR label with the FDA on that fateful MLK weekend. He and Ketchum and other executives got to pocket $150K bonus each if they could market Vascepa for 200-499 TG range population.
Anyhow, thanks for everything that you have done. GLTY.
Ajax, always value your insights.
Did the AHA guidelines came out in November 2013, after the ADCOM?
If the FDA was willing to compromise on the ANCHOR label back in January of 2014, it should have no problem of compromising now with Amarin when the pressure (congress, CP & new science)on the FDA is so much greater? Why can't FDA compromise now? TIA.
Ajax, always value your insights.
Did the AHA guidelines came out in November 2013, after the ADCOM?
If the FDA was willing to compromise on the ANCHOR label back in January of 2014, it should have no problem of compromising now with Amarin when the pressure (congress, CP & new science)on the FDA is so much greater. TIA.
That's how Facebook pushes krill oil supplement :
http://mobile.nytimes.com/2014/08/03/technology/how-facebook-sold-you-krill-oil.html?_r=1&referrer=
Thero might be looking at the pink line while you are looking at the blue line. If Vascepa were indeed super efficacious, R-I might not reach interim until 2016.
Biobill, is this the same rumor that you want to "mature" a bit before disclosing it? TIA.
I am looking at that slide too. It looks great as the blue line goes above the pink line initially then dip below it as we approach end of 2013. It might mean Vascepa started working already. If Vascepa works too well, it might take longer to reach 967 events.
Are you based that off of page CO-73 of Amarin' briefing doc.?
967 events.
Bill, check the following link about Grant Virgin, GLTY and your friend's family. I'll pray for everybody especially the kid :
http://www.cnn.com/2014/01/18/health/fish-oil-recovery/
JL, seems like the greatest risk to R-I trial is if the actual event rate were much less than 5.2%. Hence, it will take a long time to hit 967 events especially if Vascepa is super efficacious. Just wondering anybody can point to any research that justify the 5.2% event rate. TIA.
AK, do you know the size of hetero familia hypercholestremia in US.
Out of all people, your group need the best of Omega-3 therapy, i.e., Vascepa. TIA.
Bio, congrats to you and your family. I don't know Vascepa makes one more fertile until now. I bet your baby will have higher IQ due to the extra EPA!
GSK's whistleblower speaks out about bribery of doctors, off-label marketing of drugs :
http://tv.naturalnews.com/v.asp?v=1fe6404520aa77a877753aa936722510
STS, congrats! Are those bloodwork results before or after your tooth infection problem?
Rd, thanks so much for the info.
Kiwi, I was trying to find the effect of Lovaza on APOC3. "Lovaza ( GSK ) lowers TG's but does not lower APOC3". Is that info. from the L label? TIA.
From the American Heart Association (AHA), regarding Triglycerides :
Triglyceride is the most common type of fat in the body. Normal triglyceride levels vary by age and sex. A high triglyceride level combined with low HDL cholesterol or high LDL cholesterol is associated with atherosclerosis, the buildup of fatty deposits in artery walls that increases the risk for heart attack and stroke.
Mary Parks and Eric Coleman essentially said, by not approving ANCHOR, it's OK to buildup fatty deposits in artery walls & increases the risk for heart attack and stroke.
Also according to the AHA, regarding LDL :
A low LDL cholesterol level is considered good for your heart health. However, your LDL number should no longer be the main factor in guiding treatment to prevent heart attack and stroke, according to the latest guidelines from the American Heart Association. For patients taking statins, the guidelines say they no longer need to get LDL cholesterol levels down to a specific target number. A diet high in saturated and trans fats raises LDL cholesterol.
For a number (i.e. LDL) that "should no longer be the main factor in guiding treatment to prevent heart attack", the risk/benefit of taking Statins is just not worth it, IMHO.
Pls. see link for detail :
http://www.heart.org/HEARTORG/Conditions/Cholesterol/AboutCholesterol/What-Your-Cholesterol-Levels-Mean_UCM_305562_Article.jsp
Kiwi :
I thought Niacin Trial failure was known 2 years ago? Please see link. TIA.
http://www.medscape.com/viewarticle/776483
I'll chip in $100 (via paypal to Biobill's Swiss acct.?) for such a good cause.
JL, would you please explain one last time why "Vascepa is far from an ideal drug for a generic to target"? All I see is ton of ANDA filings despite less than blockbuster Vascepa sales. TIA.
no-mo, does it mean the Judge is corrupt too and start leaking info. to his hedge fund buddies?
Remember, "Right is on our side"! Happy July 4th everybody.
Bio, what a welcome change of altitude compare to a week ago. Keep up the good work!
Bio,google Matthew Herper and Mary Parks. Herper and AF are tight.
Thanks STS. Best luck and health to you. The following link may give you a few laughs :
STS, what's the symptoms of tooth infection. I might have it also. TIA.
No! Can't take it anymore. No more news regarding superior and beneficial therapeutic effect of EPA please.
Signed,
Coleman, Parks of FDA
STS, I hope you remember ACCORD and AIM-HIGH trial patients' medium TG level is quite healthy. However, the high TG subgroup of trial patients did show a CV benefit of over 33%
Factors that point to R-I trial success :
1) JELIS
2) ACCORD and AIM-HIGH subgroups analysis
3) Latest US and European APOc3 research
Pls. add anything you can think of.
Factors that point to R-I trial failure :
1) trial data gathering screw up
2) trial under-powered which led to time extension
Pls. add anything you can think of.
At this point, probability of R-I trial success is at least 50%, IMHO. Hence, the expected value of a multi-billion dollar drug like Vascepa is at least couple billions, no?
Alt, would you rather take a pill that lower your TG and APOC3 naturally or take an injection (by ISIS) that manipulate your genes with unknown side effects?
I try google Matthew Herper and Mary Parks. Seems like Mr. Herper like to cover Ms. Park a lot in his stories. I believe Mr. Herper and AF know each other well.
FDA's insistence on TG<500 shouldn't be treated is harming American's health :
http://www.nejm.org/doi/full/10.1056/NEJMoa1308027
Chica, you may be able to lower your copay to $9 if you use the coupon.
https://vascepasavings.com/