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RAF: Thank you for the update! Very much appreciated!
NICE JOB! Thank you for the Follow-up!!!
BIO: "J" on the Amarin Yahoo Board (6) hours ago...
BIO: Not sure if this was posted nor do I know it to be true yet it doesn't get much better than this assuming it is:
Scripts Ending 1/10 - Probably already Posted:
Script Data - w/e 1/10/20 | AMRN Message Board Posts
https://www.investorvillage.com/smbd.asp?mb=2294&mn=6463&pt=msg&mid=20185765
Excellent Trial Update by Jefferies - Discusses Infringement and Obviousness:
Go to 22:05 thru 25:30 for excellent insight thru 1/16 of the Trial...
https://players.brightcove.net/pages/v1/index.html?accountId=4090876629001&playerId=M0SQPuFae&videoId=6124162652001&autoplay=true
Vascepa - Additional Benefits...
Today's NY Times:
Fish Oil Supplements Tied to Sperm Health
https://www.nytimes.com/2020/01/17/well/live/fish-oil-supplements-tied-to-sperm-health.html
Whoever wrote this concern brings up a good point!
If we know the PPS will not 'jump' on a win, why carry it thru the risk great or small? Knowing this stock, it's going to drop on positive news!
The chances of a "Buyout" on a Win (at the same time) is not going to happen!
What's the bigger win??? 'Selling and buying back on a win' or 'risking everything for a no-gain win'?
This 'win' is NOT where the money is! Long-term.great sales then a buy-out is where it is!
If we lose, it will be a sickening day!
Thoughts??
Long Since 2012!
Jeffries Day 3 Trial Summary:
JEFF day 3 - Trial Remains Heated as Expert Testimony Cont's...AMRN in Good Position | AMRN Message Board Posts
https://www.investorvillage.com/smbd.asp?mb=2294&mn=6440&pt=msg&mid=20180018
And it is nice to hear a laymen's full day summary without all of the Legalese...
Reading the bullet points from the Court witness (layman) is interesting to me, someone who is not so tuned into the Legal Jargon in the daily Court Summary...
James Murphy: There are (2) people... A guy who goes there on his Lunch-Break and someone else posting the link you see below...
The link below is a much more detailed essence of what is happening...
I am hoping to post these updates as I find them which should be daily...
I posted this one twice today yet did not seem to get any comments and/or feedback at all from anyone on this board which quite frankly surprised me...
https://www.investorvillage.com/smbd.asp?mb=2294&mn=6420&pt=msg&mid=20176390
AMARIN DAY #2 TRIAL REVIEW (BUMP):
https://www.investorvillage.com/smbd.asp?mb=2294&mn=6420&pt=msg&mid=20176390
Jeff on AMRN trial day 2 | AMRN Message Board Posts
https://www.investorvillage.com/smbd.asp?mb=2294&mn=6420&pt=msg&mid=20176390
Herper + Feurerstein Article from this morning: Can anyone open and post this in full? Just (sort-of) curious as to their comments meaning positive, negative, or neutral...
https://www.statnews.com/2019/11/14/fda-advisory-panel-reviewing-amarin-fish-oil-drug/
Which is 30 minute from now...
Exactly...
HAMOA: Excellent summary of what I believe everyone on this board is trying to say!
THANK YOU!
HDGabor: Can you comment or shoot some feedback on a recent post #239485? Would love to get your take on this position relative to the upcoming Trial..
Here it is below well authored by Ortakoy17:
Inducement: The Sanofi decision is as close to parallel with respect to facts and posture as I can find related to AMRN's inducement claim, and it serves as guiding precedent. In fact, the Court, on its own, cited and relied on Sanofi in denying Defendants' motion for summary judgment as to the inducement claim on October 28, 2019. In effect, that sets a benchmark for Defendants at trial. Notably, Defendants' brief fails to address the issues highlighted by the Court in denying summary judgment, or the Sanofi case generally. The case citation is Sanofi v. Glenmark Pharmaceuticals, 204 F. Supp. 3d 665 (D. Del. 2016). It is available online if you simply google the case citation.
Sanofi involved a bench trial and a claim for infringement directed to treatment of AF for at least 12 months. Sanofi's drug was indicated for AF but their patent was for AF plus risk factors - and generics argued that physicians will prescribe it only to patients without risk factors. Similar to our facts, its clinical study was run with patients who only had risk factors. The therapy was ultimately indicated for use for chronic disorders, for which clinicians intended administration indefinitely; the label did not limit the duration of treatment; and the label reported the length of the clinical trial.
