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Or.... since he is hopping back in for a LONG position, why not spread FUD in the meantime to try to influence some uniformed suckers to sell and to deflate the PPS, so that he could get in cheaper.
I agree with you BB one hundred percent. FDA violated the SPA guidance. Anchor should have been granted already. And all the waiting time to reach the RT results is costing the patients their lives and money. We may not be surprised to see Tg plays a major role in causing CVD at the end. Harvard's huge computer code predicts this we all know. FDA is going to save face by siding with us in our ITC suit and the pps will rise to our satisfaction pretty soon and lot of us will forget the Anchor debacle and move on, imo. This is very possible to commence in a few weeks.
BB-
This post is a good example for my statement, you did not cite any law / regulation to support your view.
I hate to admit it, but I don't think that HD has lost an argument here, yet.
I just checked with my pharmacy and I'm now officially a member of the Vascepa taker club. Rx is ready for pick-up!
UFO
G- The fact the FDA had the Ad Com and made the allegations and then publicly foreshadowed the rescindment of ANCHOR violated the APA. The FDA has guidance documents to address such procedures, not using those documents is arbitrary and capricious. My "statement" the FDA violated the APA by publicly rescinding a SPA without using the set guidance documents approved by the agency is fact. Had the FDA used the guidance documents a type A meeting would have been scheduled prior to Oct. 16th 2013 ANCHOR rescindment SPA Ad Com. The exact law is the FDA can not deviate from set guidance documents because they feel they could get away with it, this is arbitrary and capricious. The damages are AMRN stock being destroyed.
Google APA. Read Oct. 16th Ad Com. Make a proper conclusion the FDA acted in an arbitrary and capricious manner with the method used to rescind ANCHOR SPA. The actual SPA rescindment right or wrong is immaterial, the method damaged stakeholders.
BB
Stac, it sure seems very reinforcing that R-I is going to deliver. A must read for all on this board and our friends and family. Thank for the original post.
I assume you are "going to hope back in" for the ride down, correct? I mean, obviously from your posts you don't think RI will be a success, so I assume you will be shorting, right?
I already sold at $4 ( bought at $1) ... but I am going to hop back in .....
LOL he copied my earlier post here..
so ... potentially, reduce-it is many trials in one.
This was some impressive reading. What JL has stated for over 2 years. From Jackofalltrade on Stocktwits on 10/3/17
https://www.karger.com/Article/Pdf/479391
BB-
stacs,,,,
Quote: "How worse than 0.6% can it be? 2%? 3%? T would still be a RRR well above 50%...
Quite onesttly I am scratching my head as to why this trial has not been stopped yet."
That's very easy to answer... The RRR is going to be very high and is not the issue...The issue is the number of events needed to show strong statistical benefit in the thirty plus data points the trial is looking at...
Even though high RRRs lower the number of events needed for statistical significance; all these additional data points are fractions of the total number of Primary and non primary events and some of the data categories are "small fractions"..Since most of these data points reflect clinical outcomes if they show strong statistical significance this could be used to justify new indications for Vascepa...So it is important to collect as many events as possible and that means running the trial as long as the trial design allows..
":>) JL
...that's a meal in itself!
Their was a company I was invested in years ago that efforted to remove all EPA from fish oil for the purpose (mainly) of getting into baby formula. They were Martek (MATK I think). They used algae as their source. I forget who bought them out.
s-
If you are done with Miss January, February, ... June, but you are still active and Miss July, ... December are fine with it, will you end the night or will continue?
JT, Q4 2015 CC
G- When you can’t win the arguments on facts you tend to switch to personal attacks...reminds me of how the FDA acted with ANCHOR Amarin SPA appeal, it’s probably why you think it’s OK for the FDA to act in such a manner. Same with JL, this passive aggressiveness is very common among surgeons.
Jason/BB
Thanks HDG and Raf for the discussion.
HDG...
Thanks....We are both on the same page...
":>) JL
JL if the EPA/AA ratio in RIT are dose to match those in Jelis, then are we supposed to see a 2.8% MACE rate over 4.6 years, ie 0.6% per annum for the RIT treated arm? That would be quite an improvement considering that RIT composite rate is 4.8% so far.
How worse than 0.6% can it be? 2%? 3%? That would still be a RRR well above 50%...
Quite onesttly I am scratching my head as to why this trial has not been stopped yet.
A senior citizen called her husband during his drive home:
"Jason, I just heard on the news that there's a car going the wrong way on the highway, Please be careful!"
