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FDA Rules for 'Authorized Generic' (AG) updated recently:
https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/fda-list-authorized-generic-drugs
sleven@ This question in not for me - I'm an absolute Lay Person in Law :)
Hope Marjac or Eight might be around - they will be able to answer your question !
HK@ You just made my day and Christmas - Thanks :)
Best of luck !
Jasbg
To the AMRN iHub Board - here is my Thanks Giving Wish - for Amarin and all of us Longs who 'many for now' have lost fortunes - after Marts 2020 - loss in Nevada trial.
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And have to stress that this is wishful thinking from following this board for a couple of years rather closely - and I hope that the 2 people I mention will not be offended by my thoughts/proposals.
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I think that we are many here that feel - that Amarin (after Hikma entering market with GV 3 weeks ago) is at a critical point - in where to go from here.
Two people from this board - would in my opinion be 'The right medicine to give Amarin a chance - to 'shake up' things for the Company - to chose the right direction for the future - for shareholders - and for CDV patients WW.
One of them Hindu Kush - (an absolute genius in the Scientific and medical field of bio world) I have already contacted him here directly - on a open Job (to me) made for him at Amarin's.
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The other poster I would love to 'put new thoughts and plans' into the mind of Amarin BOD is poster Will Lar - who has a lot of experience in doing business in Europe.
Will has the right attitude against 'Amarin needing a broader pipeline' - need to OWN production facilities (independence) etc. From the forum here - Will is very well argued - my feeling - I would love this guy being part if Amarin team for planning the future.
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Again have to stress - these is my personal ideas of - what could Move Things at Amarin's.
Haven't confronted either posters with the Ideas directly - but hope that they will not be offended - by me suggesting them to be part of my thoughts - of Saving Amarin - for the CDV patients of the World :)
Jasbg
BB@ Problem here is 'time'. Lawsuit's takes a lot of 'time' - and in the meantime Generics - could easily have stolen a very big part of Vascepa market in USA (a lot more than 10% - more like eg. 50% before any court case).
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Generics on Infringement: "Not our fault that States and Insurances 'demands' Generics if available" - "We are just a company that sell's Drugs - and tries to fill demands" - Label ? "What label is that you are talking about" ?
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This fight has entered a New Dimension.
Amarin shall pursue the small chance of taking patent case to Supreme Court !
But at the same time 'plan on taking the fight 'to the Market in US'- and 'that we can already' in 3 weeks see' means Going AG - 'you have to be generic in US today - as soon 'other generics' have entered the market - to stand a chance. How long before Dr. Reddy - Teva - Apotex enters also ?
After 3 weeks it is already obvious (and Hikma and Reddy knew that from years of experience - with lots and lofts of drugs) - as soon as generic available - this will very fast overtake Brand.
Maybe the biggest of BP would be able to Protect Brand value to some extend - as it looks right now for Amarin in US - there is nothing to stop Generics (they will find the raw materials they need - these are big and powerful companies - with influence and means).
Jasbg
rose@ I cant speak for the whole of Europe - but your right that the courts - are not in anyway as 'politically engaged' as in USA.
Most people se the courts as 'what they should be' - non political. Mostly concerned around criminals cases - and disputes generally between companies internally and/or private citizen's.
Jasbg
tuca@ Thanks again. Not nice reading - but the truth is the truth.
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All the way back to where Amarin downfall began - I newer think that Amarin fully understood what they were up against in the patent case.
The Lawyers at Hilma (591 drugs) - and Dr. Reddy (190 drugs) do these patent cases all the time - they Are Specialists - in every bit of Litigation - and Using whatever means needed to win.
Surely the fraud used to win over Amarin - will not be the first time these Lawyers have 'bend the truth' to win - nor will it be the last.
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As it looks now JT - it do look that the expensive DTC's and reps are only helping Hikma - who gains as Brand Amarin falls back. This development cant go on for long - before some change in policy has to happen at Amarin.
HK@ Don't know where you live in US.
But if you will be aloud by your family - 'apply for the job HK' - and go save the Company for us' (and yourself).
You're the man who can DO IT :)
Jasbg
PS. But do not loose your family over it. If family 'says no' rest of us have to live with the loss - and you shouldn't loose sleep over it :)
FFS@ Your welcome. I know that Tom use - mostly:
https://www.etxcapital.com/en/us - so this must be good for Day Trading - have not used it myself.
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I'm one of the loosing traders. In my case Amarin is the cause of my biggest loss till now - hope It will Change at some point :)
FFS@ The ever returning TA discussion - never ends :)
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I feel you are a serious guy about investment and trading - and this being Holliday in USA - I will send you a link - that touches TA - and a number of other know tools for Trading in the market:
Have to stress that this Guy is DayTrader - and DayTrader BIGTIME.
