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Either show any proof (not a "DISCUSSION") or quit FUD'ing.
You mentioned bleeding. There is absolutely no evidence of such. Why not mention eyeballs popping out or growing a tail?
Bleeding data is indisputable.
"no evidence of increased risk of bleeding with use of n-3 LC-PUFAs was observed."
I agree the bleeds data is disputable. Again, my point isn't that I know bleeds will be an issue in the Vascepa ph3. My point is that it is dangerous to dismiss it as a risk - it shows up in both Jelis and in the randomized trials that Vascepa submitted for approval. Per FDA's Vascepa Medical Review:
26M people worldwide suffer from heart failure. Increased EPA/AA ratio is linked to more than 50% death risk reduction. Shouldn't all of them be on EPA?
http://www.sciencedirect.com/science/article/pii/S1071916416300628
https://www.escardio.org/static_file/Escardio/Web/Congresses/Slides/Heart%20failure%202015/1183%20-%20The%20global%20burden%20of%20heart%20failure.%20-%20Martin%20COWIE%20(London,%20United%20Kingdom).pdf
North:
I am sorry to hear about your DM1. I dont know if you are familiar with viacyte. They have two systems in research studies to treat DM.1. PEC Direct and PecEncap. Both systems use pancreatic cells encapsulated in a an envelope.
The PEC Direct requires immunosupression to allow the stem cells to survive its already in a Phase 2 or 3 study.
The PEC Encap will be amazing if they can optimize the capsule. Basically the pancreatic cells will function like your own pancreas but remain 'hidden' from your immune system (no immunosuppression needed ) . This will be an absolute amazing quantum leap forward in the treamtent of DM1. If it works no meds no monitoring and perfect BS control for two to three year at a time- then simply go in and get your capsule replaced in a brief in office procedure
I think this company is a tremendous investment but unfortunately is privately held
I wish you Health and courage in your challenges
Yes didn't take long to start tapping into it as I predicted!
The sales are a bit disturbing running into the finally! Not a vote confidence!
I think Ketchum wanted a new car...
EPA Drug Initiative should open an on-line Pharmacy for just "Vascepa" prescriptions. It could specializing in shaming payers to reimburse.
JMO
BB
Hi North-
I would be happy to followup your communication to JT; your story is amazing and you should be in the first "V" commercial. How about a 30 second add during the next Super Bowl? ;) --BB
How many fricken degrees to you have? You make the rest of us look dumb and unmotivated.....
Hi CB- A.fib while it can be a "side effect" of DHA is generally a more survivable disease state than NASH. So under the assumption of risk this could be a viable alternative for Epanova as opposed to competing with "V' for the cardiovascular space.
I think it's a very bad idea for AZN to attempt to "win" market share for the cardiovascular space with Epanova due to the massive diarrhea side effects which would most definitely decrease patient compliance; increasing cardiovascular overall expense for the entire healthcare system is counterproductive.
BB
Planned sale of RSU. Part of comp plan.
Isolated insider selling of a partial position doesn't really tell us much. There were 2 other insider purchases in the same timeframe for an offset. Why did Ketchum sell 63k shares? "Because he needed the money."
UFO
iwfal to quote you
"
certainly nowhere near 'proven "
Correct ...speculate all you want ... so please explain to the board , the meaning of P = 0.18
Then consider Omega was a 1 gm trial of ( EPA/DHA ) ? for 1 yr and the calculate the probability of this having any predictive value on a trial run for 5 yrs with only EPA .
If the P value was 0.18 for 1 yr on EPA/DHA at 1 gm ....what would your confidence be in guessing the P value for mortality , for 5yrs of 4 gm , EPA only
How about close to zero ( confidence )
Kiwi
That is one hypothesis that could be proven true by proper administration of a properly timed test to enable determination of presence, or absence, of insulin in my system after ingestion of food.
I have not arranged for such a test with either my PCP or endo with whom I consulted in May.
Whatever any content or amount of insulin secreted by any organ in my body presently is extant, it is not enough to permit normal activity with no injection of insulin, per an experiment(test) I ran myself in May or June.