Jason said
"It's not just one car. There’s hundreds of them!"
I take 8 a day some times more!
G & JL- You are both very wrong with your assertions the FDA acted within the confines of the APA.
JL-
Thanks.
As it is started to be scientific, this post is definitely not a counter argument, just points for consideration.
Babr...
Does EPA's anti inflammatory actions increase the risks of infections...
Great question...We all know what happens in AIDs and we know about the "Bubble Boy"...
I don't know the answer...This will be one of more than the thirty data points looked at in R-I...
My guess is the effect is going to be fairly small...
First an anecdotal story..About a year and a half ago I was stung by a hornet on the palmar side of my left middle finger (right through my golf glove) at the middle phalangial joint...By the next day my finger and hand blew up despite the fact I was elevating my hand. The next day my hand was so swollen I knew this was a serious infection and I headed into Florida Hospital...I was seen in the ER, had blood drawn including cultures and was treated with IV Vancomycin..(MDs in the crowd know what that means)...I returned for twice a days for three more days...And the swelling went down...Of note on my intitial admission my CRP was over 9.
I have had no similar episodes..
The EPA/AA ratios in the R-I are dosed to match the treated arm in JELIS..In JELIS there was no concern over higher infection rates. Steroids pretty much destroy the COX and LOX receptors and end all functions both good and bad...EPA actually promotes inflammation, just not as much as AA.
":>) JL
"FDA invalidated the SPA on the grounds of three CVOTs"
When this SPA was granted, these studies were underway (I stand corrected if my timing is off but I'm pretty sure that it is correct). Were there no discussions between AMRN and the FDA on what the FDA would do if these studies do not show undisputable proof of effectiveness of TG reduction?
HDGabor...
Excellent post...agree with all points..
Quotes:
1) "The FDA (requesting R-IT result instead of ANCHOR), did not set the bar so (too) high, they set the bar on the correct / right level ... to confirm clinical effectiveness clinical outcome is necessary."
2)"I did not see any sign that it was personal against Amarin or requested / pressured (sanctioned) by any entity (commercial or governmental)..
The above quotes reflect what I believe is factually true..And should have been the correct course of action. However, IMO, the SPA was (appeared to be) flawed because it made the assumption that trig lowering would lower CVD event risk..An assumption that was held by many MDs in the CVD field..If this "assumption" was indeed correct then the "new science" clause in the SPA rules would have required "New" (dated from the commencement of the SPA) scientific evidence that trig lowering would not lower CVD event risk. So at the very least the SPA was poorly constructed and ambiguous.
FDA invalidated the SPA on the grounds of three CVOTs...ACCORD, AIM-HIGH, and THRIVE...all of which according to FDA, showed that Trig lowering, did not lower CVD risk...Well to say that was creative on FDA's part is putting it mildly..None of these trials were focused on trig levels and their effects on CVD event risk...All of trials were failures on some level and actual subset of moderately high trigs in one trial did suggest trig lowering might reduce CVD risk..
IMO FDA did use these three trials as a ruse to renege on an SPA that never should have existed..The hard truth is there was/is only shaky proof that lowering trigs will lower CVD event risk and there was/is only shaky proof that EPA would lower CVD event risk in mixed dyslipidemia..And what other reason would there be to give Amarin a label indication for the 35 million patient indication unless it was that EPA lowers CVD event risk...
So like it or not...FDA might have used some leger-de-main and played fast and loose with the facts...but they did the right thing...We need proof, clinical proof that EPA lowers CVD event risk and that proof will be given by R-I...
":>) JL
I'm currently taking three of those a day in the UK, as the best proxy for Vascepa. About USD 35 for 60 capsules. Good idea?
PharmaEPA 'Restore' Label: Is Pure EPA no DHA. O3 components.
___________________________
FAT 1150 mg
Saturated FAT 15 mg
Polyunsaturated FAT 1120 mg
Monosaturated FAT 15 mg
___________________________
Omega-3 rTG fishoil 1150 mg
EPA 1000 mg
DHA 0 mg
___________________________
Vitamin E 10 mg
Exactly, and has been my opinion for years. It seems President Trump is siding on the side of generics while ignoring the high cost of bringing a new drug to market. I equate that thinking to the situatipn that exist in the rising cost in health care, which has numerous factors associated with these cost. For instance, when using mathematics all values on both sides of an equation must be used to find an accurate result. Healthcare cost will never be completely addressed properly until all issues affecting the rise are conidered. One such example is Tort reform. Another is graft. The lawyers in gov't are resistant to do anything to affect the brotherhood of lawyers. Once you let the wolf in the hen house don't expect to eat a lot of eggs.
i-
I did not say that pancreatitis could not be measured, but the APPROACH study wasn't an event-driven study, the Primary Outcome Measures was "Efficacy of ISIS-APOCIIIRx as measured by the percent change in fasting triglycerides from baseline".