All of these factors are present here, and, importantly, cited by the Court in denying Defendants' Motion for Summary Judgment (see page 10 of denial). The Sanofi Court concluded that Defendants' labels would encourage SOME physicians to prescribe the drug to patients with risk factors, and will thus inevitably lead to infringing uses. The Court expressly stated: "[e]ven if [Defendant] were correct that the [language in the label] may be applied to other dosing regimens, the language ... would inevitably lead some consumers to practice the claimed method." The Sanofi decision clearly emphasizes the legal standard, i.e., that the proposed label would inevitably lead SOME physicians to infringe.
The similarities are evident. Defendants' proposed labels speak for themselves, as identical to our label that instructs physicians to prescribe the medicine indefinitely as treatment for a chronic condition without the expectation of effect on certain lipids. Similarly, the proposed labels instruct that treatment effects can be achieved without concomitant lipid altering therapy. Our patents cover these points and Defendants cannot get around this without inducing infringement. This was sufficient for the Sanofi Court to conclude that the proposed label there would encourage some physicians prescribe the drug to patients with risk factors, and inevitably lead to infringing uses. The burden of proof here is preponderance of the evidence (51%), and Sanofi gives us the framework for understanding how to satisfy that burden.
Hypertriglyceridemia is a chronic condition that requires long-term therapy. Bolstering this, this Court has already found the argument to be "intuitively persuasive," in that "chronic conditions require indefinite treatment." AMRN also supports this with expert testimony. I also do not see this proposition expressly denied (rather carved out) by any of Defendants’ experts in their brief.
Similar to the proposed label and instructions in Sanofi, Defendants' prescribing information literally encourages treatment for at least 12 weeks (see Table 2 of Clinical Studies). The entirety of the label was used in Sanofi as it will be here, thereby allowing references to the clinical study section and trial which will undoubtedly favor inducement. The label expressly instructs patients "not to stop taking the medication" without talking to their doctor. With this backdrop, the Sanofi Court held: "I find that Sanofi has proven by a preponderance of the evidence that Defendants knew that their proposed labels "would inevitably lead some [physicians] to [infringe]."
HDGabor: Can you comment or shoot some feedback on a recent post #239485? Would love to get your take on this position relative to the upcoming Trial..
Here it is below well authored by Ortakoy17:
Inducement: The Sanofi decision is as close to parallel with respect to facts and posture as I can find related to AMRN's inducement claim, and it serves as guiding precedent. In fact, the Court, on its own, cited and relied on Sanofi in denying Defendants' motion for summary judgment as to the inducement claim on October 28, 2019. In effect, that sets a benchmark for Defendants at trial. Notably, Defendants' brief fails to address the issues highlighted by the Court in denying summary judgment, or the Sanofi case generally. The case citation is Sanofi v. Glenmark Pharmaceuticals, 204 F. Supp. 3d 665 (D. Del. 2016). It is available online if you simply google the case citation.
Sanofi involved a bench trial and a claim for infringement directed to treatment of AF for at least 12 months. Sanofi's drug was indicated for AF but their patent was for AF plus risk factors - and generics argued that physicians will prescribe it only to patients without risk factors. Similar to our facts, its clinical study was run with patients who only had risk factors. The therapy was ultimately indicated for use for chronic disorders, for which clinicians intended administration indefinitely; the label did not limit the duration of treatment; and the label reported the length of the clinical trial.
All of these factors are present here, and, importantly, cited by the Court in denying Defendants' Motion for Summary Judgment (see page 10 of denial). The Sanofi Court concluded that Defendants' labels would encourage SOME physicians to prescribe the drug to patients with risk factors, and will thus inevitably lead to infringing uses. The Court expressly stated: "[e]ven if [Defendant] were correct that the [language in the label] may be applied to other dosing regimens, the language ... would inevitably lead some consumers to practice the claimed method." The Sanofi decision clearly emphasizes the legal standard, i.e., that the proposed label would inevitably lead SOME physicians to infringe.
