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Send this to amarin/Covington vital they have this
HDG - Mori. Search Mitre posts mc1988 posts and tasty posts - all the good stuff on Mori in these.
Alm
Mori - it was me who asked Hamoa to do the same job on Mori - pull together Hamoa please all the earlier posts and crest on detailed document as you did with the Japanese’s study were several brilliant posts on Mori and also the professor from Washington did an amazing statistical analysis - all showing just how wrong DU was as to her observations in her judgement those posts were within three or four days of the judgement
Mori is vital in this appeal because it demonstrates one of a number of serious factual errors by Du
Alm
Send this post to amarin/ Covington
Alm
Hamoa - also please send this to amarin/ Covington - vital
Alm
Can you please apply your brilliant mind and unstinting effort to the Mori aspect of her ruling also ? ...both require the same level of scrutiny - both represent serious errors of fact by Du and are vital aspects of the appeal - as you so clearly set here as to Kur study - let’s do the same job as Mori - we have a double edged sword here in this appeal
Please send this to amarin/ Covington
Exceptional work -thank you
Alm
BO crazy talk
If Amarin is to be BO it will not be until after appeal-why?
1covid will have knocked V’s sales trajectory in 2020-the patent case loss will have no possible impact until well after appeal
2-if-amarin wins it will be back on track as to sales - maybe a lost year in terms of sales pushing through 2020-but would have been dented by covid anyway
3 if win appeal BO by pharma will be valued at perhaps one years less sales but hopefully markets generally will be recovering from covid by then
4 if loss - then can get what they can from EU and Row and whatever may be fought over with generics as to USA
5whats the upside benefit of selling now - monkey nuts -as to BO value of USA- value EU and Row remain essentially same now and in April 2021
6 what’s the upside selling after appeal win -huge
7 what are chances of win -way more than 50 -50-so why risk huge possible benefit from win against a money nut sale now
8 the company will not be bought out until post appeal - Jt would not be looking after shareholders interests by doing so - someone can try do the comparative guess value maths on this but it’s a no brainer
9 amararin can easily survive this year and next - they will cut costs / sales force / advertising- money poorly spent in a covid affected year
10 they can afford to sit and wait and deliver on appeal
11 longs who sit through to successful appeal will be very happy 6 dollars now - what price post an appeal win
12 upside is great - downside is low
Alm
Excellent work ... can you do the same as to Mori?
Alm
The Kura issue
This must be sent to Elizabeth at amarin
This must be pursed in appeal
It is vital along with Mori error as to Du have reached the wrong decision as to obviousness
Alm
Kura issue
Send this to Elizabeth at Amarin
Vital they take this up in appeal
Alm
Vascepa reduces systemic inflammation - covid 19 patients should all be getting it and fast ... Alm
JL covid-Use of Vascepa you have long directed us to the problems of systemic inflammation and the benefit of Vascepa - you gave to your plastic surgery patients - surely possible benefit of covid 19 patients being put straight on Vascepa - that would help patients and help Amarin - thoughts
Alm
DU RESIGNS-in the face of all the error in her judgements-She will - this is another monumental factual error which she adopts - SEND to Amarin -no judge can be allowed to continue to sit when so many judicial errors with such devastating impact - billions lost -through her failed judgement - we have to attack her continued appointment as a judge - we have to strip every line down of her judgement and critically examine every aspect of it - Brilliant work here. And as to Mori And Kur -the ever growing erroneous findings need to be brought into the public domain - This was no boundary dispute - this was litigation where the cost of judicial error was gigantic
why does not the board pay for the Harvard Professor to write a long and detailed opinion on the erroneous findings of fact and procedure - ??? what publicity that would attract - I will gladly pay my share - it would raise the share price hugely !!!!
Share price to recover - HOW??Du has made unprecedented and appalling errors of factual judgement on Mori and Kub - on which she based her finding of obviousness -the Appeal will reverse those factual errors- it can not do anything else -Du made astounding procedural errors as to the application of secondary considerations BUT the appeal will not need to address these because the factual errors corrected on appeal remove the finding of obviousness - a Detailed brief needs to be written setting out the errors as to Mori and Kub - (Hamoa please do this for all - others to assist as to study/ stats) send it to Amarin.-So that they have the clear facts on these two studies and statistical explanation of the same and the procedural error Title-“HOW Judge Du judicially erred as to fact and procedure”-
Amarin must demand an expedited appeal on the basis of the Indisputable clarity of factual judicial error and judicial procedural error and the consequent appalling and ongoing damage to the company its shareholders and employees
Send it to Michael Yew at Jeffries - he will get his Harvard professor on air again lets get these things clearly spelt out to the investing world
Send it to Judge Du
Considering these new dramatic devastating findings -this will destroy Du as to her reputation and credibility as a judge - she should and must resign from the judiciary - given the astonishing level of factual and procedural error and the consequent devastation she has caused - she does not deserve the confidence of the American people -at a stroke DU’s erroneous judgement wiped many billions of dollars in value from the company - she destroyed investors -she put in peril a thousand jobs -the American investing public and institutions must demand her resignation - How can she remain in office ??
