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The last few days I've seen the exact same transaction being reported after hours: 19,900 shares being purchased at a price that does not match the day-end PPS.
This has happened for at least the last three days in a row. Does this seem strange to anyone else?
Ralphey may be right on a few things, if he is a dr. and is seeing people's TG data. He can't be sure if there are no CVD benefits to the drug, but he might be convinced based on a relatively small sample that it doesn't do a great job lowering TG levels.
If that's the case, I think others here who take V and are seeing big reductions should speak up right away!
For my case, I have been taking V for a good while now, and my TGs have only gone down a small bit. LDL also went down a small bit. Numbers haven't budged much, and over time I went from 2 MG to 4 MG a day. Does that mean it isn't an effective drug? Can't tell by my numbers alone.
As much as I hope and dream that the R-IT trial shows amazing results in some populations, I am getting seriously stressed out. There's enough doubt gathering about the potential of this drug to make me seriously consider reducing my position before final results are known.
That said, I expect to be holding everything into 2018. In the latest conference call, I feel we were being told that Amarin's news stream should be picking up - including information not directly related to R-IT study. If they don't issue some promising news in terms of their overall business development by mid Q4, my discomfort is bound to grow.
Raf - good comment. I am beginning to believe that AMRN set the bar for stoppage at an uncommonly high level. The only reason they get a stop is if PE and SE are so superior that the 80% data is unassailable.
There was evidence that the 80% event took a bit longer than expected, so that's a nice plus. But I am now 10/90 on a stop.
I'm preparing myself mentally for a significant price dip when they choose to continue. I can't make an argument for buying more at a lower price. I've done that as much as I can.
Where'd everybody go?
A day without lots of AMRN posts is like a day without sunshine. I suspect a glitch...
Lack of Insider buying is probably due to too many material activities underway during this period. First and foremost in my mind is any licensing / partnership deals that are being negotiated. They could be negotiating expanded approvals with FDA via 1A win. Hard to make insider buys when you're in the middle of important negotiations.
Or they could be simply awaiting DMC recommendation.
They have to be very careful not to get sidelined by legal matters right now, since so many things are in play. So it doesn't make sense to be buying shares simply to send messages to investors. They already have plenty of shares, anyway.
Does anyone here expect early announcement of halt/continuation?
It seems to me there are far fewer events to adjudicate and less data to perfect from 60 - 80% than the first 60%. Also I would expect methods of cleaning up the data and confirming results to have gotten somewhat easier, at least as far as it concerns collecting data from practitioners participating in the study.
I know the company likes to maintain conservative estimates for all communication purposes, and I tend to believe them. To me, they've sounded more-than-usually vague on the expected time frame for a recommendation.
Am I being too hopeful here?
Raf - agreement here, too. I believe last time we were waiting for interim results we experienced an uptick in minor bickering over an assortment of issues. It's an anxious time, waiting for results. I've tried to stay out of the fray, but I watch every day!
I did. Several times over the past month or so. BTW, I notice Thrive algal oil now retailing at a Mollie Stone's store in San Francisco. So perhaps the distribution is spreading out a bit more.
If this is a mini-bear raid, it seems appropriate that it happens shortly before this particular earnings report. If the 3Q report reveals that the company is now generating positive earnings, I would assume the ability to create these mini panics diminishes.
Guess the V Day Contest #2
heysfguy
April 22 / July 22 / stop / 22%
JL, I'm having trouble thinking AMRN can direct RI study personnel to include extra events as they occur after interim look is triggered.
Once they believe 60% of events have occurred, they probably can only direct those in charge of the study to begin the process of locking down data for analysis. If patient X123's data has been locked as of a certain date - say July 1 - and they have an event on July 15, it's too late for the event to be included in the data set. If they allowed it to be included, then wouldn't they have to go back to all the other participants and get their data extended to July 15? That doesn't sound viable to me.
This further leads me to believe this is why they initially set the the trigger at 60%, not at a true numerical half-way point of 50%. (No need to artificially string the study along, waiting for extra events.)
Which also leads me to believe that unless they hit analysis or data procurement snags, we'll hear something by the third week of September, if not sooner.
JMO of course - I am just an investor, not an expert in any way. Just trying to use deductive reasoning.