Being part of a locally in Denmark Famous Podcast (4 trading specialists competing every year who can make it the best (biggest profits) out of starting with 250 K danish KR.
In 2020 this guy managed to make the 0.250 million - into 80 million in June. Later lost 30 mill. now I think he is around 65 mill. Still absolutely vild :)
Listen to his philosophy regarding trading - gears up to 150 - not for 'small boys' :)
FFS@ iHub have problems handling the picture/chart you put in.
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Exiting analogy - about 'the edges of the river' - and investment. I will remember that - Thanks :)
Jasbg
HK@ Just to make sure you see this.
To me (not being a specialist in these matters) - it seems like this Job - 'is made for you' - and with all the demands i suppose salary will be good (maybe ½ in AMRN shares) :)
It would make me 'hold on to every share' - knowing you onboard at Amarins.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=159738593
Happy Thanks Giving :)
Jasbg
HK@ I think Amarin made a Job 'especially for You' :)
https://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=21628469-e451-428a-9cbf-7efe4cef17a8
The link do not connect directly - you have to go to link:
'Publications Process Lead'
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Jasbg
HK@ Said it before that Amarin should Hire You - to go 'Get' these generic thieves (one way or another) :)
Raf@ Some more specific information about Lisa Jiao - and relation to Amarin:
https://www.fiercepharma.com/special-report/lisa-jiao-amarin-2020-s-fiercest-women-life-sciences
Pharm@ Very impressive work. I especially like that you made it visual wherever possible.
JT/Amarin are so lucky to have people like you on their side - and ought to send you a nice Christmas present.
Jasbg
I will answer my own question from yesterday - about 'Legal process/progress'?
Nothing new on Supreme Court (I was stunned that it is only 20 days since En Banc Denial - feels like another life):
From the document linked below:
On November 4, 2020, Amarin’s rehearing and en banc petitions were denied, the court’s order is
available here. Amarin plans to file a writ of certiorari within 90 days of such denial to ask the United
States Supreme Court to hear Amarin’s appeal. Amarin intends to vigorously pursue this matter but
cannot predict the outcome.
Tal@ Thanks - good that someone knows how to read the numbers correct :)
mrmain@ Simple answer - Amarin stil does not make money!
Net income 2020= - 26M - and with the Generic now in Play - what will the future bring in US ?
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What i dont quite understand in MarketScreener is why Net Cash position is only 146 M (JT always talk about 600 M - in cash) hopefully it is an error:
https://www.marketscreener.com/quote/stock/AMARIN-CORPORATION-PLC-1658813/
https://www.marketscreener.com/quote/stock/AMARIN-CORPORATION-PLC-1658813/company/
rose@ Hope your 'not right' - even though you probably are'.
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After patent loss - 'The Thrill is Gone' - -
yud@ No One is talking 'official anything' - regarding this simple question - that I noticed.
There is a lot of people on this board that take Vascepa - which makes A Poster - have the thought to ask 'have many Vascepa users - have had Covid amongst posters here - nothing more to it.
Of course it could be seen as an indication' - that this would be interesting to look into - in a Real Study.
yod@ Why is it flawed to ask people if they had Covid ?
It is a completely legitimate and logic question. And especially in this forum where many are taking the drug.
cmm@ Very 'thought through input' - trying to help AMRN. But my feeling - about US market - after two decades of Investing - is not good right now - have to admit.
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BB a couple of days talking about HIKMA 'forced' to settle' - 2 days later we hear from Tucaman - that this completely new Generic in - 'TWO WEEKS' - stole +5% form Amarins prescriptions. And what would settling with HIKMA solve anyway.
To be honest I think that HIKMA is more worried about Reddy - Teva and Apotex - in the US marked - than Amarin.
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In the last two podcasts with JT I didn't hear one word about the legal process - of restoring lost Patents.
Not Good - as I see development right now 'A win in Court' - will be the only way for Amarin to Keep the US marked. As of today Generic's will Eats this Drug's potential - as they have done so very many times before.
This all in the New Political norm of USA - (all developers of DRUGS are Bandits - which it is legal and fair to Steal/Copy - for the good of the people ).
Relevant news for US Patient using medical Drugs.
Is this good for investors in Vascepa (AMRN). The way 2020 has been so far - probably not ?
Following an earlier than expected favorable court ruling
dmi@ Very informing and explaining why Dr. Bhatt has the weight that he has in this area.
