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Nice post. Yeah there’s still plenty of bears out there so we are good ha. We need the shorts so we can pop one day.
Some bearish arguments are
CRL
Remaining generic litigation Jan 2020
If Evaporate trial fails
Lack of supply to support demand.
Competitors like Azn if somehow that trial is positive or some subgroup secondary outcome benefits and they go to court and bust through our patent so they can market.
Lack of funding for a solid GIA strategy. They mentioned possibly expanding reps by 400. That’s nothing. I read something few months ago showed Pfizer had over 2 K reps at the start of their Lipitor launch plus all their millions for DTC etc.
All in all I agree we are greatly derisked. To me it’s a matter of “when”we take off not “if”
Not sure what you mean by checking old posts ?
Completely unethical to run another randomized controlled trial Vascepa vs placebo. Would never happen in US. Period.
Comments like they made make me think it’s coerced sorta like Tasty was saying. You don’t know whose behind these types of articles and influencing what they write etc. Ridiculous to call for another trial and actually would be unethical to run and subject someone to placebo.
Kinda BS how a medical organization like ACC will await the fda decision. That’s just disappointing. Kudos to the ADA for getting it right.
HDG posted a nice post about timelines. Adcom isn’t off table yet but chances are slim everyday going forward
Yeah I’m with you.
The short thesis is predicated on an adcom and possible CRL although this just seems virtually impossible at this point. Additionally, they’re holding onto the mineral oil argument and like Dan has been saying they don’t think we can GiA and do well in terms of peak sales.
Aside from other catalysts, I am lookin forward to our label and a guidance update thereafter of 1 plus billion for 2020 but hopefully more. This number is not known and many will be waiting to hear what JT provides as 2020 guidance. Earlier than expected approval (before 9/28) would be a nice gift as well.
Is it true that the short interest is higher now than pre 9/24 or am I reading this wrong?
If anything this bodes well for a pop on label.
I tend to agree with you and find your posts reliable. My Wall Street friends have similar thoughts to what you independently wrote.
I think a guidance update for 2020 would surprise them in order to show we are going to rise fast and peak sales will be much higher than predicted.
Also they tend not to take into account any of the other indications or world wide sales.
He’s said that twice now on two diff conferences. He’s misinformed to my knowledge.
Thanks dan
Maybe one day peak sales x 7 but not now. When you use that estimate are you saying a company should be worth peak sales x ~7 it’s first year with a label. Probably not. Takes years for it to be worth that.
That’s fair. Thanks.
Any guess at 2019 revenues (assuming label) since JT probably will keep us in the dark and you’ve been the most accurate to date.
Thanks.
You think we can do more than 2 B in 2020? I’m worried about supply. We need an update on supply.
Nice find. I like that article.
10 Million DM on statins with TG 150-500. Another 5 million in that category not on statins. Many more millions with TG < 150.
So this populations alone is very big not even considering the even bigger group of secondary prevention. However the article referenced in the presentation wasn’t helpful for these numbers surprisingly.
All in all it’s 10s of millions of Americans so getting to 10 billion peak sales just seems to be not a major leap.
Thx for your thoughts to help me explain what the people who are on the <10 Bill in peak sales team may be thinking.
I’m having my librarian pull the reference now from the amrn investor presentation (see below). I’ll look at it tmw.
They state in their old presentation
“population in label “
TG> 500
200-500
150-200.
Total is 70 mill Americans.
Therefore I think the 70 mill is likely close to the label population. Even if it’s not, and even if you assume no off label which is ultra conservative, you still arrive at 10s of millions of Americans.
Population data from NHANES [The Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on High Blood Cholesterol In Adults (Adult Treatment Panel III) JAMA. 2001 May. 285 (19): 2486-97]; populations of TGs <500 mg/dL being studied in statin treated patients with persistent high TG
Peak sales - To those that responded to rafs survey of <10 bill in peak sales, can anyone provide me with their thought process? I’d like
To hear your opinion. With probably more than 70 M Americans who can benefit upon a new label (70 M as referenced in any old investor presentation), how can you get Peak sales < 10 bill.
Are you expecting a supply issue? Or are you expecting to get a small small fraction of the 70M for some odd reason. I’m not saying they get to 10 B next year but I can’t imagine a current scenario where they won’t eventually get there (hopefully sooner than later)
Hi. Thanks. 35 percent as in what dollar amount per year ? did they mention what they think Europe is worth ?
Any mentions of supply?
Cardio, interested to get your take on Xarelto vs Vascepa review that’s being done. Do you see xarelto as a potential competitor in any way? I’m not sure how cardio community is embracing that xarelto data in CAD pts.
Thx.
Didn’t see this coming. Thanks.
Whose sponsoring this ?
Yeah I think it’s BS. I don’t see how they would get those kind of EPA levels. The source of the claim is below but I can’t look into it today. Will soon tho.