Beautifully put, T. Management certainly has been performing at an extremely professional level, tamping down unreasonable expectations, taking care of the bottom line, and picking the right path to success with the FDA.
Chas - I like your thinking and analysis - being a long, of course, I would!
In response to your thoughts about trajectory of PPS over the coming weeks and possibly months, I don't expect any really big jumps. But I do expect steady price appreciation, decrease in shorts, growing institutional accumulation.
I expect PPS will raise incrementally through much of September in expectation of DMC recommendations. In the meantime, the PPS could additionally benefit from additional bullish indicators, emanating from various sources: FDA, AMRN or even other published research (continued thanks to Zum on that topic).
But I don't expect any big gaps to appear until DMC recommendations are communicated. Barring any global headwinds, or an early announcement, I think the PPS will be about $3.40 by end of month, climbing at a slightly steeper trajectory each week into September until we get an announcement.
FWIW, a co-worker showed up today with a really nasty burn - about 6 square inches of badly damaged skin around her shoulder and armpit area. She said she had been distracted while handling a hot rice cooker. She added that the wound was healing really fast, thanks to a cream her family uses from Iran. (Not available in the States.) It has some zinc oxide in it, but the major ingredient is...fish oil. Not only helps with the healing, but apparently completely soothed the pain from the inflammation within an hour of the accident. She swears by it, and offered to get me some. I said, no thanks, I've got a little "fish oil pill" (V) I can just break open and apply directly.
Here's a theory for you: Secondary endpoints have multiple strategic goals, such as
1) If primary endpoints are met, then secondary endpoints may lend weight to pinpointing mechanism/MOA that are the foundation(s) of primary endpoint success. For instance, RRR of xx% appears due largely to these factors: (such as EPA/AA ratio, other biomarkers, etc.) This gives AMRN extra leverage with FDA if they accept DMC's recommendation to stop the study.
2) If primary endpoints are not met, then secondary endpoints may indicate success in certain subgroups, which may or may not validate partial stoppage for a group; or may provide AMRN with extra study time for RRR success to meet stoppage goals (as pointed out by others).
There are likely other strategic advantages to the creation of secondary endpoints, but I doubt AMRN would have agreed to these additional factors if they did not feel confident that they stood a good chance of meeting secondary endpoints. Nobody's going to put together a $xxxMillion dollar study and create secondary endpoints that are likely to fail.
I won't opine on the strategy behind 2nd interim look, as that is a separate topic.
It's clear the share price isn't coming down appreciably any time soon. So those of you who are still hoping to get in at a substantially lower price, forget about it. You can stop hoping for a decent buying opportunity for your friends. If they didn't get on the train at the $3 station, too bad. We're not going back to pick them up. There's just too many potential positives on the horizon. Their best remaining buying opportunity is now.
This article was also shared by dmlcento recently. I felt the "conclusion" looked promising.
Thanks, HD. This is excellent analysis, thanks so much for your contributions. Leaks or not, the accounting evidence supports the current PPS, in terms of expectations going forward. Improvements in sales and sales margins are highly attractive.
Hopeful Thoughts for the 4th of July weekend:
Here are good reasons to believe AMRN is making significant headway on several fronts and will continue to pull it together as a successful entity (and feel free to add your own points)...
Improved sales and market share with no pullbacks over a significant time period
Continued hiring at upper management levels (a clear sign of confidence)
No insider purchases in a long time (imminent activities)
Significant stakes purchased by other experts (Baker Brothers)
1st A settlement includes provisions for adding revenue streams from non-CVD populations (diabetics, dry eyes, brain injuries, depression)
NCE victory (extra IP protection)
and perhaps most importantly,
double blinded trial tracking to expectations from previous studies.
From all this, I'm willing to believe that there are so many potential upside catalysts that I have added significantly to my position over the last 12 months.
I would not be surprised by early trial stoppage for effectiveness. I would not be surprised by partial stoppage in the subgroup of the trial. I would not be surprised by a new partnering agreement, or positive news on the Chinese market.
In fact, nearly all my expectations are positive at this point.
The negative potential of this company's operations diminishes with each passing week, and it would take a hugely unanticipated event to throw a monkey wrench into the machine that AMRN has built over the past couple of years, post ADCOM.
