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I'm thinking the ADCOM will include nonstop praise for the study, a unanimous vote, 1,000's of people chanting, "We don't want to die" and with the IRS waiting for MRC to show up so he won't have opportunity to spread any FUD they'll need to approve November 15. 6 weeks out from that is December 19, so I think they can get this out just before the holidays and give everyone a Merry Christmas!
Having this date set is excellent news, I never expected it cancelled but still possible but those that expected something on the original date might be disappointed but not me.
I think with all the news recently on drug companies and FDA this large an indication was going to be hard pressed to not have an Adcom. And after the last one, Karma dictates we have an Adcom that goes the exact opposite way and 100% expect that here.
Anyone see Leerink note today, analysts speculates possibly not going to be a delay according to posts on StockTwits. If someone can get a copy be great
XERS was just approved but noticed they had specific reasoning as to why the 3 month PDUFA delay:
" the Company’s recent submission in response to an information request from the FDA constitutes a major amendment to the NDA, and therefore, the FDA is extending the goal date by three months to provide time for a full review of the submission"
Where Amarin has not been given an actual explanation for delay, though, I guess, the need for Adcom is the explanation, if we can understand the need for Adcom...
I wonder if the official letter on delay, likely out last week of September will list a reason for the delay other than need for Adcom.
This is even more impressive data:
“the event rate in the placebo arm of the REDUCE-IT study was consistent with, actually slightly lower than what we had reviewed with the FDA, prior to the start of the study, which would not suggest that the mineral oil was having any effect on event rates”
With all the statin studies that have been done predicting what the placebo group event rate would be, I think, pretty easy and a very good guide as to whether the placebo was inert. It’s OVERWHELMINGLY OBVIOUS Reduce-It was a success and that Vascepa works, there is ZERO evidence of anything otherwise.
oooooooh, just like a random cryptic tweet that everyone overanalyzes, love it!
There also continues to be solid action as next week's 16 call.
Someone posted earlier it was a sale not a buy, not sure if this is another one or the same one?
We'll see, the option action indicated $18 plus by next Friday, let's see if that happens, if it does then options action was meaningful, if not then you would have been correct.
Just suckering in the bears into a bear trap, pretty soon we have BBQ bear for dinner! I hope!
In all seriousness some follow through today would be nice, hopefully it turns around and ends up.
Looks like volume picked up around here so could be hitting support, a little more volume showing up on next weeks 16 call options.
JT sounded very confident yesterday, very loose, like he knows he has the goods, patience shall be rewarded.
If they sold Puts would make more sense as that's normally how you try to get into a stock at a lower basis from what it is currently trading.
If a news leak, not really sure what it would be, BO timing seems suspect, and move not big enough for that, the calls bought are all near term and around 16 and based on the cost leading to a 2-5 dollar move expected with any news.
Not sure what news would equate to such a move. Hopefully there is a news leak behind this and it is coming this week. Maybe FDA cancels Adcom...maybe Europe partner? Eliminating BO as option not sure what other news.
The person asking the questioned asked about the potential and mentioned the $10B figure as a number that's been out there, JT did not provide that # on his own
Stock up while IBB down, JT please cancel your fireside chat, don't want to ruin a good thing! HA
Your not adjusting the price for the 4000% dilution since then. We're actually way up! HA
They are just pulling it from FDA and they have not updated the date yet. Officially that is still the date since FDA had not officially changed it.
If I was running BP I would buy it now but I believe 100% approval is going to happen and believe you can settle with generics 100%. However, if you buy it now and those 2 things do not work out you'd be crucified by shareholders so why not wait a few months, and buy it slightly more once de-risked a little? Would Amarin really sell for much less today than they would in January?
Interesting numbers, sample sizes is so small not sure it's meaningful but still interesting to see.
I don't think anyone will ever run a trial without statins, if someone qualifies for statins then you can't take them off them to run a trial and if they don't qualify for statins then they likely have low risk for CVD anyways.
I think it makes sense the benefit is bigger for people with higher risk so if you ask would the high statin people come off statins and take Vascepa only see a benefit, probably but what's the point of that.
I don't see where it says without statins, it says "despite statins" several times meaning you should take it even if on statins, where does it recommend without statins?
How do you see that, does your broker list trade by trade detail for options?
I've kind of come to that line of thinking ASSUMING it was sell higher PUT and buy the lower PUT, if so I believe they then bought the Jan 2020 $18 strike with the money. If all true it makes so much sense and something I would do in a heartbeat if I had the funds.
Basically as long as stock is above $12 at October expiry(with no stock moving news event on the horizon very conservative bet), you then get to have Jan 18 options for free where stock should be over $20 and likely around $25 but anything above $18 is your profit. If it is not above $18 you basically get a wash, no gain, no loss. $25 close and you make close to a million bucks.
I hope that's what it was, if so, I love when traders find these niches and can make large bets with minimal risk. Someday.....it'll be me!
If they were sold and I don't have ability to see the individual options and if the strike was sold or bought but checking the recent price not long after the play was posted it did appear they spent the money and did not collect the premium from the puts.
If someone verifies they bought the lower put and sold the higher one then this play makes much more sense.
Do you remember what that other one was?
This is a bit perplexing with just this play, if you were so confident of it tanking why sell the $10, just buy the $12, how would you calculate it'll fall to 11 something but not much under 10?