One morning, I had my normal breakfast w/o injection of prescribed insulin of any kind. I tested my bg values every 1/2 hour. My bg values(measured by JNJ One-Touch system in usual manner) did not rise more than expected amounts(beyond the normal bg value extant before breakfast) for several hours, but then began to rise rapidly. I controlled that rise by injection of appropriate amounts of insulin.
I theorize(surmise) that a much sooner rise in bg value had been controlled or suppressed to an unknown degree by the usual injection of 4 units of Humulin N the evening before the test began.
I have chosen not to run the same test as above, but also omitting that evening dose of Humulin N, to see what would happen.
The jury is still out on your question while I continue reduction of injected dose of insulin, as described in last paragraph of my previous post.
iwfal re Omega
total mortality, 4.6% and 3.7% (P=0.18)
Come on ...get serious
Kiwi
Rose .. doubt if anyone in Mgt can buy large stakes in the open market , this close to final readout .
SEC would be all over them
JMO
Kiwi
MJ, there could be many reasons someone sells, there is only one reason they buy.
Having said that, how much more calming for us would it be if there were no sales and a bunch of purchases. As Whalatane pointed out, it is a double blind study and no one knows for sure.
HDG and if U are right by Oct 20 th .... a bottle of Cloudy Bay Cab ?
Kiwi
Iwfal. Total deaths is such a red herring ... and u should know why
The bleeding risk has been analyzed to death ... don’t think it exists
Correct. The trial is double blinded. Anyone who states with certainty the RRR on final readout at this pt ... is a fool
JMO
He didn’t get J L’s memo ..
It’s a 10b plan sale ... just covering his bases in case .., god forbid ...JL is wrong
Kiwi
North. Please post your Lipid panel EPA/ AA etc when U have results
What’s your opinion on the I T C accepting Amarins case and having jurisdiction
HDG feels it’s a done deal ... but since I like informed second opinions ... what say yee
Kiwi
Another form 4 selling by Kitchum today. What gives all I ever see is sales. If this is a home run why are they dumping stock
north40000, Are you saying that you believe your use of Vascepa may have resulted in your pancreas producing (at least some) insulin?
What are the thoughts on the Scientific Officers sell of stock? Approx. 63k shares...Steven Ketchum.
JL and others: I sent the following via PM to iwfal at dinner time yesterday. He responded with an interesting insight that I did not expect that I will not repeat here.
He can explain later if he wishes.
*****************************************
I sent the following letter to John Thero, CEO of Amarin, in early August 2017. I received no response from anyone at Amarin, nor did I expect one.
The letter contains certain "biomarker" data for me. I thought you might be interested in the "facts" presented in the letter.
"Good morning, John
"My name is [XXXXX]. We own [XXXk] shares of Amarin. I am a Washington, D.C. patent attorney with 25 years experience in patents in Executive and Judicial branches of U.S government(1961-1986), as well as 30 years experience in patent litigation(1986-2016), testifying and consulting as an expert witness in ~ 150 patent infringement suits. I am the Founding Editor of the Federal Circuit Bar Journal. I have degrees in chemical engg from Northwestern University and Princeton University, conferred in 1959 and 1962. I was diagnosed as a Type 1 diabetic in 1957, 60 years ago.
"I now have 4+ years experience with Vascepa that you, Dr. Granowitz, and your patent attorneys may find of interest. Further details are available. I summarize below:
"The EPA/AA ratio is becoming widely recognized as a marker for inflammation in the CV system---my 2016 value of 1.3 is particularly good, probably better than the vast majority of the U.S. population. My 2017 EPA/AA ratio is even better, 1.67. My doctor termed my lipid profile as "excellent," and my cardiovascular risk as "optimally suppressed." Now 80 years old, I have no walking or arthritis difficulties, or other known or common T1 D side effects.
"My DES disappeared within a week of initial Vascepa dosing in April 2013. It remains entirely gone today.
"Below are the 2016 and 2017 lipid panel marker values for me. I have been prescribed 4 capsules/day of Vascepa[an oral capsule containing 96%(1 gram) of an omega-3 fatty acid known as EPA, or icosapent ethyl], Off-label, since 4/1/2013. Family history of CVD and T1 D are in my background. My father died in 1959 from a heart attack at age 51, experiencing his first heart attack 10 years earlier at age 41; his 3 sisters also died from CV events at a young age. I was told that T1 Diabetes is present in relatives in Norway who I never met.
