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12/27 judge rules on motions. Next catalyst.
See my post 12/13 1204 that it was approved.
Why is the ICER number so much higher that’s my qs?
I think what you posted may be most accurate around 7.9 mill. However I think it’s higher than that bc The data is old 2007-2014.
No. Not in my opinion. They may fight on the TG level if it’s prescribed for TG of 100 but I’d defer that to any cardiologist here to see if they have run into that.
This is going to get more and more off label usage as time goes on and insurance companies get comfortable with it increasing coverage with time.
Yes that’s a risk factor. Risk factors are left up to the prescribing physician.
Congrats all. Best board in biotech. Thanks to the other longs that have hung in there in the darkest of times. Thx to the regular posters who provide continuous updates.
Next up , bidding war.
Breaking news do you guys see footnote 54.
did they mean to write this.
“Because fda conducted its own analysis as described here and In the briefing document, which formed fda basis of approval for Vascepa’s SUPPLEMENT, fda will not address the validity of amrns Analysis and petitioners assertions regarding those analyses.
I can be way wrong but do they mean they approve vascepa supplemental app ? interesting wording.
Hey.
My comments
“MAT9001 was completely shelved until after R-IT results came out, they saw no value in it for the MARINE indication”
I see your point but I don’t see this as a negative. It’s smart if Vascepa was going no where at the time why chase that. Vascepa was in its darkest days until the Med literature changed with reduce it. Now that they have a broad market to chase they are going full throttle with Mat9001. Again not an important point to debate anyway.
lemme ask you something , assuming mat9001 is superior to Vascepa next year q4 2020 in terms of epa blood level and all biomarkers then is it going to bother you that mat9001 didn’t chase this years ago. It won’t matter.
“2) they are almost certainly going to violate AMRN MARINE patents if they try to market it, assuming they can actually afford to get it thru the P2/P3 and FDA approval process.”
I would disagree here. I think you need to do more DD on it to make that type of comment. Are you even sure our patents will hold against AZN? JT has stopped saying it in his calls.
More so just stating where they are at in the strength trial. There is no certainty we will win against them and no one on this board despite the vast experience is sure of the plan AZN is undertaking. No one can conclude they are definitively violating. If you talk to any lawyer and I have on both patent issues, there’s a case on both sides and really going to trial all possibilities are on the table.
Your theory on mtnb over time has changed imo. Your now basically stating mtnbs drug is almost pure epa and that the main downside is not having enough money for a CVOT. Not having financing does not mean the drug is bad and won’t replace vascepa. With the right partner that financing issue goes away. Plus they have enough money to get through next year. If their head to head read out q4 2020 is superior (in terms of not just biomarkers but also epa blood level ) then it’s a game changer.
Furthermore, mat9001 will come to market in severe TG market 2023 (BEFORE amrn loses its patents). I am long amrn but have a spec play buy on mtnb which I have disclosed multiple times in past and have received mostly disagreement with the iHub board here which is fine. It’s good to discuss pros and cons. However, Almost exactly what I mentioned with companies chasing the epa blood level is happening and therefore if successful some of these competitors will take SOME of the market. How much SOME is without a CVOT is left to be determined In the future. To be fair the market is huge so there’s enough to go around. Again to be clear I am just stating my opinion and want amrn to succeed but part of that success is understanding our competition thoroughly.
-Jo
Nothing would suprise me in biotech as we both know. I follow mtnb closely bc I carry a position in it. They have money to 2021.
Ya I hear ya. Its just bothersome to me that they can lump themselves into “our class” when this is very diff then prior “classes” in terms of Mechanism. Pcsk9 is clear. Statin and hmg co -A reductase is clear. Our mechanism is not so straight forward. Even if they can claim epa blood levels are similar to us you don’t know what effects the other components can be causing (dha/dpa/phospholipids etc).
Thanks. Yeah that answers some of it. Just seems slightly unethical for a pt to get let’s say ACSTs drug for 5-7 years with the data out on Vascepa currently. I can understand a trial
That started or is ongoing (strength) but for an IRB to be approved now it seems hard for me to understand how that should fly.