Maki KC, Orloff DG, Nicholls SJ et al. A highly bioavailable omega-3 free fatty acid formulation improves the cardiovascular risk profile in high-risk, statin-treated patients with residual hypertriglyceridemia (the ESPRIT trial). Clinical Therapeutics 2013;35(9):1400–11. doi: 10.1016/j.clinthera.2013.07.420
Well said. Nice post. Gives me the chills reliving the adcom tho ha.
Epa levels. Thx for the link. I didn’t realize the epa levels were going to be similar in the strength trial. Who knows what they mean by “approaching”
“STRENGTH will evaluate whether a 4g daily dose of Epanova — a mixture of EPA and DHA — gives a cardiovascular benefit to people with risk similar to those studied by REDUCE-IT. This dose of Epanova results in EPA levels in blood approaching those in REDUCE-IT and JELIS[12”
Thx for the polls. I’m curios what everyone thinks for peak sales 2020. Thx.
Priorty review and Adcom.
If we don’t get PR, I’m really going to be uneasy. I like your devils advocate convo with AVII. I really just don’t see how we don’t get PR unless they have it out for us to this day. I really hope more than anything that we get it. Time is money with this stock and it’s millions and billions if you consider 4 months time of peak sales. PR matters big time.
I already asked them last week. They couldn’t give me any info. Doubt you hear diff but never know.
I may have this wrong. I thought we had capacity of 750 mill this year. Now he says trying to double or triple. Was that of our 750 mill capacity. 350 mill was out revenue guidance. I interpreted it as 2-3 X the 750.
Okay. I agree with you there. Thx.
Hm just to clarify. You don’t think a pt that can benefit from Vascepa that’s not on a statin wouldn’t be prescribed Vascepa ? I absolutely think they would be. Or are you stating it just wouldn’t have a label for that which I agree with. And it’ll never have a label for that bc no IRB (in the US) would approve that study imo.
Yeah. I wish they would let us know max inventory for next year -2020. I asked IR and they couldn’t tell me yet. Obviously it’s not a guidance update but it helps to know max we can even hit next year if all stars align.
Read the history of statins. The point is if epa/Aa ratio of X reduces MACE in reduce it and another company (hypothetically) can do same or better, then possibility exists to get a label stating the above. A biomarker type label similar to cholesterol lowering label as in statins. It doesn’t need to say to reduce MACE. I’m not claiming that. The jump in logic will be obvious to some physicians tho and I think that can take some of the market in the future in this hypothetical situation.
Time will tell so if no one wants to entertain this idea that’s fine. It’s years down the road.
Multiple statins
Aight thanks for your thoughts. Seems like that’s the belief of a few people on the board. Time will tell maybe I’m wrong and I’d be happy to be wrong on this. Better for us.
I’m not sure I totally agree but I agree with some of those points. However let’s put it all aside. Forget about MTNB or any other company for that matter. I was hoping to get your opinion on an “IF” question. In other words IF a company can show their drug can get a higher epa level than Vascepa, do you see that as a potential Avenue to approval without an outcomes trial. This can be any Company not MTNB etc. just a hypothetical Qs.
I get your points. MTNB has a lot to prove etc. lemme get your opinion on the EPA level thought.
If amrn shows high epa/Aa ratio prevents MACE in tx or placebo group as you describe and I agree with, then don’t you think there’s a chance for a company to go head to head against us to show better epa level and then get approval based on that ?
My guess is this year we get that data for amrn and I am unsure of how competitors will react but I think the focus is going to be proving a certain epa blood level and bypassing an outcomes trial.
Been on market for I believe 4 years. It’s a PCSK9 inhibitor. Not a direct competitor.
This is the slides from a lecture on 4/24. “Reduce it data best by far”
Recommends TG>~135. Lot of references to our data.
http://www.eventscribe.com/uploads/eventScribe/PDFs/2019/6404/858856.pdf
AACE conf tmw-
Product Theater C: Expert Insights: Managing Cardiovascular Risk Based on the Landmark CV Outcomes Trial (REDUCE-IT™)
Saturday, April 27 11:15 AM - 12:00 PM Location: Convention Center Hall A
Yeah I see what your saying.
It will be prescribed by the masses. I think what cards is saying (and obviously he can respond himself) is the benefits were much more profound in secondary prevention. So physicians are going to prescribe well outside the inclusion criteria for reduce it there. For primary prevention, data is there but less dramatic. Some will stay in inclusion criteria TG> 135 but over time IMO we will be expanding outside of that range as well particularly when DTC advertising happends and they come in asking for it. For physicians to prescribe for primary prevention outside inclusion criteria takes time, conferences, talking to colleagues, talking with experts in the field, more data out of reduce it, etc. This happends with every area of medicine. An article comes out. There’s early adopters. Then as the data gets peeled apart and critiqued and presented at national conferences etc people feel more comfortable about it and prescribing habits increase.