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ZZ - Thanks. I think we have to remember that V works via multiple mechanisms, so results for death reduction in prior non-EPA trials are of questionable utility in predicting what the SEs will show. JELIS showed directionally lower death (and similar RRR to the primary outcome IIRC) but was not significant due to the small sample size. Given the high risk and large sample, I think R-It will have a sufficient sample size of deaths to be nominally significant (p<.05) if the RRR is in the same range as the primary MACE outcome. That plus JT's statements regarding robustness "across multiple SEs" make me certain that hard MACE will be significant (SE #1), and so will CV death+nonfatal MI composite (#2), and fatal/nonfatal MI (#3). CV death is the 4th SE tested, and my guess is that this will likely be significant too (because it is also captured in SE #2). Only reason that it might not be is that if the coronary revascularization SE is not significant, they would not be able to test CV death. Based on some things I have seen in other articles, this is a possibility.
JL - In the transcript of the Cantor presentation last week, JT said they had internally predicted 22.5% RRR before they knew the results.
Thanks Gabor.
If you are willing to hold for a while, buy BEFORE Nov 10. It is very likely to go up substantially after that. My opinion would be to buy sooner rather than later.
Good points - I keep forgetting about all the PCPs out there who would prescribe V. If it shows particular efficacy in T2DM, I expect that may broaden prescribing by other specialties as well.
JT - All good points. Good find re: old secondary announcement. JT also recently implied that they would not necessarily need more money because of the end of R-t expenses (and presumably increased sales fairly quickly).
Thanks. Looking forward to reading the details.
HDG -
You are "right" … and your post is a perfect proof why I am right … I doubt you will understand it ever.
Rose - Because JELIS showed the biggest effect on angina, many are mistakenly assuming hard MACE will be poor for R-It. That is clear from quotes from multiple MDs across several articles. This ignores the fact that RRR in JELIS for those at high CV risk was even larger for CV death and MI than for angina - the issue was they didn't have enough events to show significance. Given everything said by the company and their excitement about the robustness of the results, looks like hard MACE and at least a few other SEs are going to be significant - otherwise, why would they keep saying "watch the AHA presentation to see what we have" They would not work to call attention to negative results. I take the Cantor note to be saying "if hard MACE and other SEs are significant, then it will be more of a bull case scenario."
Bfost - That $60 bull case PT is the highest "official" one I have seen yet. Given what the company has hinted at repeatedly, I think the bull case is likely.
The fact that hard MACE is another composite is a good thing - it increases the number of total events and makes statistical significance a certainty (I think only p<.05 is required for an SE) if it roughly matches the overall RRR. The JELIS results suggests it should be at least 25% RRR or even a bit higher.
Thanks for the post. I think Khaneman won the Nobel prize in economics, despite being a psychologist. His theory was not intuitively obvious and had a big impact on the field of behavioral economics.
JL - I think you are right on. That fits with JELIS pattern pretty well.
Raf -
I think it will jump around some with a generally upward trend until Nov 9, with the price around $25 at that time. On the afternoon of Nov. 10, I expect outstanding results to be announced, with a rise to low-mid $30's over the next few days. Once the article comes out (by end of year), I think it will go up more. My guess is near $40 by end of year. To go out on a limb, I think they start seeing BO offers before March, at minimum of $45-50/sh. No idea if they would take that.
If AHA results are not great (unlikely), I see price staying in mid-20's short term, increasing to 30s over next 6 months.
Kiwi - I came across AMRN by accident. I had no intention of investing in individual stocks, but had some money sitting around earning nothing. I accidentally clicked on a link, which took me to a Motley Fool article on a potentially undervalued stock with risk but very high potential upside. It was about $2.50/sh at that point, but by the time I learned more about it (found iHub board, articles) it had increased to $3. I ended up with 27,000 shares at $3, although it was not always easy convincing my wife to take a chance on this. She now thinks I am a financial genius
Because they were prohibited from reporting secondary end-point results in their PR due to AHA embargo rules. They did talk about multiple SEs being robustly supportive of primary results (they could not use the word "significant"). The first SE tested in their sequential analysis is "hard MACE" (MI, death, stroke) which is more important than what they previously reported, and many peoplle assume they will fail on this endpoint. However, they are not allowed to test the next sequential SE unless the first SE (hard MACE) is significant, ergo, multiple SEs robustly supportive means at least that first two were significant. Their results will be stronger than anticipated and the price will go up.
AVI - Thanks. Key differences between this study and the DCVAX study are that this Phase II trial only followed patients for a maximum of 5 years, and there was no crossover. This seems to limit their ability to capture "long tail" survivors, who would make the OS number better. I fully expect DCVAX to fail on PFS. I think the long delay in unblinding the DCVAX trial is because of exactly these issues - extending OS to the max is their one chance at success.
