Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Why do you think briefing docs will have anything that bad in it? We've seen numerous detailed reviews, we already know the things it's going to say based on those. The only question is if FDA has a real issue with MO, but it seems like MO comes down to degree of success not failure/not failure so that seems irrelevant for expanded label.
I believe shorts believe briefing docs may give them chance but odds favor briefing docs are positive, so price is MORE likely to run up after docs released.
The Adcom members will praise the study and give unanimous vote IMO and that's all that matters
Evaporate will make that point kind of moot.
Makes you wonder if there was a planned bear raid to coincide with interview, if so that will now fail
Seems you have doubts about sharing so don't, the main point is you believe it would reassure those that doubt a fair FDA Ad Com and that's enough info for anyone here
Since you seem to have a nice discussion going on just ask her if it's ok to publicly disclose the info
If there is no reason not to post it then post it. If you obtained the info in a seedy or illegal way then don't post it.
If the actual releasing of the information could hurt Amarin in anyway then don't release it, not talking about what the news is but the fact it was put out in public.
I think in a year we'll know which way it really goes. I believe Buyout by end of next year barring certain events. I just think it makes incredible sense for all involved to have a BO and nothing JT has said leads me to believe otherwise. From need to "de-risk" to the options granted in a takeover(not just to management) I'm pretty sure the plan today is they expect to sell within a year, of course plans change.
The biggest issue on a BO is willingness to meet Amarin's price, I can run a financial model up to $20 Billion from BP's side, if Amarin wants, for example, $30 Billion then not happening now and I think that is pretty much where BO talks are today and why we are closer to a year away from BO than months. I think that changes in a year when stock price is up, sales have ramped, science keeps confirming EPA works etc. If they keep a high price then GIA will be the only option.
I disagree with some of the private equity comments, they sell part of equity in many cases because they are all about leverage, they also usually want management to buy in as equity partners so they have skin in the game. They usually have to spread there money around to various investments, so they choose how much they want to invest and then allocate shares to others. Then they have more money for the next investment and so on.
However, with that said, I'm not opposed to GIA and realize the benefit to that could be a larger than a BO though with more risk.
I think for Amarin shareholders we will get well rewarded either way so I don't personally have a strong feeling as to what I want, I'm just analyzing it from my point of view and feel this is the way it will go. Might be wrong, time will tell.
He's already stated his opinion, expects label expansion, small chance of worst case scenario where FDA asks for MO study first. I don't think hes' changed his mind. The expert he has on is positive on RI based on ST quotes posted from him.
Not worth $500, anything worthwhile(not!) comes out you'll hear it.
I've never heard of it, not sure the point, not going to change anything for public to get info earlier. This unanimous positive Adcom vote can't come soon enough, people are losing their minds.
The study had 50 of the 150 enrolled in April 2019 and requires 18 months each enrollee so not much info can be garnered yet
The evidence is overwhelming, this just adds to it, I have no doubts on approval and just waiting it out so since the chance of approval just went from 99.9999% to 99.9999% with that news not that big of news to me.
More importantly: Imagine the Brave results end of 2021 being very positive? Look at Biogen today on a drug that is very questionable on how well it works, just add 10 billion in market cap on just the hope of it getting approved and then everyone buying into it working.
Biogen is main reason, up ridiculous 33% because they are submitting drug that appeared to fail trials to FDA, market is crazy sometimes. But it's bringing up the sector. Biogen must be paying with stock for Amarin. HA
Can't we all just get along?
Seems like an unnecessary contest since I clearly won the Who is the smartest contest long ago! HA
Maybe they could call the study JELIS 2 or better yet just JEALOUS since everyone is jealous EPA works when EPA/DHA does not.
