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The ER CC is on Wednesday, August 1st.
Well here we go new 52w low. Stop losses are being collected.
Good summary write up on Amarin vs ITC case.
"Final Thoughts
The Federal Circuit Court of Appeals’ decision is not expected until late summer 2018. Despite the somewhat narrow set of facts in the case, the outcome could have implications beyond the fate of concentrated omega-3 products and the supplement industry. If Amarin’s position prevails, companies could decide to use the ITC as a forum to resolve competitive disputes involving FDA-regulated products or potentially pursue Lanham Act cases or similar actions against competitors even though the question at stake may have been traditionally reserved for FDA. However, the choice will depend on the relief sought, since a restriction on imports into the US would be the remedy in such cases. On the other hand, the Lanham Act could offer more broad relief in a case of unfair competition. Likewise, for companies unsatisfied with FDA’s approach to an issue—or the agency’s inaction—and the typically slow pace of litigation, the ITC provides an attractive and more efficient alternative. Regardless of the final decision in the Amarin matter, the regulatory classification of ingredients will continue to receive increased attention from FDA, retailers and other industry stakeholders. It is a worthwhile exercise for all companies to evaluate the regulatory status of their dietary ingredients. For many ingredients, the conclusion is clear. But for others, any questions surrounding those ingredients should be answered sooner rather than later."
https://www.raps.org/news-and-articles/news-articles/2018/7/update-on-the-amarin-itc-case-and-the-issues-at-st
I doubt V will make it to this year's revision. More like 2019.
HD,
I don't care if you miss on your July 30th prediction, but please be right on 36% RRR. lol
I would say rather the opposite. Met PE but failed on several key SE.
"Selling more than buying" - I suggest you check the tape. More shares were bought than sold today.
He just got spooked out of his shares and now wants to convince everyone including himself that it means something. He is just a typical retail trader who's about to miss on excellent investment opportunity because he has only one tool in his toolbox - charts.
I got it from HD. He posted a breakdown not that long ago.
IMO with low LDL and 38% of patients with Tgs under 200, I think 36% RRR in PE is probably optimistic. Although very possible in certain subgroups like diabetics. My guess is PE RRR will be in low 20s and that will be more than enough to make V a blockbuster drug.
I also agree with your point on certain subgroups that might save Amarin from a complete disaster should RI fail to meet PE.
Maybe because buying IP from Mochida now is much cheaper than after good RI results that will make everything EPA relative much more expensive.
It's amazing how one sided you became.
Sounds like a good conservative play. IMO after RI results the stock will certainly be either over $6 or close to $1
That's a stretch now.
If you know something is going to explode, you load as much as you can quietly and wait. You don't play games trying to artificially hold the price down. Because you want as little attention to your transactions as possible.
I think the reason for the current PPS and the way the stock trades is because nobody knows the results yet and there was no leak.
The reality is wether it's 16 or 36, HD makes money while Kiwi watches from the sidelines.
Not sure about Kiwi, but FFS won't care about an announcement unless he sees confirmation in charts.
How about Vegas? lol
The Value of Coronary Calcium Scoring (CAC) As The Best Assessment for Early Coronary Artery Disease – An Interview with Matthew J. Budoff, MD
"Fish consumption or fish oil (a study of a more concentrated EPA only supplement (Vascepa) – 980 mg of EPA per 1000 mg capsule. 4 grams daily of Vascepa in The REDUCE-IT (Reduction of Cardiovascular Events Outcomes) Trial he believes will show benefit)."
http://www.stayinghealthytoday.com/coronary-calcium-scoring-coronary-artery-disease-matthew-budoff/
I'm glad you were able to recover. ADCOM was a truly devastating event for many Amarin longs.
I remember a guy posting on YMB the day after ADCOM stating he lost everything and got a margin call to make things worse.
ADCOM was a terrible experience for many Amarin longs.
That's right. They saw final data back in June when selling started at $3.50 prior to last patient's visit.
He just throws everything that might even remotely support his conspiracy theory. Doesn't matter if it's true or not.
Something tells me his current leak theory is just as wrong as his numerous volcano eruptions that never materialized.
I think this will help. Makes sense to me why 2nd interim was added and why the trial wasn't stopped.
JT's remark from Q2, 2017 Transcript
"The interim look also helped confirm that our clinical sites could efficiently collect interim vital data from over 97% of the patients in the study. This results helps focus clinical site attention on getting vital status confirmation from the remaining 3% of the patients and on preparing for more rapid data collection and cleaning prior to the end of the study.
Furthermore, the waves of patient visits flowing into each interim look allowed clinical sites to meet again with patients in the study, reiterate the importance of the study and urge the patients to remain in the study until completion. We are very appreciative of the patient's continued commitment to the REDUCE-IT study. Some of these patients are approaching 6 years on study drug.
