Not sure if this has been posted already, but a ridiculous increase in SI since last settlement date of 8/15. About 3.3M share increase.

https://www.nasdaq.com/symbol/amrn/short-interest

Good morning. I still have not heard a logical reason why these final results have taken 38 days, and counting, longer than 2A. Talking about basically the same amount of data, maybe a few more events. But 2A required a DMC meeting which added logistical timing. Plus final results will be the THIRD time going through this process, so there should have been added efficiencies and lessons learned through the first 2. I understand these are the FINAL results but technically both 1A and 2A could have been FINAL. Shouldn't all the cleaning and data preps been the same each time in case of stoppage? Don't know, just getting tired of waiting on this company which is basically all we have done the past 7-8 years (approval, NCE, script growth, SPA Appeal, 1A, 2A, Final, etc).

In case you are keeping track, between 1A, 2A, Final, we have waited a total of 515 days. That takes a whole lot of patience and fortitude. Let's just hope it's worth it!

Have a great day!

Benny

Raf,

I received the EXACT same response from IR on Tuesday morning so she is just cutting and pasting at this point.

Benny

Raf,

From my experience with IR, if it hasn’t been publicly stated, she will not be able to say. So if you ask if Database locked she would probably say, “As per last CC we are aiming for database lock by end of August.”

Benny

VuBru,

Not sure they are going to bother to change verbiage at this point. Don’t think they will say Top-Line results in next couple of days. Technically this was as of Sept 1st so probably still didn’t have things completed. Tomorrow, or next week still possible IMO. This will make every wake up exciting for next few weeks!

JL,

The only I can add to your post is the fact that on Tuesday IR did confirm to me that they were aiming to LOCK database by end of August. Originally I felt there was gray area with “key steps leading to database lock”. But Elisabeth said database lock. Again we don’t know if this actually happened or not or when it happened. But if they were running behind on steps for this lock I would think JT wouldn’t have said end of August on Monday.

Zip,

That is my point. Database could have already been locked but when JT is correct in stating company still blinded to results as of 8am Monday morning.

This has been an observation seen over the last few months, not just recently. I am not insinuating that Elisabeth has ANY knowledge of results, but just making a comment on their level of confidence.

Kiwi,

No, I am certain that as of 8am Monday morning the company was still blinded to results. That doesn’t mean Database was not already locked. Not sure the lag in communication between CRO and JT. Maybe as of last time he spoke to them it wasn’t, but was VERY close. The fact he had to “reference” the last CC and not just come out and say it wasn’t locked makes me believe he wasn’t certain.

Not sure how many on this board have had opportunity to share conversations with Elisabeth in IR. Understandably, there is only certain amount of information she can share. But what I have noticed, especially recently, is how excited the company seems to be about the upcoming results. This seems genuine and comes out in the verbiage she uses in her emails. It has increased my already high level of confidence in results.

Btw, IMO, Database is locked. What is the likelihood on August 1st that they predict before or near end of August and it got locked exactly on August 31st? I think it may have been locked during CC, but they were not sure. JT even said “I reference the last CC when we stated key steps leading to database lock by end of August”. Why would he need to reference last CC unless he didn’t actually know for sure? Sorry, rambling...Have a great night and reach to your friendly IR if you get a chance!

****From IR*****

This should clear things up:

Hi Ben- Thank you for the nice comments.

As of the conference call yesterday, we are aiming to lock the database by the end of August. After the database is locked, there is analysis that needs to be done, and we guided that we will report the REDUCE-IT top-line results before the end of September.

Zip,

I hope you are right. I just emailed IR to see if they will provide clarification, but I am sure she will just repeat what JT said.

Raf,

Listened to the call last night and also looking at your IR response. It’s funny the way they worded it. By end of August, complete key steps “leading” to database lock. At least from what I heard, JT never actually came out and said database would be locked by end of August. Maybe this can be inferred by this statement but it does leave some grey area. Even the “key steps”, are there other steps before database lock. Just bored so thought I would spend time reading into this probably more than I should.

Possible, but unfortunately Raf, I think you are looking at a sleepless 3 day weekend!

Raf,

I am waiting for transcripts to come out to see exactly what JT said. But remember he is in communication with CRO but it might not be daily. Maybe as of Friday it was not locked but potentially by Monday morning it was. Regardless many people said he did say “end of August” which is good enough for me.

Dew,

I couldn’t agree more. The only way to “Defend ASCEND” is to actually have Positive R-IT results in hand. Otherwise the market doesn’t give a shit how the trials differ in dose, design, etc. Its all about results and V is unfortunately still fish oil in eyes of many until these results are done.

If Q&A on CC, some ask JT what the f$&k is taking this final process so long. 3rd time doing this, should have this down to a science!

Busted:


G.

Great post..Have not worked it out myself, but every line of your post makes sense...