He just 'spells out 'point for point' what is all about - even lay people like me - feels that this guy is 'thee Capacity' in this field !
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Thanks for sharing :)
Had a look ar Hikma - searching for Vascepa - 'Nothing' - no response - on search.
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So what product is Hikma actually selling as Vascepa Generic ?
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These Guys are 'Smart' - as they were in the Nevada patent case - using freaude to cheat the Judge. And surely after GSK/Teva case - new policy on informations (to minsk risk of infringement cases).
So Generis Vascepa on Hikma homepage is now called: 'Icosapent Ethyl Capsules'
https://www.hikma.com/newsroom/article-i4928-hikma-launches-icosapent-ethyl-capsules/
- No information on the FDA aloud only 60% active stuff in capsules.
wode@ It was ment as a joke - nothing more :)
It was a comment om post below - not on your response (my mistake):
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=159543335
wode@ After reading that - I thought 2 digits today :)
AMRN need all the good news it can get - and YES - Amazon is BIG - so it's fine :)
https://www.vascepa.com/benefits/
BB - Has to mean 'before' Marts ruling.
2020 is in every way a completely MAD year.
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Following US politics rather close for the last 5 years I already at this point sense 'that something is changing' after 'the steal in election'. Media is starting to realize 'the result of what they have been pushing'.
History has a way of surprising everybody - and I truly believe that 'deep in American soul' it is freedom and justice - that will in the end prevail.
This meaning that a Rule 60 Motion - from iHub Super Team - built entirely on Generic Fraude - just might be granted - and Judge Du - actually in the end Restore Faith in US Justice systems. Wouldn't that be great' for a New Years wish for 2021 :)
Jasbg
marjac@ These are 'trying times' for everybody (covid - politics - AMRN).
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Thanks marjac. I actually find that it is deserved that JT 'for once' get a bit of positive Feedback today - after his podcast (SP is actually rising).
Whatever you think of the AMRN CEO - the period after Marts ruling - what he's been called/had to read on different boards - can not have been much fun - for any serious person in a job with big responsibilities like his.
marjac@ WOW - I did get rather 'blown back in the chair there' - I would love to see you in court sometime :)
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Apologies for bringing up the 'could AMRN iHub Law work' - damage the overall chances' having Patents restored.
Good news it provoked you - to really 'ones and for all' clear up' why iHub Team - has every positive right/mening to pursue this case.
If anyone (a bit slow) like me didn't understand 'also the scientific power of the iHub Team' you spelled it out for everybody to understand.
Can only again' thank everybody on the team - and wish you every succes in battles to come.
ATB
Jasbg
Link to today's Video conference at AHA Scientific Sessions (if already brought here no harm done):
https://wsw.com/webcast/stifel27/amrn/2091104
LOts@ I't was not me who said it (I'm Lay person in Law).
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But it has been a Harsh treatment of Singer and Amarin in Appeal (rule 36) - just 'DENIED' - 'DENIED' - shareholder Amicus - En Banc.
You can't help question the 'chances' of the Code 60 Motion - not just also getting the 'DENIED' label from the Nevada Court - especially coming from shareholders. But it seems nobody wants to put percentage on chances of succes (motion accepted).
eight@ Thanks for answer.
1. Would you dare - to put odds on chances of a succes in a rule 60 motion - from shareholders ?
2. As I understand it - Amarin is trying to have the Nevada ruling being brought/accepted at Supreme Court. Could an iHub suit possible interfere with chances of that being granted ?
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Promised marjac not to mention posters name - but it was argued from number of posters after Appeal loss (rule 36 - FC You answer) that it was the interference from outside that had upset the Judges - even before looking at the Briefs from Singer (being called Vicious Attacks on the Judge DU) - and that Amarin 'never stood a chance' because of this'.
I know these questions might annoy you Law people somewhat - but 'we are at the end of the line (You will agree to that) of Amarins chance of 'US justice system' to even accept to evaluate 'the lost patent case' - so I'm just wondering if 'a motion rule 60' from shareholders (having very slim chance of getting anywhere) - might actually confuse/damage the chances of Amarin being granted Supreme Court valuation ?
eight@ Can't a rule 60 motion - be 'wasted' - with this one word 'DENIED' as it was with En Banc (both iHub Amicus - and actual call 'DENIED') ?
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What reason/arguments is there to think - not just 'DENIED' in rule 60 motion ?
Kiwi@ Thought you ignored me :)
Well - also you part (as BB) of Wallpaper in this Board - and as I said before - If we all agreed on everything - why be in a debate forum :)
ATB
Jasbg