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Yup, been saying that all along. I've seen adcoms where the committee member will congratulate and heap praise on the team for studies that were well done with good results before they try to rip apart the study LOL and then vote 11-2 for approval.
There is always a negative slant as playing devil's advocate is part of the process but I expect a mostly friendly group of members.
I'm glad previous CEO was replaced, I think there is respect for current CEO and tons of respect for the lead researcher. I think those will both come thru loud and clear at this adcom, should be night and day from the adcom that should not be named.
I maxed out on Amarin stock but I am also not yet selling covered calls at this level, I expect it settle at least above 15 in short order and then maybe I'll look at weekly 16 calls to sell but not sure, prefer it was around 18, you can sell calls all day long up in that area. Anything I can do to slightly lower the overall basis is good and have 2 months where it should be range bound, just not clear what range it is yet.
The stock is just too low right now.
He also states it was probably positive and in the Forbes article before that also stated the effect was "not likely to be large enough to negate the results of the study"
So even the most strident opponents of Amarin agree the study was positive. Just the degree they question.
IS THERE 1 SCIENTIFIC/ACADEMIC PERSON THAT HAS SAID THE STUDY IS NOT SUCCESSFULLY POSITIVE DUE TO MINERAL OIL?
I have not heard of 1, has anyone?
Hike beat me to it, you can't enroll people in a trial and say, this won't help you and it might hurt you, please sign right here!
And that trial does nothing, does not tell you, no matter the result, whether CVD risk is increased 0, 1%, 50% or anything form the change in serum statin levels. Even a change in the level would NOT prove anything related to whether it adjusted the RI results and by how much.
The questions would keep coming, is the effect temporary, does it get worse over time, it was 18-24 months before Vascepa starting showing positive effects, what happens to levels at 18-24 months and on.
All it shows is whether or not mineral oil effects some absorption but unless it has ZERO effect you then have to run a 6 year trial.
Nobody in their right mind would do this trial. Someone has a heart attack during it and then you show a change in serum levels, well, you are going to prison.
MO is a stupid thing to talk about, the overall science is so strong it is NOT an issue, so if I'm Amarin I go with all the evidence and science and don't bother with a useless trial.
True, the delay is not fun but in the end this will all be ancient history and nothing we can do to change it now.
Thanks for the effort, never would have though to do that but interesting info, I hope and expect none of the request will come to anything or matter in the end but the DD is excellent all the way around on this item
You want to know why stock dropped on this news just read this board. Sheeesh.
My opinion:
1) Adcom will be positive for Amarin, expects unanimous vote but say 80% chance since there is always that 1 person...
2) Approval of label with no min. on cholesterol #'s-I'm as close to 100% on that now as I can be, have done alot of DD the last few days reaching out quite a bit, I personally thought we get a label with min LDL or Trigs or some limit that would be viewed somewhat negatively but I've been convinced otherwise.
3) January comes around there will be a lot of smiling faces from people on this board.
4) The fact there is so much panicking here is a direct reflection on the market price of Amarin. A delay is not good news but this is ridiculous nervousness, RELAX, Don't Worry, Be Happy.
5) Stock will be break recent highs in January, hopefully people that invested so much time and effort will stick around for the reward.
6) Am I weird that I feel no panic, no concern in the slightest on the stock price or any doubts at the end outcome? If stock goes to $3 it hurts me but perhaps the fact it does not become life altering helps, I guess, but it's not like I want to lose a lot of money but I think I've done the DD, I've looked at all sides, I've heard form some people knowing a lot more than me and I think that makes a big difference.
7)Market is being really dumb with its current price for Amarin
8) Wish Adcom was tomorrow, really looking forward to this as it is end game for the shorts. 94 Days to go...ignore the noise in the meantime, add if you can.
Last time it was because they did not have a study like RI as recent info at the time indicated improved lipid profile by itself did not mean drug would prevent heart issues, pretty easy call in hindsight, the change to the higher proof was last minute but was related to recent data so you can rationalize and understand why the last Adcom questions and results went the way they did, much different this time.
That's not the question, obviously it does not inhibit statins completely or even a lot as the lipid profile of the placebo group did not go to levels that they would if everyone stopped taking statins.
The question is did MO effect absorption to a level that would cause CVD risk to increase to levels that were found in RI trial. The Only study they could do is a 6 year study with a placebo and mineral oil and then see if the mineral oil group had more CVD. Of course, you CAN'T do that study because you are basically giving one group something that will not help them in anyway and might harm them.
