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The company is currently burning about $50mm in cash per quarter, between marketing/approval blunders, excess inventory buildup, erosion of US revenue, and just plain being stupid in so many ways I can't keep track of it.
By the end of this year, cash will be at a level where they'll have to make a going concern disclosure and the stock will be delisted.
Only one remedy to that and we know what it is -- a reverse and another massively dilutive raise.
What a bunch of dolts.
2g pills or combo pills or China (ROFLMAO) or court battles are not going to move the needle here.
The only things that are going to move the needle in the short term are:
- Success in the RESPECT-EPA trial, sticking its fingers in Nissen's eyes, and
- Success in other trials for other indications
In the absence of those wins, we are looking at slow, ugly bankruptcy.
You mean 2 2g pills?
It'd still be twice daily to get to 4g, but still -- just one pill each hit
Hey Hey Hey
Therapy from other sources can get pretty expensive
We've more than earned our right to non-productively bitch here!
It'll be the former -- trust me
Doing investor conferences now is a bad sign, btw.
The last thing they need to be wasting time on is repeating their lame narrative at H G Wainwright's third tier conference.
This is also an amber (if not red) flag for either/both a reverse split and a secondary offering.
Don't put it by these hacks -- this company isn't about us, from their perspective.
In the meantime, it's about the trials.
I feel much better about the prospects for RESPECT-EPA now that I have dug in more.
I feel it is very likely that RESPECT-EPA is actually an event-count-based trial, and that the trial ended when a set number of events had been observed.
And my further guess is that the trial was powered at 80% to show an RRR in line with the reblended JELIS results for secondary (21% - 22% area), at a p-value of 5%.
In other words, if the "real" benefit for the ~70% male population is 21 - 22%, then there is an 80% chance that the trial will show that level of benefit.
This can't possibly be seen as a generic-company-specific decision.
Either the healthcare providers can push generics for off label use against the brand name, or they can't.
It's a decision whether the "skinny label" means anything at all.
This is an aggressive suggestion.
People inclined to act on such a plan rarely need an outsider to provide the suggestion.
At some point no one will care what that mealy-mouthed blowhard has to say.
IF these critical trials are successful.
It’s a return to pre-9/24/2018 where the world is rolling its eyes and we’re all looking for revalidation of a substance we believe in.
Almost like waiting the Second Coming. The apostles thought it would happen within their lifetimes.
Yeah but they’re not really better than for non-smokers.
Overall it was 24% and 30% I think.
Continuing to slice and dice REDUCE-IT won’t change sales now. We need a Deus Ex Machina to change perceptions, thanks to Nissen and his gang of scumbags.
Not in the US, despite skinny labeling — courts apparently will not enforce it
Amarin did not discover or develop EPA -- they simply decided to investigate it, and they developed a manufacturing process for it.
Everything they have is based on method of use patents, which we now know are VERY weak in the US.
Regulatory exclusivity is all they have to protect the revenue stream. That ends in Europe around 2031-2. Elsewhere hard to say.
You would think that the REDUCE-IT patents (that go to 2039) would be ironclad non-obvious, but that doesn't matter any more in the US. And in Europe, will they hold up post-2032? No idea. Maybe some on this board have thoughts on that.
The markets think the well runs dry at 2032 here. So valuing AMRN is valuing cashflow for 10 years. It's hard to get big numbers if you see it that way.
From the Nissen playbook:
"Anything interesting that isn't something over which I can claim ownership requires an additional, time-consuming confirmatory trial. By the time that is over, patents will expire and/or I'll come up with something else defamatory."
Nobody makes money selling anything in China.
China is for cheap manufacturing. Western footprints in China to sell stuff to the Chinese are loss leaders. The Chinese steal everything. They'll steal this as well if they think it's worth providing.
The stakes on RESPECT-EPA just keep going up and up...
Everybody relax
Try not to see this as total failure
Fall out of love with this stock, and see this as another cheap entry point like MRM does
The shit works. Period. Bet on management being unable to totally fuck that up. $5? $8? $10? Whatever. It’s more than $1.30.
Do we know about AHA late breakers yet?
Ralphey — failing in negotiations takes up a lot of time and bandwidth for management. You have to put extra time in to ensure failure.
Failing in litigation also gobbles up a lot of management time. And bad advertising probably is harder to create than effective advertising. Missing the point takes work.
Hey Capt, further on ezetimibe -- here are the results (soft and hard MACE) from REDUCE-IT:
In both cases, there was a trend to benefit for the ezetimibe people, although more modest than the rest -- and it was non-stat-sig due partly to small sample
More important, as the letter points out, the event rate for ezetimibe placebo group is not better than the overall placebo group -- much worse for soft MACE, a little better for hard MACE. If ezetimibe was worth a damn, you simply would not have seen that.
The ezetimibe group is also hard to evaluate because (1) having an add-on medication means you're getting inadequate results from the statin, and (2) patients getting combo treatment are probably more serious about their health, and were more likely to be compliant in the trial.
Hi Chas1232123! What have you been up to these days? Are you still holding a position in this POS?
Tell me about it. It probably puts making money ahead of the user experience. Can you believe that?
I never realized until today that the JELIS result was effectively understated because of the heavily female population. The RRR isn't really 19% -- it's closer to 22%.
I like that!
Some RESPECT-EPA analysis
- It is only reasonable to conclude that the enrollment design of JELIS was unique, and that RESPECT-EPA will recruit more in line with other secondary CVD trials (~70% men).
- If I take the event rates from JELIS, and further assume men have ~50% more events than women, AND I assume that the follow-up time is longer than JELIS, resulting in 20% more events than experienced for secondary in JELIS, then
- I have a trial likely to produce about 500 events -- a reasonable round number
- Such a trial would only be 65% powered to detect a RRR of 19% (the secondary JELIS result) given a two-sided p-value of .05
To get to 80% powering, I either have to increase the number of events from 500 to ~700 OR increase the assumed RRR to ~22%.