Observations from other outcome studies suggests that this added interaction between clinical sites and patients is helpful in keeping patients active in long term studies, which was always a challenge and even more so when studying conditions which are asymptomatic to the patients.
As a reminder, it was a very high bar to get over for the REDUCE-IT study to be stopped at the 80% interim look. Stopping early required achieving success against both high quantitative and high qualitative measures. We do not know if the quantitative threshold was surpassed or not.
We cannot consult with members of the REDUCE-IT data monitoring committee regarding their confidential interim data review. However, their peers within the medical community readily tell us that, because REDUCE-IT is the first study ever of this large patient population and because the results of the study had the potential to significantly influence medical care for decades to come it would have been very surprising if the DMC elected to stop the REDUCE-IT study early particularly given that the DMC had a leeway under the qualitative assessment to continue the study to completion regardless of the quantitative result.
For emphasis, I am not saying that REDUCE-IT did or did not hit the target p-value at the interim look. We won't know this until the study ends. What I am saying is that Amarin has no read-through from the interim look regarding the efficacy results in the study and we do not view the continued as planned recommendation from the data monitoring committee as increasing or decreasing the likelihood of REDUCE-IT's success at trial completion.
As we have commented in the past, it is unusual for cardiovascular outcome studies to stop early. Studies like JUPITER, which was a study of rosuvastatin also known as CRESTOR published in 2009 is still questioned and criticized today for having stopped early even though the early stop was in the wake of multiple prior studies demonstrating that statin therapy is effective in lowering cardiovascular events.
More recent, the FOURIER study, which was the first cardiovascular outcome study of a PCSK9 inhibitor has been criticized due to its average time of patient study at less than 4 years. The criticism is that more would have been answered regarding outcome as benefit of this therapy had the study gone longer, as it would've provided greater time for separation between the active and placebo arms of the study regarding cardiovascular related deaths, heart attacks and strokes."
https://www.google.com/amp/s/www.yahoo.com/amphtml/finance/news/edited-transcript-amrn-earnings-conference-221619948.html
Amarin went after optimizing market potential as they thought they were already getting 200-500 with anchor.
I have to agree 38% of patients in the trial with trigs 150-200 might skew the numbers in the wrong direction and since JZ enrolled most of them early on, I won't be surprised if placibo and control arms didn't separate until much later into the trial.
We'll find out soon. Maybe next week.
FFS, Yes some rats have been jumping off the AMRN boat. I think it's all good. Those rats will be back at much higher pps after excellent RI results. lol
Marzan,
Agreed. I also expect a fairly positive article/write up from him on AMRN in the near future.
Cantor has had $10 PT on AMRN for a while. Nobody paid attention. I doubt it will change today.
One thing for sure the stock is under tight control.
As the doc stated yesterday it's all about dosage response. That meta aka sh.ty analysis was done based on trials with 1g of fish oil that is probably 0.4g of EPA at best. That's simply not enough to move a needle.
How people can be so stupid. And they call this pile of sh.t a "comprehensive study".
New Atlas: Comprehensive study concludes omega-3 fish oil supplements don't reduce risk of heart disease.
https://newatlas.com/omega-3-fish-oil-heart-cardiovascular-health/55501/
No, I don't. But someone mentioned a transcript will be published.
Have you heard a saying "sell first ask questions later". This is pretty much what happened yesterday. We'll be back over $3 in no time.
It always takes time to digest.
85% chance of showing 15-20% RRR.
I'll take it.
They definitely picked the right Doc to interview.
The doc on AF call thinks RI will show 15-20% reduction.
Try this CC number
+1 844-776-1770 / 632#
AF's questions for the call.
Q2.
Can you handicap the outcome of the REDUCE-IT study based on prior studies of EPA and/or DHA?
Added By: adamfeuerstein
Q3.
What will you be looking for, or paying close attention to, when the REDUCE-IT results are announced
Added By: adamfeuerstein
Q4.
Assuming REDUCE-IT is positive and the benefit is clinically meaningful, how will your use of Vascepa in patients change?
Added By: adamfeuerstein
Q5.
What would you consider to be a clinically meaningful reduction in CV events?
Added By: adamfeuerstein
JL,
The only reasonable explanation I came accross was that the wash out period wasn't long enough.
Raf,
He's correct about some big fish offloading shares since we hit $3.50. But "someone knows something" is purely his imagination. He sees the charts and makes up the story to fit them.
JL,
I get your point about EPA arm. But the question is what made LDL level increase in placibo arm comparing to the baseline. Those folks were already on statin therapy. The only thing changed is they started taking 4g of mineral oil.