So your left with a new study with Vascepa and no mineral oil, probably corn oil. But why? The evidence is not strong that MO effected the results so now you want 6 more years? While most scientists and doctors believe RI was a definitive practice altering study?
It does not matter the lipid change, the amount of serum statin concentration or anything else, just because those are effected has no bearing on whether they are effected enough to cause CVD. If they are not changed well maybe MO works in a way that this test doesn't show so you've proved nothing.
Jelis worked without MO. In RI The changes were not major over the whole study and subgroups show changes in LDL or other factors had no bearing, the FDA could approve label and request down the line study but I'm unclear what that study would be.
If there was a simple, short test/study someone would have done it.
A whole Adcom over mineral oil? What would that accomplish? Is anyone on committee going to come up with something not already discussed? This has been peer reviewed and analyzed to death where even the harshest critic can only say, yes Vascepa works but it’s overstated due to MO, if FDA believes MO was big issue they Just send crl saying you must do something to prove MO not an issue.
So what is the vote question? Is reduce it invalid because the mineral oil was not inert? Well that’s a slam dunk unanimous vote against. Are results overstated due to mineral oil? I don’t know why they would ask that question because it doesn’t answer whether Drug works or not so that leads back to the previous question which the committee will dismiss just like everybody else that has looked at the results.
MO is coming up and FDA is not convinced it is inert but unlike Anchor this data goes on for many years and does not show effects as time goes on
I think we get stuck on mineral oil because it’s the only thing that the naysayers have come out with That can lead to approval being denied or delayed.
The evidence that it is not inert and materially skewed results is just not supported in a way advisory committee experts would buy it invalidates results.
This Adcom can’t come fast enough
gregque is the user name
Can that ex FDA worker get some useful info to explain a lot more? I think we could have all guessed Nov 14 and Dec 28, they definitely would’ve won any poll here
I agree mostly, always thought an Adcom would happen until they took so long without announcing one. I’m not sure the size of population is a determining factor or not, how many drugs have ever been in front of FDA that had such a large population in the first place so hard to say that this population size is always an Adcom since so few drugs have this population. Common sense says it makes sense but hard to say historically it’s always the case.
It’s unfortunate Amarin does not feel like letting shareholders know what label they are requesting or anything regarding label discussion, that would help a lot in so many ways.
The Adcom discussion will be wide, about alot of things. Very curious to see what the voting questions entail, though long wait for that info.
Mainly I do not see true and real evidence that MO had a material effect or any other item makes the RI study invalid. There are clearly MO questions out there and FDA was concerned about it in anchor but science will make ADCOM members comfortable with that and FDA won’t have much to counter,
If there is a vote on “Did MO effect results” It would be an incredibly interesting ADCOM, if that is discussed but not voted on then the ADCOM is going to disappoint in term of being remotely controversial or interesting.
We have many peer reviews on RI and all conclude there is a benefit. ADCOM members will all have same conclusion and expect unanimous vote for approval but unsure on label since Amarin won’t share enough info.
IMO.
I think many of us have invested a lot of money, emotion and time and just want expanded label approved already and the frustration of another delay has been hard. We will all be glad to get to the FDA decision day, I expect we can all be happy then, definitely earned it.
Could be the larger label request by Amarin, could be the main committee on Amarin decided to approve label and passed it to someone above them for approval and they were nervous and said do an ADCOM, there are many reasons that are not nefarious
According to a guy on Stocktwits FDA has set PDUFA Dec 28 and Adcom Nov 14. Says will be made official soon and claims info came from FDA. Probably true even if he's just blowing smoke because that's 3 months from Sep 28 and they already said Nov 14 is likely. Guy is buying hard and bullish at least!
It's really all karmic retribution, if you were all around for the last one, it is so appropriate to have an Adcom and have the exact opposite result. It just brings us full circle, but THIS TIME is going to be so different! I wonder if there is some freaky numerology that ties the old date to the new one?
I actually have to, in real life, schedule a routine colonoscopy in November, I was thinking now I'd do it Nov 14 in case Amarin gets it up the you know what on that day I can feel it all emotionally and physically HA.
I don't know about that he was wrong about timing on everything and then kept changing his view and story, he even takes excerpts from the risk part of the filing in those tweets and puts in his own opinion in bold and brackets. I don't see where everything he said is coming true, he has said at one point or another every possible scenario just all ending with a negative outlook. Remember how FDA was going to stop EVAPORATE study because dangerous, not happened, not going to. He is paid to have an agenda so for the most part he can be ignored.