"Medications: Generic Zocor = 40 mg dose > 20 years. T1 diabetic since 1957, 60 years duration. 20 year prescription for 32 units LLY NPH HumulinN U-100 and 7 units of LLY Humalog U-100 with breakfast; 4 units of HumulinN at bedtime.[BP medications and vitamins C, D and E omitted]
"2016 April HbA1c = 6.5; FBG= 111 mg/dL [About the same in April 2017]
2016 Total cholesterol = 144 mg/dL [2017: 125 mg/dL]
2016 LDL-C = 70 mg/dL [2017: 57 mg/dL]
2016 TGCs = 63. " [2017: 60 mg/dL]
2016 HDL = 61. " [about same in 2017]
2016 VLDL = 13. " [about same in 2017]
2016 C-reactive protein = 2.2 mg/dL [2017: 1.4 mg/dL]
2016 APO B = 60 mg/dL; [2017, not measured]
2016 Lp-PLA2 = 216, termed very slightly elevated;[2017, not measured]
2016 EPA/AA Ratio = 1.3; [April 2017 value is 1.67]
2016 Omega-6/Omega-3 ratio = 1.8; [omega-6/omega-3 ratio = 1.6, April 2017]
2016 EPA = 7.0% ; [7.8%, April 2017]
2016 AA = 5.3%; [4.7%, April 2017]
2016 DHA = 2.1%;
2016 Omega-3(EPA + DHA) Index = 9.1%, optimal > 3.2%{April 2017 Index value is 10%] "
***********************************
"Another item that may be of interest, John, in light of my T1 D history. Over the past 2 years, I have slowly reduced the breakfast amount of insulin I had taken daily for many years; now that reduction amounts to ~ 25%[32 U of Humulin N--->24 U; 7 U Humalog--->5 U]. I have done so to avoid the more frequent, serious hypoglycemic episodes I slowly, but surely, had begun to experience. The following excerpt from my April 2017 letter to my PCP, and certain April 2017 articles, may explain why....you may already be aware of the articles:
'You and I have wondered for some time, particularly the past 4 years or so, how my fasting blood sugar levels and HbA1c levels have remained so well maintained.
'The following articles[note the longer one is authored by Chinese researchers] from this past week may present the reason...the 1st link is a summary of the 2nd link:
http://www.medicalnewstoday.com/articles/316756.php
http://www.jci.org/articles/view/87388?key=bbb2df2018c8c18d1e0b
https://www.researchgate.net/profile/Marta_Garcia-Contreras2/publication/305676844_Combination_high-dose_omega-3_fatty_acids_and_high-dose_cholecalciferol_in_new_onset_type_1_diabetes_a_potential_role_in_preservation_of_beta-cell_mass/links/5798cae008aed51475e87894.pdf
'I recall from initial consultations with you, early in my 1st visits as a patient 20 years ago, you thought it was worthwhile to explore whether my pancreatic beta cells, islet cells, were still producing at least some natural insulin. Whatever blood test was performed came back with a totally negative answer to that hypothesis, as I recall.
'I think it is time, in light of the wake-up call provided by the above articles, to again investigate that hypothesis, inasmuch as I have been taking the off-label prescription of 4 capsules/day of Vascepa[each capsule containing 1 gm EPA or icosapent ethyl] for the past 4 years. You will recall we have discussed my serious hypoglycemic episodes occurring over the past year or 2, even with reduced dosages[by 25%] of HumulinN and Humalog that I have been taking vis a vis the prescribed levels of each I had taken for years.
'I would appreciate an opportunity to talk with you re the above, as well as what further investigation is needed now to determine status of islet cells. Do we have frozen blood available/preserved from past visits in the last 4 years to determine progress, if any, with time as the variable, of my islet cells? I am thinking particularly of blood draws in 2013[before any Vascepa to get a baseline] and each subsequent year, especially 2017.[The answer was no]
'I may present a rare case....a "clinical trial" of one T1 Diabetic. Because the Reduce-it Phase 3 clinical trial being conducted by Amarin, the sponsor, remains randomized and double-blinded as to the company, but not the IDMC, we do not know whether T1 Diabetics have been enrolled in that trial. I do not think they are excluded.'