It was discussed on the board at the time, also posted on Stocktwits, it was one of his fireside chats or something along those lines
The one I was referring to the wording was different than below so don't recall which thing it was said but same gist below:
From H.C. Wainwright:
And over just short of 5 years, 28% of them had major adverse events in the placebo arm which was very consistent with what we expected in the study. We went into the study expecting that patients on an average would have 5.9% per year. These patients would end up having a major adverse cardiovascular event if they were not treated with Vascepa, but the actual turned out to be 5.7%, but our hypothesis was pretty accurate in those regards
JT commented the number of events in the control arm matched pre-trial estimates Amarin shared with FDA in setting up the SPA, I assume with all the statin trials, you could reasonably guess the number of events in that size population but he did not share the formula. He also stated they predicted and shared with FDA pre-trial the revert to mean of the placebo group #'s and that was expected as well.
It's called due diligence, simple as that.
You likely can't get a prescription without being on a statin, You've seen how uneducated doctors are then you see how bug supplements are, even ones proven to not do anything so the uneducated consumer will by OTC EPA in droves? I have no doubts the supplement market would make MORE money with a Vascepa approval.
I don't know, if you don't have an ownership position in AMRN by now, especially after all the shares available at the raise, why would you buy now and not wait to have it de-risked? Without some positive news not a lot of catalyst to buy, the sector is out of favor right now so program trading would be short.
I'm not sure BP has all this stuff to fear. Like what do they stand to lose? Statins are still going to be needed, the alternatives and add-ons are not big percent of any BP sales. When label expanded they could buy Amarin and then leverage pricing and other areas and get a positive return out of it, if it gets denied what value is it to BP?
Supplement manufacturers, maybe more to lose, but if it's approved how much more valuable are the words "epa"? It could help there sales dramatically, only negative is if Amarin somehow prevents them from selling EPA as a supplement but that's unlikely.
I think it's more market sector sentiment, hangover from large dilution and lack of news than the work of BP or Supplements as I don't see they have all that much to lose by Amarin approval.
Bhatt will be there, most significant advance in heart disease treatment since statins and you are the lead researcher you aren’t letting others say something about your research and not be there.
Nothing too specific, when the Adcom was announced I reached out to they/him/her (Go back a long ways, basically distant relative you might say.) basically said they had no concerns and that things were going to work out better than I was expecting. Basically I was talking $40 by end of next year, they indicated BO or GIA by end of next year would be above that.
Hard to say exactly how they would know MORE info than others, they have been around a long time and know a lot of people, I go with it's just an analysis they've done, Whether there are specific contacts they have above there own due diligence I don't ask, possible yes since the number of people they know is large but I'm just going with they have brilliant insights, knows more than I do, trust their judgement a lot, so gives me one more check box in the due diligence phase.
Kind of like having Baker Brothers say this to you in a private conversation, they could be wrong but they definitely know more than me and know more people than me so it would give you comfort. Not saying they have any relation to Baker Brothers(they don't) at all but based on a history the trust is large enough for me I would treat as equal to that in my mind.
It's not open label if he does not reveal which individuals had what result. He can easily present data and not effect completing the trial.
This is a risk tolerance question only you can answer, I think you can wait it out until Nov 1, only negative issue before Nov is the possibility Amarin received docs from FDA 2-4 weeks before public and something leaks out negative. Otherwise your probably Ok to wait it out, let option premiums drop a bit and revisit buying Puts hopefully cheaper due to stock price being higher.
Assuming you pay no worse then the current $2 for $14 Jan Puts you are worse case out at $12 and $115K profit after cost of puts, this assumes you have $70K to buy puts with without selling any shares.
If things go as most of us expect stock is $25 in January on it's way to $50 eventually and you lost $2 of profit by hedging.
The pain of seeing the profit disappear, in worst case scenario, is for you to decide how painful and how much risk, good thing is in almost any scenario stock likely stays above 6.70 basis you have just on current indication and potential could fire sale they could still sell the company for $12-15 a share.
YOLO is great, however, risking most of your investment money in one stock not smart, but it is the quickest way to get rich (and broke).
I have strict rules due to past history being burned on some individual stocks. If Amarin went to zero, realistically my life, happiness and future would not change dramatically, though it would suck to see money go but my good sized 401K is in the overall market, no Amarin at all so, I always have that to fall back on.
