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Good Lesson - My 14 year old son surprised me this year by asking for some Amarin stock as a birthday present. Got him 10 shares in mid-October at $18.50. All that has happened since then has given me a great opportunity to teach him about stock speculation and risks, options, margin accounts, inherent value, etc. I could not have planned it better.
JesusN is an idiot - He lost his shirt thinking this was going below $3 prior to 9/24.
Flip - Hope you are right.
Yes - Near perfect match with what we saw in the placebo group.
Bfost - That's great! Thanks for the info.
Flip - I am going to guess that Bigger has probably seen updated 2018 blinded data (under an NDA) as part of this funding round. Obvious that he would have wanted to see this as a condition of investing.
Raf - Hubert et al (1987) from the Framingham study prospective data reported that in men, LDL increased 7.1 points over 8 years in a sample aged 20-29 at baseline. This was pre-statin, so changes in treatment over time probably did not affect results much. I would assume an older group with high CV risk like R-It might have larger changes.
TTE - Agreed. The mineral oil issue does not have any bearing on risks of V, so it is a regulatory non issue from the safety perspective. From the efficacy perspective, not even the critics are saying V doesn't work to reduce MACE - they just say that mineral oil makes it hard to know the exact number. No one doubts it is effective at reducing risk, and it doesn't really matter if it is 15% or 26%. In a way, Reduce-It can be seen almost like a very large Phase 4 (post-marketing) trial - the trial confirms the safety of V and adds to that good information about efficacy. There are no roadblocks to an expanded indication by the FDA.
JL - So true. No medical professional is going to question a peer-reviewed article in NEJM. They are above reproach, have ridiculously high standards for acceptance of articles, and are viewed as the gatekeeper for the most important new medical information.
Exactly. For example:
Interview:
Herper Q: "What if I told you Reduce-It results show a notable increase in LDL in the placebo group, who got mineral oil?"
Responsible MD Answer: "Well, I might wonder whether using mineral oil could have exaggerated the effects of the study drug, but I would have to see more details to know whether this affected the primary results. Whether or not this is a problem would depend on how large those increases were and whether they were associated with actual MACE events"
Article:
Dr. so-and-so said "Mineral oil could have exaggerated the effects of the study drug," which may leave investors wondering whether all the purported beneficial effects of Vascepa may be questionable.
Dan - That's way too reasonable - taking responsibility for your own decisions. What are we coming to here?
CC - You are right - the real argument does not make for a good sound bite. The good news, I think, is that the large investors and funds have the expertise available to grasp these arguments and know sh!t from shinola, even though many individual retail investors may get swayed by wrong arguments and innuendo. Those big investors certainly are not selling - the R-It results are just as outstanding as anyone could have hoped, and eventually that will become the story. This may simply be an issue of waiting for the news cycle to move on to something else.
Sonam - Pretty positive overall, considering the source. Thanks for posting.
Disappointed with price action today and admit I was wrong about it only going up today, but I won't be wrong for long (a week or two maybe). I do have one comment about addressing the mineral oil issue - I hope they drop their argument that "this was an outcomes trial not a biomarker trial." That argument is a nice soundbite, but doesn't really make sense and is the weakest argument they have. The critics argue that the effect of V on MACE outcomes was exaggerated because of increased MACE related to increased LDL in placebo patients treated with mineral oil. The focus of this argument is on MACE outcomes not biomarkers, so trying to dismiss the criticism by saying R-It was an outcomes study seems irrelevant. I think they would be more convincing if they stick to the scientific and regulatory issues:
1) FDA approved mineral oil in the SPA, twice.
2) This issue was discussed with original V AdCom and was not considered important. It was approved.
3) Placebo patients with increased LDL did not have any significant difference in MACE events compared to those with no LDL increases (i.e., the "mineral oil increase" in LDL did not have any negative risk effects).
4) The group difference in LDL increase was 6% (IIRC), and that is not large enough to substantially alter the MACE reduction effect observed.
5) Even with the LDL increase noted in Placebo, the absolute values were well-within targets for adequate LDL control.
6) LDL might be expected to increase naturally over time, or because of regression (upward) to the mean in people specifically selected for low LDL as an entry criterion. The LDL increase in placebo may totally be an artifact (which had no effect on MACE anyway).
7) JELIS had same beneficial effect on MACE and had no mineral oil placebo.
8) If we for arguments sake assume the "mineral oil effect" was real (detrimental) and overestimate its impact as 20%, this means the "True" Hard MACE RRR would be nearly 21% - what other drug does that beyond statins? The answer is: NONE. This is still a game changer.
All of the above provide a compelling argument why this criticism is a "butterfly fart in the wind" (to quote HDG). The FDA is not going to be concerned this time with mineral oil any more than they were last time.
Makes sense - "regression to the mean." About 70 to about 90 in the placebo group and (ignoring intial drop at first post-treatment assessment) about 30 to about 60 in the treatment group. I would also just wonder if there is a time effect - in typical statin patients is there data that LDL tends to increase over time unless doses are increased (R-It was 4 years)?