The similarities are evident. Defendants' proposed labels speak for themselves, as identical to our label that instructs physicians to prescribe the medicine indefinitely as treatment for a chronic condition without the expectation of effect on certain lipids. Similarly, the proposed labels instruct that treatment effects can be achieved without concomitant lipid altering therapy. Our patents cover these points and Defendants cannot get around this without inducing infringement. This was sufficient for the Sanofi Court to conclude that the proposed label there would encourage some physicians prescribe the drug to patients with risk factors, and inevitably lead to infringing uses. The burden of proof here is preponderance of the evidence (51%), and Sanofi gives us the framework for understanding how to satisfy that burden.
Hypertriglyceridemia is a chronic condition that requires long-term therapy. Bolstering this, this Court has already found the argument to be "intuitively persuasive," in that "chronic conditions require indefinite treatment." AMRN also supports this with expert testimony. I also do not see this proposition expressly denied (rather carved out) by any of Defendants’ experts in their brief.
Similar to the proposed label and instructions in Sanofi, Defendants' prescribing information literally encourages treatment for at least 12 weeks (see Table 2 of Clinical Studies). The entirety of the label was used in Sanofi as it will be here, thereby allowing references to the clinical study section and trial which will undoubtedly favor inducement. The label expressly instructs patients "not to stop taking the medication" without talking to their doctor. With this backdrop, the Sanofi Court held: "I find that Sanofi has proven by a preponderance of the evidence that Defendants knew that their proposed labels "would inevitably lead some [physicians] to [infringe]."
Ortakoy17: Excellent Write Up! Thanks for Posting!!!
Can you post the call in number and any code so I can jump on?
Law Suit thoughts:
1. Amarin has no interest in settling. They know they will just get Sued
over and over. I hate this analogy yet a good example is how Michael
Jackson settled then everyone else came out of the woodwork... It
won't stop if they keep settling (not that they may not have to -
read on...)
2. Amarin may be motivated to settle depending on how the next 2 weeks
work in or not in their favor... Every Pre-trial move by the Judge
is huge.
3. Dr Reddy is by NO MEANS going after the Marine Patents... The Judge
is not dumb enough to think this is why they are there. That brings
in the thought they they plan to try to sell the drug off label in
effect supporting the Inducement argument.
4. How important are the Marine patents on the other hand? Big enough for
Amarin to sue the FDA to be able to sell Vascepa for the same purpose!
5. On one hand she knows what Dr Reddy is up to yet on the other hand
she can't turn her back on "Amarin's own position + inferred value"
of the Marine Patents...
6. I see it as a coin toss if she will let Reduce It in...
7. If I were her: Why not play it straight and not allow Reduce It,
lean in favor of giving up the Marine Patents (all Pre-Trial), then
we will see Amarin settle...
8. Other position she could take: Allow Reduce It knowing that is
really what Dr Reddy wants (to cut Dr Reddy's legs off at the
knees), then find in favor of Amarin. **My concern here is we will
see an Appeal knowing she basically ignored the implied value of
the Marine patents even though we ALL know this is NOT what Dr Reddy
wants...
This will then create another chance for Amarin to settle...
Philadelphia Inquirer Article from today: Surprised to see that the Cardiologists call Vascepa "expensive"...
A Philadelphia cardiologist lists the top 10 heart health findings of 2019
https://www.inquirer.com/health/expert-opinions/heart-health-impossible-burger-stents--20191231.html
I agree with you...
Yet I keep reading on this Board where people believe "a Settlement is in Everyone's Best Interest"...
IMO: Only if the defendant publicly is forced to say:
"We do not believe we can beat these Patents" as part of the settlement!
There is a home-run...
My gut tells me Amarin has no interest in settling...
I am swayed by JT's comment in that interview when asked "Will you Settle or Fight?"...
He initially dodged the question then ended with: "We are going to fight" and he constantly makes the comment regarding "Strong Patents".
Bio also puts up a great argument regarding what the OB will include soon...
So why settle?
Amarin needs until March at least to get things up and running anyway so it is not like it is going to be "lost time" waiting for a positive decision that Amarin (and everyone on this board) believes they are owed.
Otherwise what do you do: Keep fighting Patent Infringement Suits?
It is absolutely devastating to everyone (Company, Investors, and possible Buyers of the Company) to have to keep settling and fighting over and over...
So why settle?
BIO:
What are your thoughts on Amarin intentionally running the Case in Full 100% until the end "To Set an Example for other Generics" so they think twice about future challenges their Patents?