I'm 99.999% confident we get expanded label, 90% confident on patents since I have no skill there and knowledge is harder to find. I also know people outside the web boards (like in real life ha) that have way more insight into Amarin and FDA and they think it's going to end up better than I ever expected in the next year. Unfortunately the future is not guaranteed.
Best of luck on your decision.
Odds are very strong Adcom is positive and label gets expanded, however nothing is guaranteed, FDA will question everything, the only thing they can hold their hat on is MO effect and they brought it up in design of trial because they had questions from previous trial so its not like it's not coming up. So it will be stressful with release of docs and then Adcom, and then still wait on FDA.
You don't say what your profit is now and where your loss point is, you mention losing on options so want to avoid those but there are conservative strategies that can minimize your loss and let you play the upside.
You could hedge your position, you could buy Nov Puts but may need to buy Jan Puts to cover FDA approval time. Unfortunately premiums are high.
BUT if you want to walk away with no worse than $12 a share buy the Jan $14 puts for about $2, cost you 70K so your profit if it collapses to below 10 is whatever your profit is at $12.
In the interim you could sell 11-1 $18 calls for 75 cents and reduce the Puts premium a bit, you could lose the shares if above 18 but with the raise at 18 the odds of it being above 18.75 is unlikely, worst case you've maxed out at 12.75 for profit. You then hold through end of year and things go well the $1-2 Put premium will reduce your profit but stock will likely be up $10 more.
If you do end up deciding to just sell it all I suggest selling weekly calls until it's above the price and then you could still sell right before Adcom. Price is probably 16-18 range bound here barring market collapse.
So sell 10-4 $17 for .20 cents, if it is below 17 keep the premium and sell the 11th or 19th and so on up to Nov 1 and then cash out.
You could also cash out and use some profits to buy Jan 21 $25 calls, keeps you in the game, and you have a set profit
Good question on What are me missing.
Why would short interest go down 8 million and reverse and go up 10 million over 1 month. Are these really large short term traders?
Of course we've all seen increasing short interest up to big events not signal anything bad, but also seen where it seems there were people more "in the know". With calls so high could shorting be a hedge for large call option buying, they make call premiums and more back if it drops $6-8 but also make more on options going up than they lose on the short. When you get option premiums this volatile you just never know.
But I think MO has to be in the FDA documents and I think shorts may know that and know that mention may cause a drop, but is it a mention, a large section of the FDA docs? Seems lots to risk on Mineral Oil which I feel comfortable has been solidly debunked.
Could it just be algorithms and computer trading?
The fear always is someone know something...but at these short numbers wouldn't it be MANY people and thus word would be out.
In the end the "someone knows something" scenario is really the least likely so bests to think the short interest has no meaning or value in terms of what's going to happen in November and December but if the largest short position could announce themselves and their reasoning I'd appreciate it.
I arrive at the same conclusion, why would you add late breaking science and then announce:
"So far nothing good has happened but things could change in 9 months, thanks for coming."
Amarin always seems to be a case of: look at something logically the results should be positive for Amarin, and then between then and that positive event the stock flops around like a fish on land and then the positive result actually happens......and then dilution and insider sales..LOL
Could Amarin get the interim results from the scientists doing the study, present to Adcom panel and FDA with caveat the details cannot be publicly released until AHA but panel and FDA should have info for Adcom? Is that even a thing that remotely can happen?
Typical Amarin weirdness in that MOA will be a big question at Adcom and a couple days later evidence may come out that shows at least one MOA that has strong positive for Amarin.
November and December can't come fast enough, would it be ironic for FDA to hound on mineral oil, ask panel to vote on MO effect and then a few days later have evaporate show high level of success at 9 months.
I could see this whacked out scenario playing out: ADCOM docs released, includes vote on whether MO invalidated results, stock tanks to 12, Adcom vote says no by a strong majority but FDA still made it a vote so not sure what will they do, stock recovers to 15, Evaporate says reached 9 month success rate but want to see what happens at 18 months, stock to 18.
Then we wait 2 months for FDA as we debate will they require MO study or not, AND then they approve expanded label BUT require study on MO effect and if negative will revisit approval.....and a year later we're all still here doing the same thing over and over....the nightmare that will never end.
