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will be much harder to get to stat sig with smaller sample size of those currently enrolled...
Laid off employees makes for good headlines in a battle w FDA. Plus they can backfill these territories w contract salesforce paid on commission...
Anyone have thoughts on how NCE delay now fits into the story now?
Feels like they may have granted if Anchor was to be approved. At the same time, they may still be waiting for anchor or even for Reduce it before granting?
Seems like the delay, relative to what we have learned in the last week doesn't shed new light, but am curious on others thoughts.
At $2 this is an interesting story for a new investor though a sad story for us in higher.
What does AMRN have
The best om3 drug in the market
Massive IP around that drug
That great drug is fda approved
250mm in cash
Ramping sales
Some chance at some damage mending on 20 dec
An outcomes trial which is ongoing w v good chance at making this the biggest thing since statins
Many ways to take stock higher than $2 if FDA issues Crl on 20 dec (sell to GSK; partner; contract salesforce, kill reduceitand ramp to eps profitability)
So for two bucks and if you know this drug is good, all those guys that got out on GIA announcement may be getting back in. It's the psychology of the mkt.
The FDA can indeed be sued.
I think the salient question right now is why exactly did fda move the goalposts on amrn?
This is the most important question to answer relative to the future of this stock
A few thoughts
FDA pressure from above after niacin and fibrates were embarrassingly approved and outcomes trials failed, and amrn had poor timing being the first where outcomes are needed
FDA wanted an out to conditionally to renege on spa to conditionally approve v based on reduce it.
FDA wanted an out to renege on spa for some other reason.
Amrn screwed up the process w FDA
FDA was influenced from the outside
perhaps some clue comes from the data point that (that I believe is true) that FDA a few weeks,back began to allow reps to distribute Jelis in a white,sealed envelope. If true, that means fda wants amrn to survive and wants to focus on outcomes and not trig lowering. Perhaps that is all they will give amrn.
Any thoughts on FDA and goalpost moving would help us all I believe.
Kc - best of luck!
From here:
If negative PDUFA decision joe must do one of several things strategically:
Sell for $ 5 plus $20 CVR
Bring on contract salesforce to ramp revs and help solidify supply relationships and bring down cash burn and wait for reduce it
Partner for sales and reduce it cost sharing now and take the pedal off the gas and ride BP coat tails into sunset.
But big money hopes are dead and we should all accept that at this point.
Can always sell for $6 and a bit fat Reduce it CVR. BP would do that in a minute....
FDA still wants Reduce It. Repeated failed outcomes makes them look bad. Feels like they moved the goal posts enough to get no out of ADcom but still leave room for conditional approval for Anchor. Conditional approval gets the coin to pay for Reduce It and if reduce it fails, they can yank anchor and fall back on the joke ADcom they hosted.
How many of those docs that voted no would prescribe V off label to their 400 trig pts today?
How many CAEs in the US in t2 diabetics since their vote?
We as a group convinced ourselves we were so right. We had more info than anyone else and all supported each other, creating invincibility cloak. Unfortunately we know much more than the panel and we assumed the panel would have somewhere near as much knowledge as us.
We as a group convinced ourselves we were so right. We had more info than anyone else and all supported each other, creating invincibility cloak. Unfortunately we know much more than the panel and we assumed the panel would have somewhere near as much knowledge as us.
Yes. Target event rate in the mid five pct rate. Seems line actual event rate is slightly below projection already. Maybe that is why they jacked baseline criteria to 200mgs
I thought we would see more buying at the end of the day. Probably short covering occurred early today when the stock opened green.
I dont think todays trading can be over analyzed. Plenty of time for anyone who wanted to put a bet on the table to do so, over a lot of different events. We have had a lot of bad news moments w this stock, the most recent of which were Lovaza Generic, Adcom delay fear and then of course the FUD generated by the BD. Anyone on the sidelines could have bought at any of those events. Highly unlikely that there were that many people who came up to speed on the story in the last 24 hours to the point they could now jump in for the first time on binary event risk, at least at the institutional level. If you like Anchor data, you probably knew about it a while ago and you were probably a buyer well before today.