They are attempting infringement because #1: They can win a Settlement or #2: Amarin has not won a Patent Lawsuit yet...
Amarin is suing... When they asked JT in a recent TV interview (I think it was MSNBC) if he planned to Settle or Fight, his reply was eventually: "We are going to fight"...
In short: Why settle? It will just invoke other idiots to keep doing the same thing just as these guys are doing...
Win a case like this and it basically shuts the door on many of the Generics arguments...
Settle and the next Generic thinks they can do the same thing and win a bunch of cash in a settlement or possibly get a weak Judge who sides with them...
Your thoughts?
Trial/Settlement Question: Is a Settlement 100% off the table and all parties are going to trial?
Effect of Icosapent Ethyl on Progression of Coronary Atherosclerosis in Patients With Elevated Triglycerides (200-499mg/dl) on Statin Therapy (EVAPORATE Study)
https://www.abstractsonline.com/pp8/#!/7891/presentation/35090
Jesse WebCast Info: Here it is...
November 14, 2019, Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) - Webcast Information The Center for Drug Evaluation and Research (CDER) plans to provide a free of charge, live webcast of the November 14, 2019, meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. Please note that the webcast will not display until the meeting begins at approximately 8:00 a.m. EST on November 14, 2019. While CDER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to reestablish the transmission as soon as possible. CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available. Webcasts of advisory committee meetings provided by CDER have limited capacity. Once capacity of the webcast is reached, no additional individuals will have access to the webcast unless others have exited the webcast. If an individual signs off from the webcast, CDER cannot guarantee that this person will be able to sign back on if capacity has been reached. The meeting webcast can be accessed at the following web address: https://collaboration.fda.gov/emdacnov19/ Note: At the access page, please sign in as a guest. No password is required. General Information: The webcast will be broadcast using Adobe Connect. You can check to determine if your computer has the correct plug-ins in order to view the webcast by accessing the following web site: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm To access a quick overview summary of the Adobe Connect software visit: http://www.adobe.com/go/connectpro_overview For further information regarding webcasts and archived webcasts, and for contact information of staff available to assist with questions, please visit the “Public Meetings at the FDA White Oak Campus” website at: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInform ation/ucm241740.htm
Someone Posted a Link I believe Monday or Tuesday that appeared to be a free first come first served until full...
Jesse: AdCom Live: Try this link... Half way down...
FDALive - The World's Leading Source for FDA Broadcasting
https://www.fdalive.com/
I hope we all wake-up one morning soon and read this same headline from today about Amarin Shorts:
"Short sellers betting against Tesla lose more than $1 billion in single day as stock surges"...
It's a shame they don't notate the changes. I am grateful for the feedback! Trust me when I tell you that!
Let's not miss the point...
Revised in April 2019 and Updated in September of 2019...
The FDA must have been quite bored this year to casually think about the effects of Mineral Oil and Absorption...
I hear you yet to read "...based on recent studies..." (or however they phrased it) and then posting concerns and updating artickes regarding absorption implies to me that they are suddenly re-thinking MO despite what they've allowed the last many years...
I am just hoping the RI process and its' final results will show a nominal effect like Dr Bhatt supports. They and the AdCom board need to buy into as well (as we all know at this point.)
Just to read that they are rethinking MO in late 2019 concerns me especially going into AdCom...
We will see!
Thank you for the follow-up!
The timing is very suspect though. We can't (seem to) get them to ever act yet they "suddenly" come out with this new discovery and have time to focus on Mineral Oil? Hoping you are right and that our case is 'minuscule absorption' and not worth looking into further (as Dr Bhatt has said.)
Let's put it this way: They are thinking about it and I am not liking it.
Bio + Jesse: Maybe I missed it yet do either of you find it any bit unusual that the FDA is suddenly interested in "lack of absorption" due to "injesting Mineral Oil at mealtime"? To suddenly note that "recent studies imply a problem with 'absorption ability' of anything due to Mineral Oil" seems quite suspect right now. Cannot imagine this is not going to be a major point by the FDA @ AdCom... Your thoughts?
(Long and Following both of you Since 2011...)
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=201.302
Always Appreciate your feedback! Thank you!
Isn't the contention that Mineral Oil possibly BLOCKS the absorption of Statins?