Thanks for putting this together...Looks line the end of JULY

Regards..":>) JL

Top-Line results may or may not come on Monday. But as far as R-IT, at minimum, I would like to know exactly how close they are to being done. Not this “by the end of Sept” crap. I want to hear something like, 100% Vitals completed, 100% events adjudicated, and only very few queries remaining. Database should be locked within week and results shortly there after. At this point, I think it’s pretty ridiculous if they cannot marrow this down to less than a 5 week window. If there are still truly that many weeks left of this process, then they are seriously dragging their feet. But in either case, they should have this timetable pretty precise by now.

From last CC:

“In addition to now being an exciting busy time at Amarin, it's also a busy time for other omega-3 clinical trials. After decades of no large outcome study being conducted of the earlier generation omega-3 mixture of ethyl esters, Lovaza, as an add-on to statin therapy, 2 outcome studies of low-dose Lovaza will soon be reporting results. I'm referring to the ASCEND and VITAL studies. These 2 studies, the first of Lovaza plus aspirin, and the other of Lovaza plus vitamin D, are anticipated to have results reported this year, with the ASCEND study scheduled to report results later this month, August. I mention these studies here because if the studies do not succeed, which is quite possible based upon the drug and dose they're using, some people may interpret this as negative with regard to the potential results of the REDUCE-IT study. It would be good for society if the ASCEND and VITAL studies succeed. If they do succeed, it will further increase our optimism for the REDUCE-IT results from the perspective that if 1 gram per day of an omega-3 mixture provides benefit, then imagine what might be achieved with 4 grams per day of pure Vascepa. But if ASCEND and/or VITAL do not succeed, I urge investors not to be surprised or to read into this data any conclusion regarding the REDUCE-IT study. We expect the ASCEND and VITAL studies to not meet their prespecified primary endpoints. Failed results in those studies are consistent with Amarin's thesis of needing the right drug at the right dose, studied in the right patient population to succeed. If these third-party-sponsored studies do not succeed, we will look at such failed results in those studies as further clearing the path for Vascepa to become a well-differentiated standard of care following REDUCE-IT results. Assuming the unique effects of Vascepa lead to REDUCE-IT's success, Vascepa will have positive outcome studies results, while earlier generation therapies, including Lovaza, fenofibrates and niacin, will all have had negative outcome studies. The same logics, which is supported by various scientific data, applies to interpretation of recent meta-analysis, which suggest that omega-3 mixtures such as Lovaza, are not effective in lowering the rate of cardiovascular events. Again, some investors might interpret this meta-analysis as negative for Vascepa. In fact, some investors have told me that they interpret such analysis as lowering the likelihood of REDUCE-IT success. Inversely, Amarin sees this meta-analysis as opportunity for Vascepa. For years, we have stated that we believe that to be effective in treating cardiovascular risk beyond cholesterol management, you need the right drug, administered at a meaningful dose in an at-risk patient population, and studied rigorously over an adequate period of time. Witnessing less pure omega-3 mixtures fail when administered at 1 to 2 grams per day, is not a surprise to us, and in our view, not new. Such meta-analysis has existed for years.”


That is a lot of JT’s time and energy spent already discussing his thoughts on ASCEND. Why waste any more breathe?

But why? Who gives a shit about stock price if R-IT is positive? Why have a CC to minimize damage when results coming in 4-5 weeks at latest. Just spend time and energy getting these results out and not worry about anything else.

He also starts remarks:

“Good morning. Today is likely the last time that Amarin will share prepared remarks with you prior to our communicating to you the results of the REDUCE-IT cardiovascular outcome study.”

Which is “by the end of Sept”. He has been saying “end of Sept” for months, why would he change that now? I am not saying results will be announced, just saying it’s within the timeline, just a month early.

I am baffled we don’t already have results based on efficiency of completing majority of site visits by Apr/May. Also the fact that this is THIRD time going through this process.

Monday is “by the end of September”??

So what changed since yesterday? They could have easily put this PR out Friday morning or AH Friday. Why wait until Saturday morning when market closed?

They had previously stated they would have a CC to discuss Top-Line Results. Would they really have a CC about RWE and then have another one a few weeks later to discuss R-IT results. Doesn’t make sense. They could have just put out the PR and discussed at another time. But who know???

Kiwi,

"Uber Bulls".....You are damn right about that. You look at the # of posts by the likes of BB, JL, Raf. They have contributed thousands of posts to this board. So they damn well better be Uber bulls or what in the hell is the point of them wasting all that time posting?

Oh wait, you have over 7,700 posts, what's your excuse:)

Benny

Sts-

Sorry you are missing the point. Fructose is the culprit in this situation and sucrose is made of 50% glucose, 50% fructose bonded together. This bond is cleaved as soon as digested. So both HFCS and Sucrose are equally as bad!

