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Seems positive but not blow away positive.
Failed at primary endpoint of low attenuated plaque
Beneficial for a number of secondary endpoints.
Mineral Oil no effect compared to historical controls.
Will need to see it at 18 months as perhaps the benefit accelerates across all as it did in RI.
I'm expecting $2.5-3 billion in 2021, a few years earlier than him. If they don't hit at least $3 billion in 2022 then management failed on their ability to generate sales. So I can easily see double that for peak sales (about $6.4 is not unreasonable) so $54 price target from Citi I would extrapolate if management can show sales like that can happen.
I would think if they had better insurance coverage, and thus could raise prices and not use coupons they might have been able to do double this years sales already.
I doubt it, if they don’t sell and then miss the number?
I guess 750 million will be somewhere in the 2020 sales estimate range and the stock will sell off a bit because its not 1 billion, and then they will do 1 billion and every quarter stock would jump on the beat.
BP is going to run there own estimates from their own experts all the way to 2029, what JT puts for a 2020 range will be irrelevant to them. What Amarin puts to BP for the next 5-10 years is what will matter because IF there is a BO it will only happen if both sides get to a peak sales number they feel isn’t cheating them. Amarin can’t feel it is too low and BP has to feel they can recover the investment in a reasonable time frame so they can sell it to their shareholders. If they don’t get to that middle ground it’s GIA for awhile.
I sold $25 calls for today looks like will work out fine. I will wait until EVAPORATE results Monday and decide if I want to sell more then. BO is unlikely until generics settled and FDA decision so reducing basis is always good while not expecting some large jump like that. Selling calls has Reduced basis by $3 over the last year this way. Always risk of losing the shares of course.
Seems like 10-12 billion is reasonable after FDA official label, EVAPORATE and Generics settle. Then it comes down to executing on sales and marketing, or BO. Since most of that is expected to happen we could get there anytime by year end. Even the worst case for peak sales mentioned makes it worth that, I mean the cash flow over the next 10 years they could buy the company outright on buybacks at those levels and market is forward thinking.
7:10 trading resumes per stocktwits
I noticed other stocks that came off hold in the am was on the hour, can’t remember if 8 am or 9 am but think trading will resume around then unless the BO press release is delayed until later this AM HA
If you are dead you are not going to be able to get a prescription for Vascepa, seems wrong but that is what they seemed to say.
I think they did full day halt, won’t trade until tomorrow according to someone on stocktwits but also no press release yet so maybe waiting for that
Panel seems to question Primary vs secondary so concern label will not be as wide as Amarin wants, but still pretty wide but lost in all the stress going on. Vote is coming within hour, clear FDA is approving expanded label, just what the label will be is the question. If not too limiting should not be too harmful. However, it will be take as negative by street depending actual vote, probably drop back to where it was before docs came out? Then slowly back up when FDA approves. All my guess but Adcom's are stressful and always have a lot of negatives from panel.
I don't think people even understand the real difference in primary vs secondary and what it means for future sales but it sounds negative to not get the label you are asking for which is definitely possible here.
And the bets advice is to do what you did, not hang on every word. Wait for the vote and press release. Above was the negative slant, positive slant we get primary or close to it, also still very possible at the moment
Panels job is to be critical, only need a half decent vote and critical comments do not mean a negative vote, I'd seen plenty of hard criticism in other adcoms and then they vote yes. FDA seems on board with approving for secondary, in 2013 Adcom FDA led the charge on negativity. These Adcoms always have lots of attacks from the panel, what's the point otherwise. I think vote is 4:10 PM ish, I'd say long wait is over but we probably have to wait for FDA decision in December now.
Inclusion requirements includes statin use so is in conjunction with statin
https://clinicaltrials.gov/ct2/show/NCT02926027
Since that money seems earmarked for the current deal and they want to cut debt not sure how they would get in on Amarin unless mostly stock deal.
https://www.ft.com/content/35602656-0561-11ea-9afa-d9e2401fa7ca
I could do without the stock volatility levels we've has to endure the last year, that's mainly where I'm coming from. JT has shown a good propensity to pull the Steve Jobs conservative guidance deal that always for earnings/revenue beats which usually leads to positive stock move after earnings, once all street cares about is earnings and not Adcom's, dilution and that stuff.
That will be awesome!
Not sure, there was a bio stock recently ran the few days before Adcom after release of docs, Adcom was positive and then just flat-lined as the docs already gave it away. We do have EVAPORATE next week as a follow up however and a large short interest(with today's volume and possible calls they had not sure how much it matters) but if we run today and a bit tomorrow Friday may see profit taking or sideways move even with unanimous Adcom, I suppose if FDA hints at limiting label we could see it down.
Very curious how it reacts Friday but EVAP results next week should give it some stability, hoping we never see the teens again with this stock! I said the same think when it hit yearly high earlier though.