Lets face it, there is a just a shitload of stock that trades out there in the float and a lot of people have lost money. Most big stock moves recently have been down, which makes moving up just on trading difficult as filling all those gaps with such a large float a monstrously herculean task. The bets are basically on the table. We are waiting for the river card now.
We will get a revaluation catalyst tomorrow and what I predict to be a blowout vote and early adjournment. We wont have to fill a gap if the company is indeed revalued.
What I fear, to some degree, is that Adcom 10-0 vote may not matter as much as we think. Big dumb risk averse WS money doesnt want AMRN to launch Anchor on their own. Maybe 10-0 will move BP. I just dont know the answer to that question. We cant like this story this much and BP not like it at all, so Joe Zs price must be steep. Does a postive Adcom move JZs bogey up again? One step at a time here, but at the end of the day, AMRN wont be a monster stock on its own and we will die of message board fatigue if they GIA on Anchor over the next few years....
This has been a fun ride, one of the funnest in certain ways, I just hope the light at the end of the tunnel that we all see is not an oncoming train....
I second that - good luck to everyone, and thank you for all the due diligence!!!!!!!
i think he would serve up some long john silver fish and chips and ask if that is enough omega 3 for a day!
quote:
harold bays was the 1st speaker.
the one who spoke highly of vascepa is terry jacobson the 2nd speaker.
i like how he say the group who is most likely to benefit
from vascepa is the diabetics who have high tg and low hdl.
i like how terry jacobson kept talking over and over about other trials that used a "non lipid lowering dose" of omega 3 FAs (gm or so). this sounds like a common phrase used among experts and if it is, discussion about a lot of the other trials gets thrown out the window in <1 minute tomorrow.
on top of this, it is very clear from this presentation that it is pretty well understood by experts that if trigs <150 no trial is gonna show a great benefit.
this is feeling very open and shut as long as if the panel wants some outcome benefit, the panel believes that unstable angina is a good enough outcome from Jelis to give the nod to V.
Lets hope for a lot of southern accents among the panel members, where omega 3 from food is almost non exist among their patient populations.
Moments of clarity can come at any time of day!
LOL^2
I like the post from earlier explaining lipid rises in anchor. Simply put, the wash out period was not long enuf...
Yeah, but this isn't safety...
Ps - how doe you add that previous message quote to the reply?
the only thing potentially "new" since FDA accepted Anchor under SPA was the Italian Study. In addition to all of this study's shortcomings, it clearly did not reveal a new safety concern, which under an SPA is really the only motivator for FDA to breach.
The silly PC study isnt even mentioned in the FDA BDs.
and if mineral oil raises ldl, then fda and amrn are harming 3000, going on 4000 people in reduce it who are taking it every day!
Volume has died down since this am. It was fierce in the am. Plus the huge volume Friday means a lot of bets are on the table. Id expect volume to be big tomorrow afternoon under the assumption the stock will be halted all day Weds. Tomorrow afternoon will be last chance to cover or place a bet...
Do we actually think that sNDA is not for adjunct to statin or was the Feb release by AMRN a typo?
If so, we are talking label expansion only on Weds? SR brought this up in his article today?
What do we think? If SR is right, could it be that FDA as already said ok to >200mg in adjunct to diet and that panel is label expansion? Seems too good to be true?
Perhaps maximum fud occurred today at 1035et/735pt.
This analyst is clearly frustrated as well and is venting her opinion of the open and shut safety/benefit of Vascepa. But fda not listening to her. We can only hope that the panel sees things as she does.
Not much new from cannacord, just another opinion but its as good as anyone elses:
We expect AdComm discussion to focus on how recent NON-Omega 3
outcomes studies showing equivocal outcomes benefit relate to
Vascepa’s ANCHOR indication, and if REDUCE-IT outcomes data is
needed pre-approval. The ACCORD, FIELD (Tricor) and AIM-HIGH
(Niaspan) outcomes studies, showed no CV benefit related to TG
lowering in patients with TG’s around the ANCHOR range. We think
FDA will ask the panel if TG lowering in this population may improve
heart health. We note, however, Vascepa is also associated with
modest but stat sig LDL reductions, widely recognized as beneficial.
Even if the panel decides TG is not important, they may find Vascepa’s
total of benefit (e.g. on ApoB, CRP, Lp(a), etc.) meaningful.