"At this time, John, neither my present PCP, nor a well known, metro-D.C. endocrinologist that I consulted in late May 2017, is willing to express the opinion that Vascepa is the cause of my 25% reduction of daily insulin dose that I have been forced to experience. Both agree there is a correlation. Both are former NIH research physicians. The endo has no T1 Diabetics that also take Vascepa in his extensive clinical practice.
"In light of facts above, you and patent counsel may wish to explore filing a patent application regarding the use of Vascepa in treatment of T1 diabetes, if Amarin has not already done so. I am aware of one published Amarin application relating to diabetes generally. I have data that documents my use of Vascepa[EPA] in Type 1 diabetes prior to the publication date of the above articles.
"My wife and I travel to Europe beginning this coming Monday for vacation---Northern Italy, Switzerland, ultimately Amsterdam, and return to Washington on Saturday, August 19. Should you find it desirable, I am available for consultation with Amarin anytime."
Since that letter to John Thero in August, I have further reduced the amount of Humulin N in the morning from 24 U to 22 U, and Humalog from 5 U to 4 U.
I plan to continue attempts to reduce insulin dose levels in the future---time is the variable, and FBG levels remain in acceptable ranges so far.
I will have further lipid panel values available next week from blood draw on Tuesday this week.
iwfal...
Your posts tell me you don't know a lot about EPA, the scientific or clinical literature. This gap in knowledge is clear when you make comments suggesting there likely will be enough adverse events to counter any meager benefit the drug will show...This tells me and everybody on the board that does know a lot the subject, that you are just spouting wind..
Why don't you expand on the bothersome side effects?
There is ample information, direct and indirect, that EPA does and will lower CVD risk...JELIS is something you need a couple of weeks worth of study and reflections on...Maybe you should familiarize yourself with some of the population studies and read Dr. Bernard Sears and learn about eicosanoids .
I do not think there is any chance the RRR in the PE is in doubt...JELIS curves which track the secondary prevention cohort which is very close to R-I show that the RRRs do not increase to any meaningful degree after a couple of years. This means if the PE RRR was very weak at the 60% interim it is very unlikely its going to get stronger over time. And continuing the trial is not likely to resurrect a dead PE. Actually it makes more sense to continue the trial if the PE RRR is very strong...because there is a greater likelihood of having some of the smaller subsets (the additional datapoints) to show strong significance...If the PE is marginal or disappointing there is very little chance, as you imagine, that any of the lesser data points are going to be a big surprise..The reason to continue the trial is not to raise the RRR...The reason to continue is to get more events.
":>) JL
Do any of AMRN's patents deal with EPA and DES?
Because this combo drug would contain DHA would it not also put patients at risk for AFIB? This sounds like (another) not very bright AZN decision.
Sam, as always, thank you for sharing.
AZN moving Epanova out of the cardiovascular space?
Patent combo for Epanova & SGLT2 inhibitor to treat NASH
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=2&f=G&l=50&co1=AND&d=PTXT&s1=%22icosapent+ethyl%22&OS=%22icosapent+ethyl%22&RS=%22icosapent+ethyl%22
He didn't excuse the missed P value. He said he is so confident in it, he doesn't consider that even an issue, due to his confidence in it.
Sorry but it is not a theory but fact - as shown by recent CVOT's.
BB-
Meanwhile, as I wrote ..., I think the ITC has jurisdiction and I do not think that Amarin will fail in case of an investigation, but I do not have any idea what you mean by "FDA can’t afford an ITC failure". None of the outcome of the ITC case (no inc., inv. but no "ban" inv. and "ban") will affect the FDA.
G—?I don’t think ITC action will fail, the FDA can’t afford an ITC failure. If we are wrong we disagree what would happen.
BB
BB-
It looks like you accepted finally, if ITC case will fail (I do not think), Amarin could not force / sue the FDA to act against the "DS".
r-
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