Well that would shock me but not the first time that would happen. I'm counting on that NOT happening and if it does will eat crow on that opinion(sure it won't be the last time)
Great post I got hurt by that last Adcom and should have known it was going to go south, so many hints ahead of time I kept thinking this doesn’t look good and still did not sell. We’ll get a good feel on this one a few days before Adcom but today I’m 100 percent confident in FDA expanded label, absolute no brainer 100% have no doubt so will look to see if new info changes my mind but so far nothing like last time.
I’d back up the truck if I didn’t have strict 1 stock exposure rules I religiously follow.
This is not the same Adcom. Might have an Adcom party!
Well the Blaha guy seems to like us
https://www.valleynewslive.com/content/news/Drug-with-fish-oil-cuts-risk-of-heart-attack-stroke-study-finds-500238342.html
“I think this is going to be a landmark study,” said Dr. Michael Blaha, director of clinical research at the Johns Hopkins Ciccarone Center for the Prevention of Heart Disease. “It’s remarkable.”
With all the negative results in studies looking at OTC fish oil supplements to prevent heart disease, “I think expectations were low for this trial,” said Blaha, who was not involved in the new research. “But based on the clinical trial results, I haven’t seen anything this potent in this group of patients in a long time.”
I don't think FDA was ready to announce the Adcom because they did not have everything 100% set. Amarin pushed them so they sent a letter stating that there would be an Adcom with a tentative date but not to release it until they put it in the official book because there was still open questions on the timing(also why new approval date not given yet). I don't think FDA really cared that much they just wanted to have Adcom date 100% sure and then new approval date set.....and the person that wrote that was probably not the brightest bulb. I don't underestimate the number of stupid people, I think FDA has a few of those involved with this.
Perhaps this FDA letter just came out of the blue and have to re-think these thoughts but I'm making sense to myself HA so I'll stick with it for now.
I listened to it a few hours ago on replay from the website
"Crazy Theory" is right thus not buying at all, market reaction also tells me that's not the case. JT was shell shocked last night, rather hear from him a week after the event when he has a chance to absorb, he had nothing to add last night, not sure what the purpose was, didn't calm anybody. Anything he said or acted like last night I'm just ignoring and not reading anything into.
It is possible FDA responded, as you suggested, to a direct question from Amarin based on info from FOIA but FDA was not going to tell Amarin about AdCom until it was definitively scheduled, based on the late date of scheduling it is entirely possible they don't have 100% commitment from the parties needed and afraid the date is going to change. Once they receive the confirmation that the people they need there are available they would have told Amarin but Amarin pushed them with the questioning.
Why would FDA, out of the blue, tell Amarin they would have an Adcom and a date but still not have listed it and told Amarin to wait on announcement? I think it is more logical that they just are not 100% sure of the date yet but were pretty close so instead of just saying there is an Adcom and date TBD they were waiting to solidify the date and that's all there is to it.
You have to believe JT knew an Adcom was coming though he specifically put out a press release saying they thought unlikely and in the filing for the shares they stated that one of the risks besides and Adcom is a delay in approval date, but added the fact that was highly unlikely or similar wording.
It was very clear to me on the call last night, very clear to me in the Q2 call that JT did not expect an Adcom because it was so late in the process. Otherwise he could now go to jail, why put yourself at risk of going to prison by knowing an Adcom is highly likely and lie about while raising money for the company?
The bankers on the raise advised them to do the raise, it's not unusual to raise money before a launch and when you have the stock at a 52 week high just before raise announcement. It's also not a JT only call, there is a management team, the board and probably input from large shareholders such as BB.
It's unusual for FDA to delay a date in the past few years but does happen, a few years ago delaying PR approval dates was happening a lot.
People are letting emotions take over, step back, look at it from afar, the MO issue keeps coming up, the indication is huge, the label request from Amarin is very broad, the filing was very large and takes time for FDA to go through, the FDA is not very efficient, lots of reasons things happened this way that don't need dark, dark, dark thoughts.
I admit the news is NOT positive, for sure, and the added wait is excruciating, but too many positives here to expect a negative outcome in the end. And then they need to sell the company to the highest bidder.