Even as a hedge what's the gain, a savings of $2 a share?
Why October? Before the Adcom?
I like to put myself in their shoes but I keep coming up with nothing reasonable.
Going through list of explanations posted earlier
I don't see any that make a lot of sense.
1. Huge long position protecting against possible further delay of adcom. Seems better ways to do protection
2. Huge long position protecting against possible patent litigation news. Seems better ways to do protection
3. Trader with leaked information on further delay of Adcom. Possible but always discount leaked news, this big a trade is a big red flag to regulators
4. Trader with leaked information of patent litigation news. Possible but always discount leaked news, this big a trade is a big red flag to regulators
5. Market makers trying to scare retail into selling shares? Possible depending on MM position but this trade to do that seems like better ways to accomplish?
Another option someone is short and wants to exit the short trade with recent profits but wants to keep some skin in the game as sees downside momentum and took some profits and is playing for further downside but protecting much of the the short profits. We'll know better once short interest comes out in late September
It looked like higher put was at the ask and lower was at the bid so would be buying higher price and selling lower price thus bearish
Jan 2020 18 strike price Calls seeing some half decent volume today
Risk reducing bear spread, the fact they did it for October seems weird. Wonder if there is more to this play outside these 2 Puts.
Remember when all the high volume calls were bought for $30 and up and all those others in the 20's? How'd that work out?
I wouldn't concern yourself with any option spread or high volume Put or Call plays this far from any news. Most of the time it is some form of hedging strategy or some overall strategy that we are not privy to.
Couldn't have posted this information yesterday?
Wait, the CEO spoke and the price went up, am I awake, is this a dream?
I think that post sums up the general consensus of just about every person here.
I Trust in the information and due diligence done, I think I gathered a lot of information I would not have had otherwise form this board. I get quite a bit of extra confidence in info I've collected offline. It is funny to be 100% sure this is all going the way I think, but then watch stock go down and wonder, even for an instant, if there really is a nutty conspiracy theory.
There is not many things I can think of that would lead to the sentence
"I would find it hard to believe that the FDA.... "
1 or 2 or combo thereof with possibility of 5 thrown in there. I don't know how these Adcom decisions work but it's possible there is the group that reviews it and makes a recommendation and then it goes up the chain for approval and possible the initial recommendation was for approval no Adcom since it is a slam dunk and then "management" said for reason 2 or 5 or both that you need an Adcom.
Wish someone could get the FDA to tell us!
2.5 months to Adcom is more equivalent
They, of course, sold short but I would have though that was part of the 5 million increase previously, if all shorts would please announce themselves that would be helpful, thank you in advance.
And capitulation signs almost there.....
It's rough having stock drop from 23 to 14 in such a short time, anyone who had an account that has seen the money balance drop and drop is going to hesitate and think I'm done, just natural. Short interest is useful but when shorts are wrong they are every wrong. You think Amarin said we are selling no matter what tomorrow or 6 months from now, they would get less than 10 billion? In worst case scenario Amarin becomes a cash cow OTC EPA company generating up to a .5 to 1 billion a year forever.
ADCOM is going to be very positive and expect unanimous vote for an expended label, followed by FDA approval, odds almost 100% in my mind so let the algorithms short, let the street that says "Dilution followed by surprise Adcom, oh they are screwed" pile in. They have not done the due diligence to the level many here have.
If I'm right the short squeeze will be awesome AND the new shorts at that point will be minimal as growth rates will become staggering.
It went from 7.1 to 12 and then 16 just before and after approval, a high percent increase and a bad bet. Short sellers have limits as well, we just need good news to move them to cover.
Adcom was announced in between the short interest updates, trend followers and computer algorithms jumped in, if you think market is a headed south a volatile stock like Amarin moves at larger percentages so a good target, we will see what Short interest is heading into Adcom. A 15 million share jump was more than I expected even though expected to go up.
Considering the decrease in volume recently short covering would lift stock price if it happens without bad news attached to it and hopefully nothing but good news coming.
I'm more curious the trend in late October into November.
That’s not what this particular article/analysis is about. It’s solely about lowering trigs. Nothing in it is false.
Someone decided to write an analysis about lowering Trigs and whether EPA and DHA work to do that why would they going through any of that other stuff. People can write narrowly focused articles . This was not a wide ranging analysis of cardiovascular risk, it’s not an SOC designation.
It’s actually surprising they mentioned pure EPA and RI and reduction of cardiovascular risk at all. If anything that’s a positive since they weren’t even looking at that in this analysis But still felt the need to mention it
These updates come out all the time, nothing unusual here just too much hyper focused On Amarin people keep looking for negatives that don’t exist. This means absolute nothing for Vascepa and FDA and AHA future report.
Since FDA is going to approve expanded label it would be pretty weird to reach out to AHA, pretty weird to do that at this stage anyway but I guess nothing so thrilling as a completely made up mystery conspiracy theory.
Label expansion day can’t come fast enough...
Is from Yahoo board, trying to follow his logic, originally posted this link
https://www.ajconline.org/article/S0002-9149(19)30637-X/fulltext
Without knowing what they did could be either way.
It is probably a Long Straddle but doing it in September seems odd.
It seems a be a volatility play unless they sold calls to pay for puts or sold puts to pay for calls, then it becomes a different story.
Sorry for your loss, I lost a grandfather to prostate cancer, always tough losing someone, thoughts are with you and your family.