She will actually recognise herself the enormous gravity of her errors and it’s consequences - she will resign
Watch the share price recover when she resigns
Just because she is a judge this does not absolve her of the consequences of her actions
Alm
This is a vital and fatal error
As is the error in Mori
Send this post to Covington. Amarin’s lawyers
Brilliant work
Alm
HD - brilliant finding as per your post that Kurcbayashi WAS considered by the POSA as to the Amarin patent application - Judge Du is thus wrong in her reference to this NOT having been considered by the POSA!!!!
R Mitra has already done a brilliant job on destroying the judges findings on the Mori trial study- she has made a serious error as to fact on Mori which the appeal court can examine and rule against her upon - now what we need now is for R Mitra if he would be so generous is to do an analysis of Kurcbayashi - you express that the POSA found it was statistically significant - the judge has asserted this study was evidence of obviousness - although wrongly suggesting the POSA had not considered it - it would be a double whammy if in fact on a proper statistical examination this study was not statistically significant - neither Mori - which it now can not be -or Kurcbaysahi -could then be considered factually correct and the judge would have made serious error on both these study assessments by her - can posters who can contact. R Mitra beg him to undertake this exercise
This is crucial to winning the appeal on the test of obviousness - we are home on Mori - Let’s see if the same applies on K.
I am a trial lawyer in uk - this is how you win appeals - chew up and destroy the basis on which you lost at first instance
Why there was no statistical expert report / statistical evidence called on these studies is incredible - they should have been blown out of the water !!!!
Alm
JL - I address to you -but also others I hope will consider
Mori - great weight was placed on this “trial” by judge du
Has amarin undertaken a critical examination of Mori?
See walatane post 25904
He refers to table of results and “the high impact of LDL levels in DHA group v. The EPA group -that is in DU’s expressed reasonings
1-what reliance can be placed upon this result in 2008?
2-has anyone checked the calculations on which these findings are based from the small male only much less than 500trig group for a 6 week trial as this was?
3-do the specific results of any within this group skew the finding numbers
4-is the outcome as to numbers remarkable?asignificant result?
5-can a remarkable or significant result actually be obtained over only a six week trial period?
6-what do the statistic results of other trials on EPA show for the first 6 weeks -marine? Reduce-it? At 6weeks where were the figures moving to on these other trials?
7- can the Mori results be statistically extrapolated to give a predictive outcome if it had run for 6 years and thus a comparative to reduce it out come be obtained - what does that show?
8 at what point in time we’re similar remarkable / significant indications arising in other trials - 6 weeks ?1yr?2yrs?when exactly?
I am not a Dr or a statistician - I am a trial lawyer in uk - if I was pushing this appeal I would want suitable experts to take apart everything on the Mori trial and other trials the judge used to back her position
I would want to destroy the credibility (if there be any) of these trials to show that could not be relied upon
Does this stir any thoughts from you / other board members with relevant experience ?
Alm
Have people read the full Mori 2000 report - ?not just the summary- it was a trial - if it can be described that way which lasted only 6 weeks !!!!!!! In 2000 -I think the drs on the board - and those with patent law experience Jesse in particular need to read every last detail to see how this report can be attacked for its extreme limitations - In 2000 a six week trial on less than 60 men only - is now being evoked by the judge to demonstrate the patents fail as obvious -come on guys this is bullshit
Can the full and detailed records of that trial be considered in the most minute detail
A trial I believe in Perth Australia but reported in an American journal
I don’t have any medical expertise but this needs a medical and legal forensic onslaught being applied to it
Jessie - tear it to its worthless shreds
Let’s get new evidence into the equation as to just how wrong this judge has been -The link from post 259012 johnking29 allows you to read the summary but by pressing on the links therein you can access a far more detailed account of the trial -But behind that there must be even more records that can be assessed
Let’s fight .... let’s attack ... we have a problem ... let’s work the problem -if you Americans can get Apollo11 back from disaster you can collectively win this damned appeal
Amarin needs all the help it can get .... this appeal can be won
Ask yourselves what would be the impact on the value of this company if this appeal is won ??