No chance. FDA just needs to check dates to figure out how far after AdCom to post the new date, we will get that soon enough,
Immediately? It depends on if CRL gives an opp to still get approval, say, in a year, I just can't fathom what a CRL would say Amarin needed to do to get approval, they have done everything they needed to do BUT assuming some bizarro world where FDA denies and Canada and Europe still approve it has some value because it is now a debate with ADA, AHA and the public need vs FDA denial so they should still get a billion in sales at some point, and add foreign commissions/sales maybe they can clear $1 a share in profit. Would eliminate the strong need for generics to come in early with a smaller market so a positive there, would need to cut back sales force and expenses.
Then after 2029(if not sooner) they should be able to push themselves in the OTC market and maybe residually earn 500 million per year that way.
With all that I see upside of about $10 and likely down to $5 range in the short term if CRL.
If other studies come out, such as Alzheimers or EVAPORATE that give potential for expanded label you could see potential long term for larger share growth but you are relying on other studies to complete and FDA to approve....so...study needs to be blow away results (oh wait they have that already so what we talking about...)
"If we get a CRL" is not something I care to entertain as a thought.
I can't believe there might be snow on the ground in New England before we get approval.
Someone needs to write a book on this stock when all said and done.
Ummmmm, NO.
On another note the 3 month delay is really closer to a month and a half, it is highly likely the ADCOM will make the FDA decision rather obvious.
Also, with Christmas at end of December likely have FDA decision by mid December, so 1 1/2 months to positive vote ad Adcom and 2 1/2 months on the delay to approval date.
Stop Being reasonable, doesn’t fit the mass hysteria going on. We’ll see if the conspiracy theorist have a foot to stand on by end of year, I don’t see any of it myself either but not an impossibility.
The cardio division misses dates more than anyone, up until the past few years FDA PR was almost always a few months late though the last few years almost always on time.
I think Adcom will be unanimous for expanded label, label gets expanded, what label is will be main question. MO will come up, will be discussed, Amarin has plenty of time to be ready for this,
This is an outcome trial, you would need a 6 year MO trial to see if it has same results without Vascepa on other side, not going to happen, a ST study on LDL or anything completely meaningless in terms of CV events so what else would they look at on the negative side? Not much. This is a once in 20 year change to SOC for at least a third of the population, the Adcom seems necessary, the timing I believe is a product of short staff and bad employees not some grand conspiracy to kill people because BP wants to buy Amarin cheaply or whatever the endgame is in the conspiracy theory, not sure I get what the endgame is in the conspiracy theory by the FDA.
Mostly agree with post, the Adcom panel list will be telling. FDA mentioned mineral oil before at Anchor, they will bring it up again, I think even the harshest critics have suggested at very worst case it enhance result but even if you determined an effect the results are still positive so I cannot see it derailing but it will come up and be discussed. Outside of that there is question of MOA that will be discussed.
It seems this will address a VERY large population of people and having an Adcom was expected....UNTIL they took so long to say anything, but is it railroading Amarin or just poorly staffed and poorly run FDA cardiovascular division?
The side effects are almost zero so seems hard for a panel to not be pretty unanimous in approving Vascepa, I'm sure questions will be there about label with LDL level or without but I expect a unanimous approval of label expansion and FDA will not go against that.
Very unfortunate for FDA to delay 3 months, killer for longs in the short term and just adds more stressful days to wait, but in the end no reason to believe this won't be approved. What are they going to say, run a new 6 year trial? Deny the drug despite science saying it works regardless of any placebo effect?
Wish had bought some short term puts, had sold a small amount of covered calls for this month but not enough to make up for this drop.
Hopefully it can settle back to at least 15 in short order.
Delay is Bad for the psyche that's for sure.
Label will have statins since that was RI population but for Amarin to run a study without statins would have been almost impossible.
With that said, many people stop taking statins for side effecst, and a reasonable doctor approach would be to try Vascepa without statins at that point, common sense would say it would help without a statin, which is different than an FDA study and label.
So I think it will eventually have many people taking it that are not taking statins
I doubt that's going to happen considering Amarin had not had label discussions as of 7/31. If it did happen need to know what the label was. The broader the label the better chance above 20.
Also is AHA going waiting to release embargoes report to see if FDA approves? Will they release a SOC related to Amarin at same time etc... if all that happened, yup over $20 for sure
Looks like Amarin lawyers requested a bunch of info related to MRC and any and all correspondence between MRC and the FDA
I thought he said plans to submit application for Europe, I don't recall partner by end of year? Was that in last CC?
Does not seem like capitulation yet. Fear drives corrections. This is a global economy, protectionism is bad for global economy thus bad for all economies.