Happy Independence Day to all!
Thanks, Wodehouse. Glad I'm not the only one with the view that the placebo prognostication thread should be retired, or at least put on pause for a few days.
Actually, there seemed to be a nice period of silence on the topic for a while after my initial post. Just my opinion as a long term investor, sorry to see it got under someone's skin so easily.
RAF I was merely pointing out (in complement to your post) how useless these placebo-related posts are. You obviously couldn't - or didn't care to - figure that out. I'm actually hoping it was the former.
Add that it's only American data, again, removing it even further from relevance to AMRN's trial. Another reason these placebo-related threads need to go away for a while.
What's this you say about "relevant data," RAF?
All the sophistication on this board regarding this so-called "relevant data" (placebo rates, prior studies, enrollments, etc.) amounts to reading tea leaves at this point. Anyone thinking otherwise is fooling themselves.
At this point I'll take a short thread over endless techno-drivel one- upmanship any day.
Can we please discuss something other than placebo rates?
Nobody knows the placebo rate, including the very people conducting the study. Nobody - certainly nobody on this board - has the analytical tools, detective skills and/or magical powers to pre-determine the rate within any degree of meaningfulness. So please let's move on for now.
Unless HD wants to do a contest on mid-study placebo rates, in which case I'm at 5.73262%.
Wow. Nice catch, HD. Where could that additional $1M have originated? Any other ideas/concepts, anyone?
BC - fascinating study, thanks for posting. I especially like the opening sentence, where they state we take it on faith that saturated fats raise LDL cholesterol, etc., based on a European study done long ago.
ZU - you're on quite a streak!
Thanks for the recent study posts, very exciting. (And the other commentary is appreciated, as well.)
Kiwi, if you can do the Dipsea thing, you can do LV in the summer.
We hike Dipsea / Steep Ravine frequently, so I know what I'm talking about. In fact, I've probably seen you go huffing by, all sweaty and proud.
Thanks, HDG...so we're still limited to Conference Call Q and A responses, with regard to potential China sales.
Thero's response appears to keep in line with Amarin management's "do not raise expectations" approach. However, his wording clearly indicates that management expects to announce some sort of modest milestone progress in 2016/2017. Depending somewhat on the timing of an announcement, it might even have a strong impact on balance sheet projections.
At the very least I expect Thero to field this topic again at the next CC in a month or so. Getting ready to read the Chinese tea leaves!
Does anyone have the latest on potential sales timetable for China? Seems to me that even if China limited Vascepa sales to the hypertrig group, we'd have little or no problem with substantial improvements to the balance sheet.
Zumantu, more evidence that they want to downplay the latest info on the interim event: the title of the press release is about reaching target enrollment.
Then they slipped in the information about the pending interim results. I guess they really don't want to get people like us to get overly excited.
I'm sure they're preparing for the next CC very, very carefully. I also assume they're extremely active on potential teaming/partnership conversations.
Pressure building for additional partnerships?
With all the increasing interest in Vascepa/EPA for currently off-label conditions (most recently evidenced by the study for Alzheimer's), it seems likely that interest by major pharma companies is increasing every month.
Evidence to suggest AMRN's interest in additional partnerships - even for off-label uses include:
Changes in AMARIN's website language
Recent high-level hiring
1A settlement language allowing an opening for additional off-label promotion
I think there's plenty of evidence to suggest that AMRN is contemplating additional partnerships - since buyout offers would be entirely premature at this point.
Looking forward to some increase in prescriptions, as well. I finally got a prescription two months ago, and will have blood work re-done in another month. Looking forward to sharing good results.
Hang in there, and enjoy the Easter weekend!
Zu - interesting article. Did you notice this quote?
They cited trials such as ACCORD, AIM-HIGH and HPS-2 that not only suggested there was no benefit to additional lipid-altering drugs, but also that there could be risks to combining drugs as well. Current guidelines for cholesterol management do not recommend “adding triglyceride-lowering medication to statin therapy in patients with elevated triglycerides,” they wrote.
How strange.
I'd rather have slightly disappointing but hopeful news than plain old bad news. There is a path going forward, and it is looking positive, on the whole.