Still be glad when we are past the Adcom but very reassuring that FDA is indicating expanded label, all that's left is the actual details of that population.
So we are getting expanded label as we all expected. Has anyone read the briefing docs and figured out what that label is likely going to be? How broad? How much does it matter?
We just can't know the short position reasoning, When you have heavy dilution like Amarin has experienced it could be a cause for short interest as a hedge, or as a way to add more for the coming run, for many possible reasons.
What percent of shorts are short with no long side option hedge? No idea. Amarin is very volatile which leads to lots of ways to play it and make money with the volatility.
Of course there are shorts that believe it's over-valued but I doubt that is the position of the majority of shorts.
On the flip side, if there are corresponding long option positions they would use those to close the shorts thus no real short squeeze would result.
Just too hard to speculate on the short interest, due diligence and science is what we got, I'm just going with that.
He's not really being negative, a bunch of people are overly sensitive. He throws out a random question based on new data and people go nuts. He expects approval of expanded label, so not sure why everyone is harping on him being so negative his tweet this morning was pretty benign.
The paranoia this stock causes is amazing.
It is night and day from Anchor where AF was pretty clear he expected them to failed and it to be bad, compared to now where he expects it to be positive and expects they need to answer a few tough questions.
He wants to write about Adcom and get hits, he wants controversy and newsworthy tidbits form Adcom. I think it is settling in that this is going to be an Ascom void of controversy and negativity so he will do anything to get something stirred up.
Anything possible but there is no reasonable reason for FDA to do that in this scenario
DO NOT SAY THINGS LIKE THAT RIGHT NOW!
Thank you
Those numbers are tiny and probably with health plans where the cost is no different hen generic OR the people just keep asking for refills and the doc just keeps saying OK. The numbers are so low it's not even worth tracking.
I've seem comments early on by him, don't have time to go back and search but this was discussed in the past, it's not new, it's just been overshadowed but it was brought up and debunked also.
This next week can't go fast enough.
Monday we will here what if Dr Bhatt gets the flu and doesn't show up, I heard flu season was already starting.
And finally, the FDA docs had one typo the FDA just found, Vascepa on one page was spelled Vacsepa and FDA may require they re-submit all documents.
It's just going to be one unsupported thing after another until FDA actually approves.
Science is overwhelming here, only a screw job by FDA can make things go wrong and I don't buy any conspiracy theory that it will happen.
Because MO has now been thoroughly debunked as an issue after JT comments about FDA does not believe is an issue and the good doctors comments. Shorts are getting nervous and now need to move onto some other random possible issue that is not an issue when you look at the facts, again.
Great Realistic Post!
I so want to not look at the stock price Tuesday with doc release until market is closed and then not look at it Thursday until I see a press release from Amarin Thursday night, seems anything else is just going to mess with the emotions. It really seems like what you say is so obvious if you take a step back, brains over emotions is hard with so much on the line.
They don't right now, I can't run any reasonable models above a $20 billion BO if I was BP and had to sell the deal to shareholders and the board. Assuming label expansion, generics case resolved, etc...
I think they'd buy it for 12-13B no problem, would they go 20 or above? Maybe in 6-12 months depending on label details, sales uptick, patent strength and other factor, I think they would
I found this which is old data but is about 25% not following rec
https://www.forbes.com/sites/matthewherper/2010/10/12/the-fda-ignores-its-advisors-a-quarter-of-the-time/#60db36203b97
True but almost 100% of the time they go along with a no vote, about 25% of the time they go against a yes vote, however, I don;t see stats for unanimous yes votes they go against and we are likely going to be in that camp, my guess is that is very low.
I don’t have the docs and was 100% sure would be discussed, if that’s all he has on a negative we are golden
12-0 in favor is going to happen
They can be disclosed under NDA and in private session so they CAN be used by FDA and Adcom members, the information just cannot be released publicly.
The open session is open to the public, the entire session does not have to be open.
It won't be revealed publicly but can be disclosed to Adcom and FDA
Those dates are the date of the short interest but not the date it was updated. The dissemination date is when they get posted
https://www.nasdaqtrader.com/Trader.aspx?id=ShortIntPubSch
November 11 after market close
I think many are thinking that and shorts expect that, which means docs are going to cause a run up not down
I don't recall them having backing from so many science groups or having comments from very prominent people as they do now. I do recall some individual testimony at Adcom thus must have been positive comments but pretty confident nothing like what we see here. FDA can do what they want, true, but the science is overwhelming here.
Cantor Raised to $35 as "generics lose on summary judgement"
No real worry but I think clearly that's the main debate at the Adcom, while everyone wonders if they get screwed over by FDA on MO the real debate is label size.
I think he's raising points that are worth discussing. He pretty much says he thinks the Adcom is mainly about size of the label which equals what most have said here for awhile. He has a high percent on secondary vs primary approval which differs from what most think here. I think there is enough to show primary should be approved but how will Amarin argue that point?