I would guess China is going to let things ride until next election, if so Trump will keep ratcheting the tariffs. At some point I would guess Trump wants to get reelected so will come to a trade agreement, hail it as something great when in reality it will be slightly better than before and China will renege on most of it at a later date.
However, tariffs on both sides will back off and market will rally.
How long can Trump go considering China leaders have no fear of being replaced and can wait a year to hope Trump is out of office. If Trump goes too long and too far then a worldwide recession could temporarily happen.
These are the fears driving stocks down, mind you S and P is up STILL over 13% for the year, above the annual 10% average return so there is still some downside room.
So I'm looking to reach a 10% correction and then a bounce or float around there as they wait out the next move by Trump.
Though market timing is hard, you get lucky sometimes, I sold everything non Amarin and put to MM at the end of day on Fed rate reduction day(should have sold the day before but so goes market timing) with the idea of getting back in October 1 but this drop has me looking for an entry point already, have to see through the end of the week and see if we get any rebound or leveling off that sustains and will jump back in.
On the positive side a rate cutting environment is almost always good for stocks, P/E ratio's are only slightly high, forward P/E is slightly low. Fundamentals are good, unfortunately trade wars in a global economy are very bad.
The can't do that, they need to report when at 10%, they could never report and not have the share price skyrocket once they did, then Amarin says no and they have to sell at a loss after the crash after Amarin announces no deal?? They could never get 51% of the company for less than a reasonable BO offer.
It's just not going to happen that way here, EVER.
I don't think management is raising money based on market timing, no proof that market timing works, actually a lot of proof everyone is bad at it.
They put out pre-release of earnings to juice price for the offering, yes but what if Fed cut rate 1/2 percent and said would be aggressive and China and US had a trade deal, market is making all time highs?
To predict a severe 2 year global downturn so lets raise money seems pretty weird.
And historically September is the worst month of the year for the market, the market is only slightly over-valued IMO, this trade war fear will be a good buying opp, if someone can tell me when it's going to end I'd appreciate it. Put a bunch into cash from other investments the day the Fed announced the small cut though I do that a lot from August 1 to Sept 30. So if someone can tell me where the bottom is, appreciate in advance.
1) We don't know what price will be after approval, some stock prices hardly move after approval so while I agree it should be good for at least $2 a share there is no guarantee. You would still have street questioning when a raise was coming, questioning whether a small company can get sales up fast enough to justify the valuation, whether they would GIA, whether generics would get in earlier than 2029 etc...I don't believe approval is 100% baked in but approval is 99% expected, if label is broad stock will move up much more than just the approval. What if Trump signs executive order limiting Medicare prices they will pay for drugs, the sector sells off, Amarin might not get the pop because of that, so many possible unknowns to wait.
2) The market expected a raise after approval, a raise was coming, the filings all but said a raise was coming, launching a BB can cost 3-400 million dollars, it may cost 3-400 million to invest in expanded capacity with suppliers. It was going to take a monumental increase in scripts quickly after approval to avoid any raise of capital. A raise in capital was 90% plus going to happen,
3) JT NEVER said they would not need cash to market after approval, that's just not true.
4) In the grand scheme of things how much less dilution would there be after approval, I think people overestimate the price rise in the months after approval UNLESS there is a very broad label.
5) If it was $2 higher it would lose that $2 as soon as they raised after label expansion.
6) It's quite possible they are working on a deal to increase supply and having money available while negotiating this supply deal was necessary, in other words we don't have as much info as JT and management
7) It's all so meaningless, can they get to several billion in sales in 2021? If so stock will be $30 plus.
8) I personally agree they should have waited, since approval is all but certain, they should have waited to see what label exactly was since that will help determine how fast they can ramp sales and thus determine how much money they really needed
9) However, I all but knew they were going to raise money, they did it, they were going to do it, they like raising it vs. borrowing so that's what was going to happen.
10) Guess what? They got CASH for it, it wasn't free shares, they could go buy the shares back today and have cash left over, you have 32 million shares or so in around 18, selling pressure below that is low, yes algorithms will sell the market and Amarin with it but in a year, barring generics lawsuit win and assuming expended label the stock is above $20, this is all short term noise.
As long as JT is not the new Pete Carroll. Even a sure thing can be messed up by overthinking.
As of today you are correct and it is pretty simple as you say.
6 months from now we will see if there was info that we are not privy to that in hindsight the answer might not be so simple.
There has to be some analysis they did that determined this made long term sense.
It’s done now and they have cash for a very large promotion though I personally believe they need the money to invest in the supply chain and hopefully hear something related to that in the near future.