Incorrect, please read the last line of this study:

https://www.ncbi.nlm.nih.gov/m/pubmed/20086073/

JL,

Unfortunately problem is not just with the “fat people”. I have watched many lectures by Dr Robert Lustig. He had a Venn diagram in one of these lectures that told the story. It was broken down by normal weight and obese people and percent that had metabolic dysfunction. Out of 240 million Americans, 30% obese, 70% normal weight. 80% of the obese population had metabolic dysfunction equating to 57M. However 40% of normal weight had metabolic dysfunction which equated to 67M. So there are more sick normal weight people than obese. And over half of US population is sick. That’s scary.

One of main issues is people have no idea how to eat anymore. We have been told fat is bad and we should all “eat less, exercise more”. And a “calorie is a calorie”. All this advice has been shown to be completely wrong and not work. The food industry has removed all the fat from foods and replaced with sugar. 80% of all food in a supermarket has added sugar. And the myth of high fructose corn syrup being worse than sucrose (table sugar). It’s all added up to an extremely sick population and yes, a very obese population.

85% confidence in success of trial is not conclusive but pretty eff’in convincing!!

Raf,

I started with intermittent fasting a while ago. Recently I have been extending my fasts. My longest has been almost 4 days where I dropped 9lbs and have kept all of that off and more. Currently down a total of 23lbs.

I like to begin each week with 24-48 hour fast to get body in ketosis. I eat ketogenic diet the remainder of week. On weekends I don’t go crazy but at same time I don’t restrict. Hence the reason for the fast to start the week.

As a society we have been taught to eat 5-6 small meals a day which has basically kept us in a high insulin state. And we wonder why insulin resistance and Type 2 diabetes is such a growing epidemic. We have gotten it wrong for 30-40 years with the idea that fat was bad and better to replace high fat with high sugar.

Marzan,

There is no DMC for final. Results are reviewed by company and advisors so once database locked, should be only few days to announcement.

Benny

Agreed! And hopefully sooner than later because sick of waiting for redemption for all the sh$t AMRN shareholders have had to endure since ADCOM!

I was not disregarding importance of SE’s. But from an ethical standpoint, to continue a trial showing 30% + RRR is wrong, IMO!

Barring a tremendous separation in the final 386 events, RRR at 2A and final are not going to change that significantly. JL just pointed out that could be blockbuster and still continue. The problem is we just don’t know where that line is drawn. (20/25/30/40%). So again, all left to ponder and wait for that PR in the coming weeks!

JL,

Your guess for RRR at final was 33% and HD 36%. I have upmost respect for both of your opinions. But to realistically hit either of these marks, RRR at 2A would need to be upper 20’s to near 30%, or higher. I completely understand what you are saying about SE’s. But I have a hard time seeing DMC staring at an RRR of around 30% PE and not pulling the plug. Thanks as always for all your posts!

Benny

MrMain,

Let’s look at some math and see where we land. In order for 1612 events to show 30% RRR, you need approx 950(P)/662(A).

2A has 76% of total events ~1226. What if at this point RRR was 25%, would this been enough to warrant a stop? If it had been 25% at this point, the remaining 386 events would have needed a RRR of 45% or 249/137 in order to achieve this 30%.

So I guess what I am saying is it’s possible to still hit 30%+ if around 25% at 2A was not enough to warrant a stop.

If lower than 25% at 2A, it will take some serious separation over last 386 events to get above 30%.

Not sure if this helped at all??

BioChica-

Missed an important quote in that CC:

"Most clinical sites have responded fully to resolve data queries. For those clinical sites with data queries remaining, we look forward to responses soon."

So it looks like there is probably not that many queries remaining, just a few outliers? He also says "before or near" end of August, which makes it a pretty vague statement. "Before"---Monday???

Remember during CC before 1A, JT mentioned they had 3000 data queries and in a couple weeks got them down to 1000. I cannot imagine there were more than a 1000 queries remaining as of August 1st. Especially if he is saying "Most clinical sites have responded fully" So again, I would be shocked if this goes until the end of August.


Have a great day!
Benny

ggwpq,


"due to 175 additional patients and 3-month delay in last event"


During the Sept 12th, 2016 PR to announce trial will proceed as planned after DMC review. This is a quote from PR:

We continue to expect the onset of the final primary cardiovascular event to occur in the second half of 2017 with the publication of results anticipated in 2018."

The PR for 100% onset of final event didn't occur until April 2018. So even if "2nd half" meant the very end of 2017, they were still at least 4 months off projections. But I would infer "2nd half" to mean around Sept/Oct, so really 6-7 months off of projections. And that PR was less than 2 years ago.

Have a great day!

Benny

Marzan,

Appreciate the shout-out, but I am no where in the same league as HD in keeping records and details about trial and company. I am just surprised based on everything we have heard that results have not been released. This is their 3rd time doing this process. These clinical sites should know the deal. Answer their calls, fix the data inaccuracies and get this thing over already!