AMRN and their attorneys punched a small hole in the FDA wall of tyranny, but were probably cautious about being the only company to be able to take advantage of that hole. You don't want everyone else using your settlement to their advantage. So they kept it localized, and it's probably not a bad idea.
Just slightly disappointing. I think there are some big developments directly ahead of this, and it's nice to have the 1A overhang gone.
I posted a long-winded status piece, only to find that in the intervening time, a "settlement" had been reached.
That may be so, but it is up to the court to approve the settlement.
Given that the settlement involves on-going adjudication by the Court for future disagreements by Amarin and FDA, I think the Court may reject the settlement. It's like saying, if we have any disagreements about the settlement, we'll ask you to get involved again.
No dice, I think.
If anything, the settlement confirms my belief that Amarin couldn't get FDA to provide enough assurances of off-label promotion for a wider range of uses, so it punted -- it came up with this highly doubtable "settlement" and is hoping the judge rejects the whole deal and makes a Permanent Injunction.
Any chance the 1A negotiations will allow AMRN to promote for other, non-CVD indications? We've been soaking up the news about EPA's potential benefits for diabetes, depression, dry eye syndrome (just to mention the D's). If the 1A settlement is about "truthful and non-misleading" speech/advertising, couldn't it possibly be put in service of other off-label uses? I'm wondering how others on this board feel about that aspect of the negotiations currently underway. I expect certain people who know FDA, Pharma and medical practices much better than I may be skeptics, but I'm wondering why Amarin wouldn't be pursuing language that would allow them more leeway in these areas, as well.
Kiwi: HD will have problems translating "baited breath" as you say. The phrase is "bated breath" meaning breath suspended (abated). "Baited breath" is when you eat too much raw fish trying to get your Omega nutrients. Not sure which is your particular condition. :)
Every time we get close to a meaningful event in the AMRN history book, it seems the level of friction on this board goes up. Now with Feb. 17th around the corner, as well as some sort of heightened awareness of an R-IT "interim event" on the horizon, the heat is rising again. People are starting to get a bit personal with their posts, which is sad.
I can think of no rational basis for the aggrieved posts of Mogwai, and the nit-picking, fault-finding attempts of Kiwi -- at least not if they are longs. So I ask myself, where does their motivation come from?
Since I'm not a psychologist, I am unaware of any disorders that might cause this behavior. (I have a friend who has a contrarian-like disorder, but it is mild.) Lacking a psychological explanation, that leaves only ulterior motives as the basis for their consistently negative posts.
Not that I don't always disagree with their viewpoints, but...something still isn't making sense in the bigger picture.
Mogwai, you're making sense to me. There are no damages being discussed in the 1A suit - it was a pre-emptive act, so no damages are due to the plaintiff. I believe the only discussions they could be having are about advertising and promotional speech.
The only other 1A option is to make a labeling deal in exchange for dropping the suit entirely. If the FDA is concerned about making a deal with AMRN that sets a precedent, then this may be their best option, especially since they rescinded the SPA.
In the NCE suit there are no settlement discussions, period. It has been remanded to FDA for internal reassessment.
Talk of damages by anyone on this board is, as you say, totally delusional. AMRN is not interested in damages, AMRN is interested in sales and balance sheet issues, ultimately determining an appropriate buyout valuation for the company.
I am getting very frustrated with the cone of silence that has descended over these legal issues. I realize we're not entitled to an explanation of what's going on. If we were, don't you think the institutions with vastly larger holdings would be making demands?
Let the big holders do the work here, folks, and trust that management, after some substantial wins, is finally turning this team around.
That said, JT didn't help us with his Anchor response, and he may be regretting that one. However, it does seem completely unlikely that anchor indication is part of the negotiations. I agree with others who feel it's strictly about what communication is permissible and what is not.
If the FDA is supposedly trying to force AMRN to disclose failures by Niacin, fibrates, etc., I say hoo-ey -- a judge would toss that immediately. Their attorneys must realize this.
JT said their efforts were to "completely" resolve issues. That means leaving nothing open to FDA interpretative games. It's probably easier to wrestle a greased pig. And maybe more dignified, too.
Now that I think of it, I think the eventual resolution of this matter will be a letter that says "THIS is what we agreed to, and THIS is what we couldn't agree on," and then toss it back to the judge for an ultimate decision.