• We continue to think recent large-scale omega-3 supplement or lowdose
studies will not be major topics for discussion. There has been
focus on certain investigator sponsored studies that looked at low dose
EPA/DHA therapies that showed no significant benefits to CV health.
While these trials may be mentioned, we doubt they will be major
topics of discussion or real pushback on near-term ANCHOR approval,
due to design, Tx drug and rigor.
• We see 5% chance AdComm will demand REDUCE-IT data preapproval,
95% AdComm is fine with it as a Phase 4 commitment.
REDUCE-IT will not yield data until 2016-2017. In the unlikely event
common sense and any value placed on practical drug development
explodes, we think AMRN shares will go much lower.
Canna cord also defending...
I agree Ajax, FUD is maxed out. At the end of the day, FDA has to do some devil advocacy. Mineral oil is a softball and it would be ridiculous if they didn't bring up past studies to give amrn free commercial time and make sure all the asses are covered. At the end of the day Anchor is a huge indication. They have to take this seriously and have the ADcom ask and answer valuable questions.
It is indeed darkest before the dawn,.... Or until it turns pitch black!
A very interesting post from ymb. Either this short is impersonating a doc or the guy is legit. He has stated his name is Lior Elkayam MD, cardiologist, Miami.
investdoc18 • 3 hours ago Flag
12users liked this postsusers disliked this posts4Reply
FDA has allowed Amarin sales reps to distribute copies of Jelis
I know this first hand as I recieved a copy of it in a sealed envelope from a rep last Thursday. This means that the FDA agrees that the results of Jelis trail apply to some degree to the efficacy of Vasecpa. Given Jelis and Reduce-It with already 6,000 patients enrolled FDA will expand the label in December. Bought more shares at the close on Friday. Less
I don't mind the bds. At this point the thing that worries me is $5.75 equity offering. All the very confident language about spa agreements, etc could just be the company doing cya as they had some clue that ADcom had become an issue...
Chab
And that is why hopefully logic prevails. The ad com members haven't dealt w this saga. I love you all but want the last chapter of this book to be a happy one and one that occurs this year...
May be not worth 3 w generic Lovaza is Anchor denied. Reduce it Cvr would be worth more, I think.
If FDA reneges on SPA it must be because new info has come to light. The only thing new since they accepted Anchor is the Itialian study. That study is 1/8 EPA in DS form. Placebo is olive oil and patients at baseline are all over the place. I don't think that it is enough for FDA to renege.
Mineral oil issue is moot and should be explained away in one minute.
My question is why didn't Amrn include any of the aa/EPA data in their submission. Because it wasn't measured in the trial? I hope they can at least discuss this data with the committee.
The stock actually traded up for a good 10 minutes and then the news headlines hit....
In addition to Bloomberg, the very influential financial news service Steeet Account also posted that last infamous sentence of the BD pretty quickly after the docs hit.
Seems to have been a concerted effort by someone short to "help" uninformed reporters what to put out on the wires...
This all pure fda cya. If mineral oil was an issue, we would have seen it day 74 letter. Mineral oil used daily to help constipation. It's a well known entity. The FDA comments n mineral oil came from the statistician, not a medical expert. They just have nothing else to discuss.
Safe drug. Lowers trigs and helps LDL. Who knows on outcomes, but who cares right now. Do no harm? Yes. Help lipid profile? Yes. Why not then?
At the end of the day, this Adcom has nothing of any real substance to talk about. Trigs lowered?, yes. LDL lowered? Yes. Safety? Yes. Other risk markers lowered?, Yes.
So they have to fill the day re hashing mineral oil and talk about outcomes studies that arent even close to apples to apples here. There has to be something to talk about.
There is just basically nothing else for them to discuss...
and if they told them a long time ago, they didnt really have to launch Marine either...
Why is the FDA making AMRN go so far to prove there is an outcomes benefit without having one when they signed off the onSPA in the first place.
Devil advocate against themselves to CYA?
Also, the 2g Vascepa arm resulted in modest increases over baseline as well in ldlc. clearly the rise in ldl in all three arms shows that the causes of ldl increase are randomized across all three arms. At worst, as rich and other have said, we are ldl neutral versus baseline but given that 2g also incrased points to it not being that mineral oil raised ldl, giving vascepa an advantage...