I guess like you said it depends if they consider them part of the class. It’s sort of a mixed bag because they have epa in them but the other components should make them distinct entities and not worthy of class effect (eg MTNBs DpA which has been correlated with stroke and ACSTs dha/phospholipids whose effect on CV outcome is unknown).
Qs for the board. In the US, it would likely be unethical to conduct an outcome study of MTNB or ACSt drugs given the value a patient has being on Vascepa. For instance a patient can’t be on Vascepa and Mat9001. How can someone be enrolled on one of these earlier phase drugs if they stand to benefit tremendously by being on Vascepa.
Therefore how would these companies even conduct a CV outcome study ? Any thoughts here. I can’t think of an example of this currently.
Agreed. That was an impressive bear attack. Call it a raid or what you want. You just can’t put stops in with this stock and you can’t sell in a panic. Smart people on the board accumulated more. Next up is pdufa date. Who wishes it was 12/28?
It may not be a good idea to send more info to the fda. That may lead to a delay in our pdufa date.
Insurance companies have ruined healthcare. I think they are the worst. However they do like cost effectiveness and standard of care guidelines. Let’s all hope for a wide label to make the issue settled by 12/28.
JL. I agree with you here with one caveat. It seems to me with Vascepa being in every important CV guideline as standard of care (secondary and primary prevention) as well as being extremely cost effective it remains to be seen if insurance companies will cover it well based on that alone. How wide the label will be may not be AS important as we all believe. Obviously it has value but we may get decent coverage without a perfect label.
I can’t say I know of another drug that fits Vascepas situation. What are your thoughts on that?
Ischemia triAl. I bet you Medical therapy group had people on Vascepa.
https://www.acc.org/latest-in-cardiology/clinical-trials/2019/11/15/17/27/ischemia
G thanks for the update. For Jan 3rd, is this your guess of when we get a 2020 guidance or did I miss amrn mentioning that date?
Thx for response. Just literally trying to digest today’s events. Mind blown today in all diff ways. Some of those panelists were horrific.
Help- I missed one section of adcom and came back on to hear consensus was committee doesn’t want deaths included on label for CV risk reduction. Can someone help me understand whatever ridiculous argument was said or what I heard?
Excited about 16-0 but wtf.
Good qs. I think there’s still
Going to be some question until label is out. However after tomorrow if there’s a decent agreement we should have a more clear picture of what the choices are (e.g. whether TG is on the label or not ). I’m fairly certain TG > 135 will be on the label.
https://www.abstractsonline.com/pp8/#!/7891/presentation/26699
slowing cognitive decline.
Anyone know what drug they used? It wasn’t Vascepa but they used high dose epa and dha.
It’s hard to disconnect. With a few days to go, it makes us want to fast forward to Thursday. I’d like to say I’ve been as long amrn as anyone else on the board here (pre marine etc). I’ve taken profits along the way and also held in the red during the dark times knowing the future was bright. Wishing all good luck and remember not to sell yourself short when we pop.
Really great find. Thanks for posting.
Some new slides/figures I have never seen before. Q A at the end was very informative to see how Bhatt views reduce it In the context of the ongoing trials. We on the board know the mineral
Oil is a non issue and he reiterates that. I think we get a label similar to guidelines Including both primary and secondary prevention for TG> 135.
Adcom and label are very much NOT baked in. We continue to see shorts/bears post negative comments and articles. Thanks to all on the board who continue to contribute. We are almost there.
Looking forward to
Adcom
AHA and Evaporate
European submission
Label
2020 Guidance (JT mentioned he will provide after the label. How long after we don’t know but this can be a huge catalyst).
Anyone know when we will know definitively if Bhatt will be at adcom ?
Just bumped into another doctor at a wedding. He prescribes lovaza. I just spent cocktail hour educating him on vascepa.
#every customer matters
99 percent.