AVI - I can see them fine in Firefolx
T2DM effects - Not sure if anyone saw in the NEJM supplement, but V apparently did not reduce new onset T2DM. Probably too much to ask for.
New Onset of Diabetes 65/1695(3.8%) 63/1697(3.7%) 1.04 (0.73, 1.47)
C reactive protein - an inflammation marker believed to be linked somewhat to CV risk.
Good point I meant more cannot be moved from its current path...
FYI - Regarding some of the Cardios cited in Herper article (conflict info from CMS):
1) Harlan Krumholz - received consulting payments of over $150,000 from Janssen last year. WAY over the national mean for Cardios. No idea what the could be doing to justify this.
2) Steven Nissen - Last year, more than $17,000 in consulting payments from AstraZeneca, over $10,00 from Novartis, and over $8,000 from Pfizer
3) Ethan Weiss - Over $6,000 last year from Janssen
4) Sekar Kathiresan - Actually has received $3,00 from Amarin, as well as $4,000 from Bayer and $3,000 from Merk.
NO! Totally wrong. No differences by sex.
One cardio quoted with negative spin in Herper article said today on twitter:
From a quantitative analysis, NO (a 12 mg/dl increase in non-HDL-C would explain about 7% RRR) IMO, the placebo increase doesn’t compromise the integrity of the trial result
Dan - Re: the Herper article - The fact that the Harvard colleague of Bhatt quoted had no idea about V's anti-inflammatory effects shows just how ignorant Herper's quoted experts are. I still think this negative spin is either an agenda, or ego (he is unwilling to admit he was wrong in predicting the trial would fail).
Y'all realize, I hope, that even IF mineral oil caused an inflation in effect sizes of 20% (which it didn't), hard MACE RRR would still be 21%. There is no story here. These crap articles with an agenda are just trying to get ahead of the real story (which is an immovable MAGLEV train going 300mph right now) to suit their own financial interests.
From PR (emphasis added. Approval of expanded label late 2019 but earlier if FDA allows priority review:
Amarin intends to submit an sNDA to the FDA in early 2019 seeking approval to expand the label for Vascepa based on the car dioprotective effect of Vascepa demonstrated in the REDUCE-IT study. FDA's determination of standard or priority review will be made when the sNDA is submitted. At this time, Amarin is planning for a standard review with potential approval anticipated in late 2019.
And the crowd is correct. Results indicate that V does NOT work by TG lowering. It is inflammation effects that matter.
OMFG - Outstanding results! Could not have scripted this any better. PPS is not going down on Monday
I know that dude too. Met him 10 years ago
You guys are nuts - the PPS is not going down after these stellar results.
AVI - That is what I recalled too. Just confimred in PMC version that it is still listed that way. Maybe there was an error in the original design pub?
Smarterer - Great catch. NEJM publication this afternoon about 2:30 if what AVI said about past similar situations is correct!
STS - Combined with statins, EPA causes plaque regression.
LB - Assuming the results of the Lovaza + Vit D study presented right before R-It results are negative or much weaker (almost surely they are), the obvious thing the discussant could talk about afterwards would be that maybe V works better because of pure EPA composition and different mechanisms of action (but higher dose as well).
Bfost - Great post. Totally agree (I have done the same type of consulting). Have fun this weekend! I am jealous.
A collective "OHHHHHH" in the room, or spontaneous applause, would be my expectation. And, I am going on record predicting that your numbers will not be that far off from the actual numbers presented on Saturday. The per protocol overall RRR is also likely to be amazing - potentially well above 30% (f they report it)
Marki - Not sure where you heard that but AVI has opined based on precedent that NEJM article could come out simultaneously with AHA talk.
TTE - Looks about right to me - make it so....
NY - I think the "rundown" in PPS this week totally parallels the rundown in PPS before topline. I think this reflects disbelief by many that results could be as good as they seem form the 25% overall RRR. This should add to the "surprise pop" in PPS after results turn out to be better than many think. I am assuming some big funds might be waiting on the sidelines to see what happens this weekend, and if results are like many here think they will be, will be buying in quickly in volume early Monday morning.
Chance of that is slim to none. I would guess about 20% RRR for revascularization, and higher than 25% RR for hard MACE (30%ish). I don't think stroke will have a high RRR (maybe 15%).
TTE - I think in JELIS subgroup analyses revascularization was numerically fairly high, but the RRR was lower than for MI or CV death. Same for UA, but R-It will have way fewer of these than in JELIS because of the stricter definition. Ignoring the clear positive wording used by the company on SEs, I agree that hard MACE at minimum is in the bag, and very likely so is combo of nonfatal MI + CV death. Only potential problem with CV death is testing order - revascularization will have to be significant, and while likely, it is not a sure thing (assuming it has lower RRR as in JELIS). We might end up with a good RRR for CV death that is considered only "nominally significant." I would say 80% likely that this is in the bag also though.