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If true, that's great news, i.e., no generic challenge until NCE lawsuit is settled and the 30-month stay clock get postponed until then. I believe we get another 30-month stay if ANCHOR is approved and an additional 30-month stay if REDUCE-IT is successful.
In case you are interested, that's how our fearless leader looks like :
http://www.irishtimes.com/business/sectors/health-pharma/amarin-takes-legal-action-against-fda-over-patent-protection-for-vascepa-1.1707441
Is there a link for the generic challenge you mentioned? TIA.
Complete recap that STS mentioned earlier :
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2014/02/amarin-sues-fda-after-the-agency-denies-5-year-nce-exclusivity-for-vascepa.html
Other than Jupiter trial, are there any trials that backup the statement "The problem with add on therapy to a statin is the reduction in CV events with a statin is a high number already." TIA.
Low levels of high-density lipoprotein cholesterol (HDL-C) and raised triglycerides, affecting millions of patients worldwide, are strongly linked to significantly increased risk of coronary heart disease (CHD):
http://www.news-medical.net/news/20090903/Low-HDL-cholesterol-and-high-triglycerides-linked-to-increased-risk-of-CHD.aspx
From the article :
"In the past three decades in the U.S., while the prevalence of abnormal levels of LDL-C has decreased, the prevalence of combined abnormal TG (greater than or equal to 150 mg/dL) and HDL-C ((less than)40 mg/dL) has doubled and the prevalence of elevated TG (greater than or equal to 150 mg/dL) has increased five-fold.(5) Elevated TG ((greater than)150 mg/dL) is also common, affecting about 50 percent of adults with prior CVD.(6) "
Seems like Bove's $18 target take 80% warrant dilution into consideration.
Am I correct to assume that the CP denial and Vascepa's NP exclusivity decisions are related since they were pretty much determined on the same day? From the FDA's perspective, the CP denial should strengthen the case that Vascepa is not an NCE or Vascepa's non-NCE status should explains why the CP should be denied. However, when I read the reasons for the CP denial, it actually strengthens the case that Vascepa is an NCE. Is the FDA screw up or what?
The VA-HIT study also showed sub-group benefit for TG>200 :
http://www.nejm.org/doi/full/10.1056/NEJM199908053410604
VA-HIT study, see link :
http://www.nejm.org/doi/full/10.1056/NEJM199908053410604
John, thanks for responding. You missed my point. TG between 200-499 has always been required to be treated even according to the FDA. Otherwise, why the the heck it entered into ANCHOR SPA with Amarin? So all of a sudden FDA said TG between 200-499 don't need to be treated anymore, fine, it needs to back it up with something concrete.
John, what you mean by 'no "proven benefit" of treating Trigs below 500 right now'?
Well, 99% of clinicians out there would still treat patients with TG between 200-499. Worse, clinicians continue to prescribe fibrates, niacin and Lovaza to treat those patients despite laundry list of side effects and proven failure of outcome trials. Before Oct 16, 2013, FDA's thinking was TG between 200-499 should be treated. How do I know? Otherwise, FDA shouldn't have the need to design the ANCHOR SPA with Amarin back in 2011 and accepted the ANCHOR sNDA at end of 2012. Moreover, even FDA's own website says TG between 200-499 needs to be treated, LOL! So to not treat patients with TG between 200-499 from now on, the FDA needs to put forth a bulletproof theory to explain why TG between 200-499 shouldn't be treated because American lives and health is on the line here. FDA can't use ACCORD, AIM-HIGH or THRIVE as a valid theory because the test subjects of those trials have medium TG much below 200. In fact, the subgroup analysis of those trials further validates that TG between 200-499 needs to be treated. If I explain all these to a 10-yr old, he'll be able to comprehend my reasoning, but not the FDA.
John, can you name other companies that are now facing the same new "Prove It" mentality of the FDA? TIA.
The following link is quite interesting :
http://www.goedomega3.com/clinical-studies.html
I am reading a printout of page CO-73 of Amarin's ADCOM presentation (sorry I don't have the link). You can see the blue line starts to dip below the pink line and if you extrapolate the blue line further out, the gap between the blue & pink line would be even wider. I am hoping the Vascepa ARM of the R-I trial have already reduced quite a few MACE causing the primary events to date falling below the projected rate.
Confirm something we already know :
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2664115/#__ffn_sectitle
Dr. Hiatt did a terrible job of explaining himself :
http://www.nejm.org/doi/full/10.1056/NEJMp1313866#t=article
Scripts from last week, thanks to homebuilder from yahoo msg. board :
TRx 6177 v 5953 up 3.7%. NRx 2683 v 2485 up 8%. Lovaza TRx 82385 v 85919 DOWN 4%. NRx 31197 v 32069 DOWN 2.7%
For someone late to the party like me, which is a better buy now, FNMA or FMCC? Seems like historically FNMA always trades at a price premium over FMCC, until recently. Does that mean FNMA a better buy than FMCC now? TIA.