I can't believe this whole saga cannot be a best selling book some day.
I can't imagine, the IBB is down and on low volume days it tends to follow IBB, most people that had huge gains did not buy the day of or before and if you bought on the day of or before the news your likely a short term trader anyways.
We are in no man's land, no catalyst until November
Right, presenting interim result, but would anyone add late breaking science to a conference and not have something positive to report? If was negative, you just wait to 18 months and see if it changes. I think logic says the news will be positive but study would also continue to 18 months, same Amarin did with RI, could have stopped early on positive data but kept going to maximize the efficacy and data.
Nobody does that much work for free. Basically it's a full time gig going on with this. The question is what's behind it, a nutcase that lost a ton on a short and is on a vendetta, somebody paid by someone looking to short or get in low? It's gone on so long almost seems a personal vendetta make most sense.
Is it Joseph S. Zakrzewski trying to prove he's a better CEO than JT and should get all the credit 6 years later and actually undermining JT from the inside?
Inquiring minds want to know.
They created there response back in December of 18 before more detailed dives into data can be done, the analysis has been done on the issues mentioned but they just have not done the work to update it. Once FDA approves they will likely update their position, not much can be done until then is my guess. I doubt they will revisit the December 18 analysis with FDA decision in the near term.
It depends what's in the docs released a couple days before, there was nothing negative and no surprises in the docs for Aimmune thus the run-up. Amarin has much larger study and much more data, likely there is a little bit of everything covered, and assuming Amarin has been forthcoming no FDA-Amarin communication surprises and no large focus on MO then run-up a bit could happen.
What's your historical win %
Does it bother you that back-testing of TA indicators show that almost all of them fail to beat the SPY? SO a bearish cross or spinning top by itself is not something that you should just trade on.
TA is handy in certain situations and it can be excellent to see if bulls or bears are in control, especially using candlesticks, but even with all the candlestick indicators most also failed in back testing. As an example of one that worked:
Bullish Engulfing but not JUST Bullish Engulfing, if volume was over a certain amount, if volume was higher on 1 day more then the other and would need to go back and see what other caveats there were but in that case the stock was higher 30 days later with a half decent return. There was one other that back-tested to a positive ROI but happened even rarer than the Bullish Engulfing.
Somewhere around late early Sept you called for the stock to drop though reading the charts I saw higher highs and lower lows so I didn't get that call but you were stuck on one indicator and ignoring other factors.
I hope you do well with your TA trades, just seems like you don't do a good job on the AMRN analyses and are constantly pointing out Technical signals and attaching big meaning to them despite that proven to be a negative ROI approach.
I'm really, really comfortable saying no BO until after approval, makes no sense for anyone to do before then or would have been done already.
Pretty sure it’s a standard form letter type request. Meaningless thus no need to analyze or be upset over.
The late Adcom and uncertainty on nailing down the date gave a longer delay on posting than is normal as not normally as long a delay so waiting on it being posted for most is fine and no big deal as that’s when it’s official.
People seem to act like there was forethought and malice toward Amarin but no evidence of that.
They almost always move it 3 months but with holiday I think 6 weeks is more likely in this case
Incremental is "in addition to", it's going to be with statins, that was the RI population
I concur with your concur ! HA I think the recent FDA/Drug company political climate etc... played into an Adcom quite a bit and also why it went from none to hastily getting one done. Just a formality now, I hope, and think!
Maybe some on the street that are not looking into the details and just see late adcom, otherwise nobody with any knowledge seems to expect anything but label expansion, have not seen a single person come up with a reason why label won't get expanded but there are plausible reasons for the adcom, the lateness was disappointing but at least you can theorize reasons for the lateness. What nobody can do is theorize a legitimate reason to deny label expansion.
Didn't the AHA mention they have a forthcoming report on Reduce-It that was embargoed? I thought I saw that somewhere?
If so, wouldn't make sense to not have the reduce CVE in this report because the AHA has not actually given its full opinion on the study yet?