Agree raf. I’m up to a 99 percent lock in approval. There is not one trial that hasn’t been scrutinized in the medical literature. I challenge anyone to find one. I attend regional and national conferences many times throughout the year. It takes months to years to digest data as people look to scrutinize and see how good the data is. This has stood the test of time for about a year now and honestly every time you read it or follow the subsequent articles that come out from reduce it the data looks stronger.
We are not beating guidance with these numbers. we need better growth. really wish we had a feel for 2020 guidance. JT needs to get aggressive and give us over a billion. I’m looking forward to label and eventual 2020 guidance.
I think that opens up pandora box. You don’t want to (at least not yet ) have a lab value that can show it directly was the reason for reduction in MACE bc other companies can then potentially piggyback us by getting to a certain epa/AA ratio with a certain dose of a med
I still think that’s why amrn hasn’t muddied the water and released that info prior to approval.
Lastly, amrn doesn’t need to run anymore trials. The off statin population is going to get this drug off label. The market is massive. Waste of amrn time to do that study if they get a good label and it takes off as well as hoped.
Mtnb- I know a few of you including raf have gone back and forth with me on this. Today they announced they are going after not just TG> 500 but also TG 200-499 without an outcomes data and just a head to head against Vascepa. It remains to be seen if they will be allowed to do this. They seem to think they will be able to. I think that’s really messed up if they are able to do that but I am also disclosing I have a small position in MTNB to hedge amrn competition.
Seems like most on the board don’t think they can do this and hopefully that’s true.
Question for Board On Europe. How much up front money do you think a BP would pay for Europe?
I noticed that too and thought that was one of the only negatives of today’s call. Azn path has always been unclear to me. JT has said on prior calls he will defend patents vigorously yet today he led investors to believe azn can market their drug after strength. Unusual word choice.
Rest of conf was fairly bullish.
Plus you got your 10 B peak sales mention you have been waiting for :) Just wait until label and 2020 guidance update. That’s when we fly.
ESC Guidelines Update
https://academic.oup.com/eurheartj/advance-article/doi/10.1093/eurheartj/ehz455/5556353
The main update for us is below
In high risk pts with TG 135-499 despite statin treatment, icosapent ethyl 2 G twice a day should be considered in combination with statin.
I need to look at the full article. Interesting. Woulda liked to see a benefit TG < 150 but that was the comparator group.
I will. Haven’t sold any and bought more in long term options.
Know what you own. GL.
Fair point.
I guess two diff things
DM risk factor primary prevention will def be on label for obvious reasons.
What I was referring to is all comers with TG > 150 for primary prevention.
“
If anything R-It tells us that TG levels don’t matter much . Benefit is regardless of wether TG was 200 or 100 .... so why approve a label for lowering TG levels alone ? “
Why approve a label for TG lowering alone? Well you can argue lowering TG levels matter in combination with lowering other lipid biomarkers and lowering overall systemic inflammation. The point is we don’t know that TG levels didnt matter. Maybe they matter at > 100 but not at 95. We just know 100-150 and > 150 did the same. We haven’t found the low cut point yet because it wasn’t tested.
Alternatively, maybe they don’t matter as JL has pointed out. Scientifically it makes more sense for TG to be a marker of disease rather than a lipid value to seek to lower. I don’t think any of this has been confirmed yet and even Bhatt continues to admit ‘some’ of the benefit was from TG lowering.
In answer to your other question , “Show me the data that supports lowering of TG’s above 150 ...alone ... reduces risk of heart attacks and strokes”
What we have is an at risk group of people with TG > 150 showing benefit (really > 135). It’s very hard to prove a completely primary prevention argument for all comers with TG> 150 but off label it’ll be prescribed until more data comes out. You always study a disease first in the sickest patients because they stand to benefit the most. Many people died waiting for reduce it. You question if many more will die waiting for a primary prevention study to commence and complete (if it does wind up being done and is positive). Question is will the fda allow treatment in that group based on the available data. I never said they would but off label it’ll be prescribed.
Hope this helps somewhat.
GL.