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dmiller
Yes it is desperate. They lost. I wasn't suggesting that the stock was going to rebound to $20. Just pointing out they have nothing more to lose. Are you saying that a doctor who writes a prescription off label for a patented use can't be held liable?
I have heard it stated that Amarin can't sue doctors and insurance companies because they just can't afford to risk their reputation etc. But as a one drug company with nothing to lose in the US why not? Why not sue everyone every time? BP may even back the effort since they lose out all the time and have legitimate reasons why they can't afford the reputation risk. But Amarin literally has nothing to lose by suing every one who prescribes off label or pharmacies that switch off label.
Maybe some law review will write a piece on the new precedential ruling by the court. When the 3 judges read it they might wake up.
marjac,
If the other two mostly silent judges didn't have questions because they were on the side of the generics and the one judge with questions was hostile to Amarin then they wouldn't have had OA would they? Seems to me that the only explanation for both OA and a lack of questions by two judges would be there was not consensus among them which would mean the silent parties found some merit in reversing?
Very funny HG. But Kiwi how do you qualify for a check? Unbelievable for a CEO even if retired. The cut off is pretty low.
Lem,
Definitely not suggesting to sue the doctors. I am suggesting that any new carve out for Marine induces infringement on Reduce It. Those patents did not exist in the orange book when the generics filed but they do now. So does Amarin get to use the Reduce It patents on any future litigation on an ANDA for Marine? That is the question.
Lemmi
You didn't really answer the question. I know its for the indication but the question is assuming the Reduce It patent is valid granting the indication for Marine would cause inducement to infringe the Reduce It patent due to off label use. Is this argument valid? If so settling makes sense despite the Marine patents current standing.
HD - if they did settle with these two and a new ANDA was filed would they be able to block with the recent Reduce It patents? In other words do any new FDA filing have to beat both Marine and Reduce It patents on inducement to infringe?
At some point you get Herd immunity. You get a point where the spread slows simply because there are less carriers since there is more immunity.
JL,
I would be interested in your take on this study on COVID 19 on ACE and how it relates to Vascepa.
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30116-8/fulltext?fbclid=IwAR3JIofgsqTlRP7z5dZ-qnx4yXhW-RtJ7f6FOPXvXQedOfxvRMxTCVcnme8
The run on toilet paper may have started in Japan. A person there posted the stores were running out (they were not at the time) and there was a run on TP that wiped out all supply in a day. I talked with someone who lives there. Crazy. You could see a run on Vascepa if someone had “first hand knowledge that several patients in a Washington nursing home were spared all of whom were on an anti inflammatory drug known as Vascepa”. The more the media picked up on this might Not be true the better because some would then assume it has to be true. At times like these people act crazy.
Jasb
If I were guessing we are 2 months from max fear then 3-6 months from the realization that you have to move on with life. Right now most people don't know anyone who has the virus. Once that changes and social media amplifies the connections with people who know someone who know someone then we see things come to a screeching halt. A little panic now may actually be good so stores and restock when the real panic and stupidity hit. I am just hoping AMRN gets the court win before any of that happens so I can make some moves. If not we will be waiting for 6-9 months IMO.
STS. Not sure what you’re looking at. Hard to believe any one invested in a bio hasn’t heard of IBB. Look at the link again.
STS. FYI. AMRN is in the IBB
https://www.ishares.com/us/products/239699/ishares-nasdaq-biotechnology-etf
Read Post 237635
Portugal - Delivering yesterday's cutting edge cures tomorrow.
Is any of this because of the people who got their calls automatically executed and now have a margin call for more shares than they can afford and worse now under what they executed for?
I too picked up my 3 month supply on Friday for $9. Weird thing is i got a script for my son for adhd lower dose. 1 month supply 1gm a day $75. He is under 18 was the reason he couldn’t use the coupon or it just wasn’t covered. But I have no risk factors and normal trigs so completely off label for me too but I am covered. Same insurance. Who knows how they do this.
It was my understanding that because the label is for the same treatment they can substitute. Once the label changes then it should not be allowed to be substituted when written for cardiovascular treatment.
The drama started a year before the adcom when the FDA would not grant NCE status and the company announced go it alone. Months of orange book updating that ended up going to court to get NCE.
Read it too quickly in the link as 2019 vs 2009
I thought you retired?