Great point Zip, thx.
BioChica, I pasted the REDUCE-IT stat. from another poster for your info. :
"REDUCE-IT is powered to show a 15% reduction of MACE in V vs pbo with a proba of 90%. It means we need 1612 events.
At the end, if V shows a reduction of 15%, we will have 871 events in the placebo group and 741 events in the V group, so a difference of 131 events between both groups.
Let's imagine the efficacy of V would show a 20% reduction of MACE. It means that to show a difference of 131 events, we would only need to have 1180 events: 656 in pbo group and 524 in V group. This would occur in July 2016.
With an efficacy of 25%, 920 events would show a difference of 131 events between the 2 groups (526 in pbo vs 394 in V group). This would occur in Dec 2015.
With an efficacy of 45%, 523 events would show a difference of 131 events between the 2 groups (327 in pbo vs 196 in V group). This would occur in Dec 2014!"
Nuts, your credibility was shot once you mentioned Niacin in your earlier post. You only get one chance for first impression.
Zip, great analogy. It makes me chuckle a bit, but it's kind of sad when you think about it.
Nuts, your Niacin comment earlier and now Lovaza, enough said and case closed. That's why the less you said the better. Goodnight!
9 out of 10 might work (I doubt it), but 9 out of 10 people are too lazy to diet or exercise even they are obese or have lipid issues. I don't understand why you still choose Niacin even though it had already failed its outcome study, AIM-HIGH and THRIVE, and proven to cause severe AE in those trials. As a patient, I just want more "tools" in doctors' tool box to treat patients with lipid issues. Perhaps 10mg Lipitor + Vascepas is more effective than just 80mg Lipitor for some patients (e.g., less side effect). Without ANCHOR, doctors will have less to work with to the detriment of patients and not the FDA.
Nuts,
If you tried diet and exercise and your TG level is still 450, what will you do?
Nuts,
What is the "public health concern" w.r.t. Vascepa that FDA has in mind?
Nuts,
If we have POSITIVE interim analysis results, then all is golden like in ICPT. The $64,000 question is what can be done in the interim till we get POSITIVE interim analysis results which is at minimum 18 months away.
I believe FDA (maybe just Coleman, Parks and their supervisors) want to make sure Amarin do not get ANCHOR approval, due to BP influence. A 9-2 ADCOM "no" vote is not sufficient to reject ANCHOR because Amarin did everything asked to be done according to the SPA. As a result, the only out for the FDA was to rescind the SPA. Otherwise, FDA could just issue a CRL without even rescinding the SPA. Therefore, if we get SPA reinstated (big IF), the minimum we get will be label expansion. However, I am sure FDA will try to delay it as much as possible so that BP can continue to benefit from the whole fiasco.
Twice a day (right after breakfast and dinner), 2 pills each time.
Never felt better.
Is that why Lovaza does so well?
http://www.nytimes.com/2013/12/17/business/glaxo-says-it-will-stop-paying-doctors-to-promote-drugs.html?_r=0
Thanks Chas. If Dr. sears is truly genuine to his patients and followers, he should be the chief spokesman for Vascepa.
That's because it's cheaper and easier to source EPA/DHA mixture than pure EPA, hence increasing profit margin for products he try to sell. Note that the AA/EPA ratio Dr. Sears is advocating has no DHA component in it. I can't imagine why he is still pushing EPA/DHA mixture instead of Vascepa other than profit motive.
Interesting read on TG/HDL ratio as a CVD risk predictor :
http://www.cafepharma.com/boards/showthread.php?p=4723943
ACCORD, AIM-HIGH and THRIVE patients' TG/HDL ratios were just too low to show much benefit.
Interesting read about statins :
http://www.forbes.com/sites/larryhusten/2013/03/01/bad-pharma-and-the-statin-wars/
Coleman and FDA should know the only reason to take Antara (Fenofibrate) is to reduce CVD (just like he claimed the only reason to take Vascepa for 200-500mg group is to reduce CVD), but the FDA still approved it even though the ACCORD trial failed its outcome study. Why FDA approve a drug that failed CVOT already and with a laundry list of side effects? I would like to see their risk/benefit analysis on that one.
FDA requires removal of certain restrictions on the diabetes drug Avandia : http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm376516.htm
GSK sure seems to have a very good relationship with FDA, in fact too good to pass the smell test.
The new "scientific" evidence must occur after the "clean" 74 day letter but before Mary Park's preparation for the briefing document, right?