Best,
G
ps.: I could not find more details other than "APPROACH is a randomized, double-blind, placebo-controlled, 52-week Phase 3 study in 66 patients with FCS, a rare disease affecting approximately 3,000 to 5,000 patients worldwide ... Volanesorsen-treated patients with the highest documented frequency of pancreatitis attacks suffered no attacks during the 52-week treatment period (p=0.02)" ... zero pancreatitis in the treatment arm and ??? pancreatitis in the placebo arm
d-
Currently not.
Best,
G
JL what are your thoughts in terms of what would happen in situations where we really need that inflammatory response To fight back that virus or bacteria or parasitic infection, do you think this drug is going to increase the rate of infection compared to the placebo ?as it has happens in case of a lots of other anti-inflammatory agents .Even in case of inhaled steroids there is increased rate of pneumonia even with the little exposure to systemic steroids in asthma or COPD.They are probably going to look at this in this study?
Hd, do you invest any other stock beside Amrn?
c-
The principal concern / target (first priority) for patients with severe hypertriglyceridemia, levels of TG 500 or greater (MARINE), is that to get their triglycerides down in an attempt to avoid acute pancreatitis.
An event driven study where pancreatitis is the endpoint would be tough to do, not possible, TG reduction is the correct basis for efficacy / approval.
The only reason to treat patients with TG below 500 is to prevent CVE (a clinical outcome). The science of TG (as a marker of CVE reduction) is mixed, TG reduction (especially as a stand alone marker) wasn't (and won't be by R-IT) confirmed as has a 1:1 relation with CVE reduction.
The FDA (requesting R-IT result instead of ANCHOR), did not set the bar so high, they set the bar on the correct / right level ... to confirm clinical effectiveness clinical outcome is necessary. V - as we think - could be effective against CVE, but it should be proven for approval, promise isn't enough.
Please note: To consider TG as a valid marker (TG reduction will be resulted in CVE reduction) it should be detected with different class / type of drug, since in this case it does not depend on the MOA / etc. of the drug ... TG is a real marker. Until that it is (more likely) a symptom only.
I did not see any sign that it was personal against Amarin or requested / pressured by any entity (commercial or governmental) ... Amarin was at the wrong place at the wrong time. Please note: if they were to sign / get ANCHOR SPA in 2012/2013 they wouldn't get it.
Amarin "forced" the ANCHOR till it makes sense (till OND level), but let go it finally.
I am wondering anybody think seriously, that Amarin / management, which sued the FDA in 2, first in class cases (and won) should go further with SPA appeal ... the case wasn't / isn't winnable, they let it go due to a good reason (and it wasn't something else other tan as I said above).
Best,
G
Perhaps the FDA is approaching many problems the wrong way. For instance, high Trigs is a symptom of a problem. Just because a drug fixes a symptom does not mean that its unique mechanism of action will not solve a problem related to that symptom. So when they state that because two other drugs that address a symptom have no effect on relieving CVT disease doesn't necessarily mean that a third drug which has a long history, by the way, of having a beneficual relationship should be treated in the same manner as those that do not.
So if they made a mistake in issuing the Anchor SPA why did they not eliminate the Marine indication? Science is science, right? That is why I believe the FDA was pressured by some entity and the science they used was faulty. They believed that Amarin would not challenge their decision as long as the Marine trial results were left alone. As it turns out that is exactly what happened. The carrot for Amarin was the RI trial which the FDA thought would reaffirm their decisions. That is why they set the bar so high. Instead it may well blow up in their face.
I stand corrected if I'm wrong, but no where do I see any study that shows that lowering TG reduces chances of getting CVD.
That is not the same as 'people with elevated TG have a greater chance of getting CVD'. Do we know if a bunch of other biomarkers are elevated as well?