Now, having said that, based on JELIS RRRs for men vs women (which was an overall stat, not just secondary), if I did have 70% men, the converted JELIS result would be an RRR of 21.67%. Perhaps that is how they calibrated all of this.
What does this prove? Two things -- assuming the normal male/female ratio for a CVD trial, the prospects for success in RESPECT-EPA are better, and it would be odd for a trial of this size and sophistication to be rather underpowered.
But more importantly, it proves that I have way too much free time on my hands.
JELIS question for the gurus here
This is from the trial paper:
"The participants consisted of 5859 men (aged 40–75 years) and 12 786 postmenopausal women (aged up to 75 years), with or without coronary artery disease, which was defined as previous myocardial infarction, coronary interventions, or confirmed angina pectoris."
I also found this in a design paper:
"Baseline study composition comprises 15,000 participants (4204 men and 10,796 women) in the primary prevention stratum and 3645 (1656 men and 1989 women) in the secondary stratum." [It looks like the plan was to have more women, even in the secondary cohort, yes?]
In no other CVD trial I've looked at have I seen a population this heavily female weighted (68.6%). Does anyone know why so many (postmenopausal) women were recruited in JELIS? If this really is a quirk specific to JELIS, and RESPECT-EPA is likely to have ~70% men like REDUCE-IT did, that will have an enormous impact on the expected number of events, and therefore the powering of the trial.
I'm going to do some number crunching on this now and get back to you.
Where is Extremist223?
If there were ever a time when we really needed him, it's now. Nothing makes sense.
When nothing makes sense, you need Extremist223 to supercharge it!!!
[Editor's Note: I meant Extremist223. Anyone who knows Extremist332 knows that THAT guy is the WRONG guy when things make no sense.]
ROFL
True that
The scumbags did their jobs well. Skepticism is established.
The median follow up will not be 7 years (or 8 as CaptBeer said). I don't know how long it took them to recruit the 3900+ patients -- like 2-3 years. Maybe it'll hit 5 years, we'll see.
Roughly the same size secondary population (3664) in JELIS with 4.6 years follow-up yielded only 355 events -- 19% RRR was p-value of .048.
JELIS had 31ish% men only, which seems very man light for a CVD trial, but that's what it was. (REDUCE-IT was ~71% dudes.) The men had much heavier events and the RRR for men was much higher (24% RRR, stat sig just on dudes).
Hopefully this will be a sicker and more male population.
Does that logic only apply to AMRN, or are you able to determine when any stock in general is undervalued?
Considering adding at these levels? Here's what to consider:
- Are you 100% certain mineral oil had no (or de minimis) impact on REDUCE-IT outcomes? I know we are all constantly enraged about this. But are you 100% certain? If so, what backs that up -- data, or conviction?
- Do you 100% believe in the science here? Do you think EPA has a clear and dramatic impact on systemic inflammation? If you do, then you expect it to show that in other conditions where systemic inflammation is a key element.
If you add here, right now, at these prices -- you are exposed to possible trial failures.
If MO had some real impact, then RESPECT-EPA could fail. It appears that that trial is underpowered. So 15% RRR = NOT stat sig. Period.
If the systemic inflammation theory is correct in direction and scope of impact, then the Kaiser study (MITIGATE) should be wildly successful. MITIGATE is adequately powered (80% to detect a 18% RRR at a p-value of .05). It's not overpowered like REDUCE-IT was, but 80% powering is the norm.
By the way, MITIGATE had an interim analysis: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7843090/
"A single planned interim analysis will be performed after 50% of patients have been enrolled and accrued a minimum follow-up duration of 3 months. This timeframe has specifically been chosen to coincide with the projected peak of the 2020-2021 flu season and a potential resurgence of COVID-19 cases. Given the public health implications, the co-Principal Investigators (PIs) (APA and ASG) will specifically review unblinded data comparing IPE vs. usual care for the co-primary outcomes. Based on the findings, the PIs reserve the right to publish the results of all interim analyses, but there will be no formal stopping rule in the event of suspected superiority given that this observation would be based on a smaller than planned number of events and potentially underpowered. Thus, the MITIGATE study will complete recruitment as planned, acknowledging that interim findings may influence the subsequent management of patients pre-randomized to the usual care arm (ie, passive control). Given the pragmatic nature of this research, there will be no adjustment of the overall a for interim analyses. In addition, there is also a strong probability that the co-primary endpoints are highly positively correlated, greatly diminishing the risk of multiple testing leading to an inflated type I error rate (ie, false positives) and therefore adjustments for multiplicity with respect to the co-primary outcomes will also not be performed."
It appears clear they would not stop for efficacy -- not clear whether they would have stopped if there had been a futility signal, but I lean toward believing they did not get a futility signal. Politics of continuing in the COVID hysterical environment would have been rough in that case.
If you are a country drug regulator, and you're looking for excuses to fade Vazkepa, the Nissen peanut gallery has provided that.
Drug companies don't care about patients. Regulators don't care about patients. This is about money, and trying to avoid paying it.
MO gives them a leg to stand on. So they'll stand on it until further evidence kicks that leg out from under them.
Is he just an incurable statinista? Is that all this is?
I'm trying to figure out his motivation -- I've always assumed it's financial.
But maybe he is just nuts.
RESPECT-EPA
Trial is supposedly complete Sept 15
Will anything be released prior to whatever conference that was where they would be a "late breaker"? (Like AMRN did with REDUCE-IT -- top line early, the rest at AHA)
Can they even patent the combo pill? And how would that withstand an attack based on obviousness?