HG
Why would Amarin settle if the Judge grants inducement infringement ?.... they would carry on with the trial
Alm
JL ..you are Amarin...you are the spirit of Amarin
Take a little time out ...it’s been a long year
Alm
TTE. A very noble SElvish sentiment expressed for the benefit of your fellow board members But hell there is no way we want a bidding war leading to a buy out - t
Think what’s worse -getting 100 dollars a share or never being able to read TTE posts when the board closes down because Amarin doesn’t exist any more-
No way !!!
Time people on this board got their priorities right -TTE must post forever
From the distance of the UK it is shocking yet at the same time vaguely amusing to witness the incredibly pathetic and obviously transparent efforts of GS and crew to push the SP down -is that best GS can come out with ? Seriously?
The reality of the value of Amarin will within 6 /12 months be reflected both in sales and of no doubt a significant value buy offer for the company
Longs-Give your shares away now at 16 bucks??
You’re having a larf!! Try me at 60 dollars -I might be interested
We should all sit back now and enjoy the fruits of our determination loyalty and labour
Alm
Sam - I rarely post - a longtime share holder since way before trial outcome hold 100,000 shares - thank you for all your time and effort-and to many other dedicated and informed posters. Greatly appreciated I can assure you.Buy out is an expectation of many in due course - what I consider would give confidence is a simplistic monthly spreadsheet tracking sales- your weekly -but taking monthly figures/how these would be if annualised / a stab at monthly and annualised sales values/and then a stab at share price assessed to sales/and thus market cap
From this we could see monthly growth and trends and assess reasonable expectations of these things
I don’t know if there is anyone out there who could set such up applying logical methodology-such would give us comfort in difficult times to see these things developing and on an informed basis
I suspect such might be difficult to create but it would also set a template for future growth expectations whilst we GIA as we do now. And may give a basis for reasonable BO expectations-GIA is a long slow path which we have been following and may continue to follow ...for some time to come ..having a realistic handle on where we are at and where we might be 1 year 2 years 3 years from now- would be a great support for presently rather battered longs
Alm
You are absolutely right...off label of course ...
surely amarin will run a short small trial to cover this and get a further expansion of the label?any other way to achieve this ? It should be something amarin have already considered/ addressed unless they just hope to get at adcom a very wide non statin linked label ?
Such would dramatically expand the market for V
Raf - the position as to the FDA is beyond comprehension - and indeed may I suggest a rather more formalised version of what you set out should be sent to Woodcock to ask how the FDA can possibly justify such an unaccountable regime -particularly given her recent comments about the development of drugs in the USA- I am from England - no public body here could operate on such a basis - their processes or obvious lack of an established and formalised one would be the subject of Judicial Review. The absurdity is that the FDA add hugely to both cost and delay in the drug approval process which directly conflict with Woodcocks recent comments - you USA citizens should demand that the FDA regime is overhauled- they need look only in the mirror !!
Alm
James- again not a chance in hell of that happening-there are no logical scientific or safety reason why approval should not be granted-conversely the evidence supporting approval is simply overwhelming -there is now an avalanche of evidence disseminating amongst the medical profession as to why they must prescribe V-labelling is the last obstacle - once the label is expanded Drs will have to prescribe or else they will breach their duty of care -they will face legal action for failure to prescribe
It is inevitable that the share price will increase on label approval as sales continue to rise and as takeover speculation develops - label approval will eliminate the principle obstacle to BO
James .... 9-2 ???? not a chance in hell
Unanimous - the only voting outcome possible
Not one of these AdCom members will want to look like a pariah voting against label expansion of the most important cardiovascular drug to be developed in 50 years which save lives and prevent severe illness from cardio vascular events for millions of people
There have been many posts about the impact of delay in approval and the FDA through delay seriously adversely affecting the health and lives of so many Americans - Americans will die as a result every single day. I am not a statistician but can not a calculation be made of what each day of delay costs - in lives lost. heart attacks /strokes /of all the other events that V will prevent.. can that not be augmented by a daily financial cost calculation to health care costs/lost income and so forth - daily increasing numbers posted on this board on all boards -in the press -your state and government representatives need to confront the daily costs
A daily chart ... each day FDA delay costs x lives- a daily countdown of death / illness / financial loss
Can not the the American medical profession be called upon to clamour to demand to insist that delay with such a crucial drug -a safe drug can not be tolerated -by those who to have to treat the sick and the dying
Is not this delay a national scandal which can not be tolerated
I live in the UK - I always thought Americans stood up for Americans fought for Americans never gave up for Americans
You don’t need to take the FDA to court ....you need to shame them - this is a national disgrace for the USA
Mellowmoods brilliant post -way too many - even some of the old stalwarts on this board- loose sight of the overwhelming science logic and reason as to why V will succeed -simply put -it works is safe and cost effective. There will be those whose businesses are affected who do not want it to succeed.Amarin must concentrate the resources of a small company on getting approval-adcom is now the priority because there will be one. They can not sue the world.Costly long running distracting litigation is not their priority now.