Raf Try this ....part deux
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4866746/
enjoy
Kiwi
Excellent results for your parents ...well done
Kiwi
Raf try this
Epidemiological evidence
In the Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis In Myocardial Infarction 22 (PROVE IT-TIMI 22) trial, it was demonstrated that, among patients receiving statin therapy following acute coronary syndrome, an on-treatment fasting TG level <150 mg/dL (<1.7 mmol/L) was associated with a reduction in recurrent coronary heart disease risk versus higher TG levels (Table 1), even after adjustment for HDL-C and LDL-C levels (hazard ratio 0.8; P=0.025).10 A wealth of epidemiological evidence exists, demonstrating that both fasting and nonfasting TG levels are significant predictors of cardiovascular events, even in individuals who have already achieved guideline-recommended LDL-C levels with lipid-lowering therapy.64–68
Table 1
Table 1
Key studies investigating the association between triglycerides and cardiovascular disease
However, nonfasting TG levels are thought to be a much stronger predictor of cardiovascular events than fasting TG levels. The Women’s Health Study (n=26,509) showed that both fasting and nonfasting TG levels were strongly associated with an increased risk of cardiovascular events, independent of baseline cardiovascular risk factors (age, blood pressure, smoking, and use of hormone therapy). However, after adjustment for TC and HDL-C levels and indicators of insulin resistance, the association between fasting TG levels and the risk of cardiovascular events was no longer significant (P=0.90). In contrast, the association between nonfasting TG levels and cardiovascular risk remained strong even after adjustment for other lipid levels and markers of insulin resistance (P=0.006).67 Likewise, two prospective cohort studies using data from the Copenhagen City Heart Study found that the cumulative incidence of cardiovascular events (ischemic stroke, MI, ischemic heart disease) and all-cause mortality were strongly associated with increasing nonfasting TG levels (all P<0.001) (Table 1). That being said, these associations were not adjusted for other lipid parameters.66,68
A number of studies have found that the association between plasma TG levels (both fasting and nonfasting) and cardiovascular risk is often attenuated once adjusted for other lipid parameters, including HDL-C and non-HDL-C. An analysis conducted by the Emerging Risk Factors Collaboration, which included data from 302,430 individuals from 68 long-term prospective studies, demonstrated that there was a significant and stepwise association between fasting and nonfasting TG levels and CVD risk. However, this association was no longer significant after adjustment for HDL-C and non-HDL-C (Table 1).64 Likewise, in a combined analysis of the Incremental Decrease in End Points through Aggressive Lipid Lowering (IDEAL) and Treating to New Targets (TNT) trials in patients achieving low LDL-C (<70 mg/dL [1.8 mmol/L]), CVD risk increased incrementally with increasing on-treatment fasting TG level, with patients in the highest quintile experiencing a 63% higher rate of cardiovascular events than those in the lowest quintile (P<0.001). However, this association was also attenuated (P=0.044) after adjustment for HDL-C and apoB/apoA1 (Table 1).65 Elevated TG levels are closely associated with higher levels of non-HDL-C and apoB and low levels of HDL-C,2 and this may explain why this association is weakened after adjustment for these parameters.
Elevated remnant cholesterol levels, which directly correlate with elevated levels of TRLs, have also been shown to be associated with CVD. Using data from 73,513 subjects, Varbo et al30 found that every 88.6 mg/dL (1 mmol/L) increase in remnant cholesterol was associated with a 2.8-fold increase in CVD risk, independent of low HDL-C.
Update, I found dad's results from 6 months ago:
Mom (63) TODAY
LDL 114
HDL 61
TG 98
Dad (69) TODAY / 6 MONTHS AGO
LDL 80 / 72
HDL 36 / 32
TG 109 / 289 (was nearly 500 2 years ago)
VLDL 22 / 58
Doctor's quote to my mother: "I've put over 100 patients on Vascepa since your son sent me that literature, please thank him"
Parents just received blood results. They have been on V for 2 years (went from 2g to 4g 1 year ago). I'm too lazy to dig up their exact previous results, so I'll post dad's from memory. I posted them before, so if anyone is interested in digging them up, please do so. The current numbers are amazing:
Mom (63) only on V:
LDL 114
HDL 61
TG 98
Dad (69), on statin & V:
LDL 80 (was over 250)
HDL 36 (was in high 20s)
TG 109 (was in high 480s)
VLDL 22
Raf U really can do your own DD
https://cardiab.biomedcentral.com/articles/10.1186/s12933-014-0135-6
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0123521
https://www.ncbi.nlm.nih.gov/pubmed/24436475
https://www.ncbi.nlm.nih.gov/pubmed/26892957
Thats from a quick scan
Kiwi
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