What I don’t understand is why another hedge fund doesn’t smell the desperation and crush who ever is behind this. One shitty analyst can’t move a stock 10% on their own.
VuBru. I have heard of firms initiating coverage then making calls to clients to buy but I hadn’t ever heard of initiating coverage then searching for clients who already own and telling them to sell. Do you know if that happens often? Or is it highly unusual?
I really hope there are bears trapped lower and this is a bs report trying to get them out. If it's true the greed on wall street will smell the blood and ruin them. They have no friends so if someone suspected there was a large position underwater they would pound it. Hope that happens tomorrow. But it could just be one idiots opinion.
https://www.fda.gov/media/132476/download
JL - instructions are here. You don't have to pay. I just logged in. Need to download adobe connect. Instructions also in the link. They are setting up now.
North
The source is Thero. He said it on a conference call. A good question of the company would be if they have seen a change in the duration since reduce it results.
Interesting options activity this morning. 10,000 contracts for Nov 15 Calls at $21 for around .53$ and 10,000 contracts for Nov 15 $12 puts around .73$.
A reporter being tipped off by a government agency is hardly a conspiracy. Thinking that AF is part of a big plan is. Of course he could be the smartest person in healthcare and predicted the FDA would want an outcome study when no one else thought it. I just don’t think he is that smart. He is a reporter that talks with people at the FDA and someone hinted or told him.
The doctor backs out or AFs interview that everyone was convinced was going to be a hit piece. The conspiracy theory falls flat on its face here. AF doing an actual interview with someone he hasn’t prepped and doesn’t know who STAT is. A real attempt at reporting. But completely overlooked by the conspiracy theorists. At the same time there is no doubt in my mind that AF was tipped off that the FDA wanted an outcome study prior to approval. Probably by an FDA that didn’t want it to appear out of left field since they agreed to an SPA they shouldn’t have. My guess is that they weren’t only not convinced by trigs but also questioned the whole statin theory. Those trials were questionable. AF is too stupid to just guest that the FDA wanted an outcome study. He is/was a pawn who’s time has passed. Sucks to be him. No longer needed by the insiders and actually having to work. He made snarky remarks because he thought he was a big deal when he is actually just a tool.
Supplement? That word is concerning.
Haven't had a cold sore since taking. Also, no more migraines. Also no more planters warts. No more dry skin on my arms in the winter. Unfortunately didn't get TTE's side effect.
Does anyone think that 10K Call purchase that laid out $1.5M was due to someone seeing the briefing documents sent to Amarin?
Moon,
I wasn't talking about the FR notice. The letter sent to Amarin that caused the 8/8 conf call was dated earlier than 8/8 I thought it was 8/1.
What was the date on the letter for the Ad Com? I think it was before the 5th but can't remember. That would be telling. Also, the FOIA were on the 7th I believe.
How do you know your prediction is wrong? You have to actually schedule an Ad Com before you can cancel one.
These were the draft points to consider from the briefing docs:
1. Please discuss the efficacy results from the ANCHOR trial, including the clinical
significance of the observed changes in lipid/lipoprotein parameters and your
level of confidence that these changes will translate into a meaningful reduction in
cardiovascular risk among the target population.
2. Taking into account the described efficacy and safety data for Vascepa, do you
believe that its effects on the described lipid/lipoprotein parameters are sufficient
to grant approval for co-administration with statin therapy for the treatment of
patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the
completion of REDUCE-IT? Please provide the rationale underlying your
recommendation.
Does anyone have handy the actual voting question asked at the Ad Com?
"This three-year form of exclusivity may also not prevent the FDA from approving an NDA that relies only on its own data to support the change or innovation."
Could this be part of the reason the Epanova trial continues?
Raf,
I think compliance is somewhere in between. If I get a prescription no matter what there is some kind of copay. I would argue the larger the co pay the higher the compliance. Those in the trial paid $0. So while some people don't take their medicine that number has to be higher when there is no skin in the game.
Steven Giardino
Steven has a account
President and CEO at Medical Research Collaborative, LLC
Tampa/St. Petersburg, Florida Area
https://www.linkedin.com/in/steven-giardino-004877188?lipi=urn%3Ali%3Apage%3Ad_flagship3_profile_view_base_contact_details%3Bj5mmy72%2FSv6xff4F3AeirQ%3D%3D
Don't know who created the linked in profile.