Amarin has to GIA unless there is BO-such is not an easy course -many obstacles and costs to overcome JT will not get everything right but by God he has got us this far and I for one would have him run this show above all else ..who can do a better job? In truth he has done an incredible job - he could skip off to another company with his pockets loaded and get paid many times his current taken benefit -he has not sold out his stash of shares
We longs .... are just that -LONG -the aim is to get us longs to 50ps-100ps??_but long requires time patience faith and belief- V is an astonishing drug - never forget that
Panic and lunacy will persuade you to sell your shares- for a pittance
All this boards negativity works just about as well as MRC effort as a share price downward driver
Many leaders on this board are looked up to for their knowledge experience science determination and faith -
If anyone want to sell up now be prepared to kiss goodbye the best opportunity of a lifetime - I will sell my 100000 shares when they are several times their current value ... I owe everything to the leading lights on this board ....but can they now ask themselves - are they losing sight of what really matters ???are you still leading your flock by shining your vast knowledge experience and logic?
Mellow wood just shone through with the brilliance of his examination off what really matters ... we owe him a great debt
Let us hope V will provide great benefits to all those who suffer from prostate difficulties-so many will owe a great debt to you for championing this wonderful drug -your brothers passing is a very sad loss to you and your family
They can only sell Europe if the BOD believe they will not get bought out. If they sell Europe now /when approved they are going to drastically restrict buy out potential and price. do we not loose sight of fundamentals in this reaction to day to day SP- ? an incredible drug and incredible market -an incredible future - either GIA....but expect that will always have ups and downs but nonetheless from here and soon an upward path-ultimate SP 50/75/100/150?? or BO for a far greater market cap than now - 20B/30B/50B more ?
One or other will happen - this drug can not and will not fail
The company holding it - Amarin or BP will do very very well - so will shareholders
We have been on a long road ... it will be a while longer yet but faith and patience will be rewarded
Dan
A simply brilliant job ... may I suggest that you send this to Amarin... they may want to use this letter as a nutshell summary of ICERs assessment of Vascepa
It represents an incredibly useful marketing aid
Allan
The past two days have been disappointing-it is a simple fact that the share price has gone down because there have been more sellers of shares these past two days than buyers. To state the obvious to achieve an increase in share price there needs be more who want to buy the share than those who want to sell.
This is a well run company with a drug that indisputably is the most significant new drug development in decades and will be prescribed to many millions and will save countless lives for which we all can be grateful. We do not need a discussion about the science or the results of the trial-such is now absolutely clear and beyond any doubt. Doubt expressed over science and the trial simply equals FUD.
Institutional buyers are not influenced by FUD (only fools would sell in response to FUD)nor are other well informed investors-for example Baker Bros.
Such institutional and intelligent investor buyers will recognise the vast future earnings capability of Amarin and the fact that Amarin is inevitably a BO target even though it may wish to GIA.The company is thus a great share investment. The increase in sales of the drug over time will not go unnoticed nor the good management of the business in its many facets thus far and in the future. For those who are long term investors we must take a long term view - this up down really is irrelevant-(it would only be relevant if you sell) in the long term this share will undoubtedly increase in value many times over-again simply put there will be more buyers over time who want to invest in this company than sellers of the shares. Patience is a virtue - we have exercised it long enough we can and will continue to do so. I have avidly read this board for years- can we resolve to concentrate on the positive developments of this business and ignore all the complete bollocks of FUD that has littered these pages of late?- neither read it nor respond to it- a waste of our very valuable time and intellect.
My second post....I have never felt more confident in the successful outcome which will be revealed tomorrow-I am not a Dr or a statistician but the logic of the outcome is inescapable ... as a cousin from England to the Band of Brothers a simple message ... stay strong and believe in what you know is right - this stock will ascend
I have been a shareholder for several years-bought when they were 6 dollars and stuck with the share through all the trials tribulations and lows- I bought further shares right up to two weeks before the headline results- now holding just short of 100,000 shares -Why?- In all honesty because of the incredible depth of information provided by a number of contributors to this board whose sheer brilliance is beyond question. I am forever in your debt. I am from the UK- but have been sorely tempted to jump on a plane to Vegas and the AHA this Saturday to share the moment albeit that I have been a silent observer from afar.Everyone who has held shares over these difficult times deserves their success for their perseverance and dogged determination -I am certain that AHA will be spectacular in its outcome.
To JL, in particular, can I express my immense gratitude for his knowledge, vision, wisdom and immensely generous guidance so freely given over many years. I hope he returns to lead his fold!!