I invested in AMRN because I believed in the science (scientist by training), even when naysayers talked down the price up until the day their amazing results were released. It was way undervalued until it succeeded. I invested in NWBO 1 1/2 years ago (at $0.20) and have continued to accumulate (even sold some AMRN to buy more) - I do this because I believe in the DCVAX science. This is not a scam, and the stock is way undervalued. They have top notch researchers who invented it and are convinced it works, and a peer-reviewed blinded publication giving strong clues about what the results will be. In a worst case scenario, I cannot see this failing to be approved eventually just on extended OS in a subgroup, given the new FDA attitude. Maybe DCVAX Direct will succeed long-term as well, even if DCVAX L fails totally for some reason, or maybe they both succeed. I have 150,000 shares now, and will keep adding more after the AMRN price goes up more following the AHA conference in November. I also feel like my NWBO shares are almost "free shares", with a good chance of a price increase of 10X+ within the next year. If not, lesson learned, but I still feel like it was a good bet. I am hoping lightning strikes twice (AMRN and NWBO).
If we can get the price up to $40 or so, we plan to pay for our kids' educations, take a family trip somewhere exotic (Vietnam?), and buy a nice house closer to town where I work.
Thanks - I like this quote from Thero:
“That being said, we work for our shareholders, and while we’re not out looking for someone to take us over, if somebody should make such an overture we will do what’s best for the shareholders.”
He talked about EU in his Cantor talk (see transcript posted yesterday). They are looking at that.
This is also good news from the transcript:
and with the [R-it] outcome results we will be looking particularly after we publish at other geographies including Europe of course.
I like this from transcript:
we spoke with various journals who were interested in publishing this Vascepa type study \
We also without providing quantification indicated that the underlying data is supportive of that primary result.
I disagree - For something big like this, the PI will most likely do most of the writing of the draft and will be first author. Stats person will write much of the results with the PI, and underlings will help with the tables. Semi-final draft will be sent out for comments by all other authors late in the process.
>99% was being conservative
Raf - Yes - 10-20 minutes is typical talk length at big medical conferences. As a late breaking talk, it is on the low side for length - they block out a set amount of time in advance for adding multiple late breaking talks.
Dan - Given the numbers and statements made by the company, I think the chances of good results at AHA are >99%.
Thanks ZZ.
FWIW - This article (https://www.ncbi.nlm.nih.gov/pubmed/29760228) looked at MACE events in patients with DM2 and high CV risk over nearly 4 years. This may be roughly similar to the R-It population (with its relatively high proportion of DM patients). Hard MACE events (CV death, nonfatal MI, Stroke) were 64% of their expanded MACE events (which added in unstable angina, revascularization, and heart failure). Not exactly comparable, but suggests we can expect that about 2/3 of the events contributing to the R-IT MACE PE were hard MACE events. Secondary prevention sub-study in JELIS showed an overall RRR of 23%. Reduction in CV related death or MI (composite) showed a 30% RRR with EPA , although not significant due to sample size issues. A composite of nonfatal MI, unstable angina, or stenting showed a 21% RRR. This would suggest that hard MACE components in R-It likely will show a roughly comparable RRR to the 25% RRR on the primary MACE outcome.
AVI - Good points. Cut and paste could be fairly fast. A simultaneous release of NEJM pub with the AHA talk would certainly make handling embargo issues much less complicated.
Glad you liked the name
DM - I think they add raw numbers of events across all 5 classes into a single figure, and calculate the RRR from that.
JL - Cool - Can't wait to hear the details.
AVI - I guess it is possible. To achieve that, it would mean that they are now already submitting the publication (hope Dr. Bhatt writes fast). Could happen if they started the publication on the day of announcement (or even before), but it would be a very tight timeline to get reviews back and get the article accepted. Not sure if Bhatt would have been privy to results before the announcement, but think he might have been given that he was the PI.
Dan - I think they are both very important, and will be complementary. The journal article will be the most convincing because it is rigorously peer-reviewed (I agree NEJM is likely and the company's timeline is before end of 2018). However, the conference exposure will be the first place where details are provided, and should generate some good publicity if detailed results are as strong as expected.
CBB - I too thought his failure to state "we plan on going it alone, we are not taking any offers" but instead give a political non-answer, was telling. I thin he also stated that (paraphrasing) that "we will do what is in the best interests of our shareholders." Again, I take that to mean they are open to the right offer.
Also an entire sponsored presentation on V on evening of Day 1.
DM - I took that to mean that he was referring broadly to the primary MACE outcome, and was just listing its components. Certainly possible that this was a slip though, and he was referring to what he knows of the details.
I think the fact that expectations for detailed results are so low is going to magnify the response on Nov 10 when results show hard MACE and nonfatal MI were significant. Given the wording of the PR and the size of the overall RRR, I cannot imagine that at least these first two key SEs (first 2 tested in planned sequence) are not significant, with possibly others as well.
Congratulations Sam!