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Thats great vote
Euged Mother lives in Monaghan.I have played many times as a musician in Co Louth.
Very cool you did the tour.JF also did the tour.If we hit $50 we can all go and drink a few gallons
Sounds like a fair deal lol
JF Great song
Make sure it’s Bushmills Whiskey .I may join you from my mothers on the border of Northern Ireland.
Thanks Jimmy.I remember when biib was $40 after ms drug tysabri was taken off the market as i had invested in Elan who developed the drug.They Carl Ichan sacked the ceo and took control by putting 2 directors in place and well the pps speaks.The drug came back on the market and made billions for Biib.If Carl Ichan came onboard with amrn the stock would be $30 overnight on no news.
IBB up 3% why
JF Amen to all said
Agree again .Music helps? I can go into my room and play drums with my favorite hits for hours.I have been in and burned in Bio tech over the years so Amrn at 24 and then 13 doesn’t surprise me.Just make Amrn happen and it’s the last Bio I invest in because life is amazing but being stuck in a stock that I bought at $14 and it goes to $75 cents was devastating .Wishing everyone best with this stock .
Agree.Whats wrong with this board?We have guys calling BO every Monday.Bio thinks 4th of July is July 2nd and Christmas is Dec10th.Somebody used to Quote This is going to take longer than most people think.He was right
Capt is probably the richest guy with amrn here.Very nice man.Met him and his wife in Vegas.I think everyone is edgy coming up to Adcom.Chill
marin's November Rendezvous With A Stepmotherly FDA, And Other Headlines: The Good, Bad, And Ugly Of Biopharma
Oct. 14, 2019 1:39 PM ET|40 comments | About: Amarin Corporation plc (AMRN), Includes: AERI, ARDS, ARPO, HZNP
Avisol Capital Partners
Avisol Capital Partners
The Total Pharma Tracker
How to make money in the scientifically predictable biopharma sector
(9,223 followers)
Summary
Amarin, as we all know, has a November 14 AdCom. What some of us may not know is the history. Covered here.
Amarin has won each battle it has fought with the FDA and its other detractors, and we expect it to win this one resoundingly as well.
Horizon Pharma (phase 3 data), Aerie, and Aridis are some of the other stocks we have covered.
Looking for more stock ideas like this one? Get them exclusively at The Total Pharma Tracker. Get started today »
The FDA has a history of stepmotherly behaviour with Amarin (NASDAQ:AMRN). We saw it between 2013 and 2015, when the FDA issued a CRL to Amarin when the company asked for a very reasonable label expansion - and the FDA took an entire year to even issue the CRL. The saga of those sordid years can be seen in the graph below:
SOURCE
In mid-2015, Amarin filed a suit against the FDA, and a few months later, the court ruled in favour of the company. While us investors were amazed at the spunk of this little company - and the stock did spike a little - the stock took a long time to really recover.
Then finally, last year, the unthinkable happened - the company had incontrovertible proof of how well Vascepa works in patients at cardiovascular risk. This came in the form of the results from the REDUCE-IT trial, which showed - despite its detractors - that Amarin is really worth the trust investors had put into it.
However, the latest gimmicks from the FDA shows us, first, that the regulatory agency is still trying to keep Vascepa down like it did before, but, two, that this is further evidence that Amarin must be really onto something huge, and hence the effort to hold it back.
The latest game that has been played by the FDA sounds eerily similar - a long period of silence, and then a sudden issuance of regulatory decision that is meaningless and harms the stock. Yes, Amarin had 5 million pages of sNDA material from 35,000 patient years of data - it was taking no chances with the FDA. However, surely the FDA didn't notice that only in late August? So, last time, the FDA declared its own SPA with the company null and void. This time, the FDA effectively made its own priority review agreement with Amarin inconsequential by holding back a decision on the advisory committee meeting until the last moment, then declaring one, and thus extending review time to almost what it would have been without the priority review. And all this despite having seen the REDUCE-IT data almost a year ago, giving it enough time to decide whether expert opinion - aka the AdCom - was required or not.
Sometimes one wonders about the games that are played below the radar of public visibility.
So, the current situation - as all Amarin investors know - is that the late September PDUFA date has been replaced by a November 14 AdCom, and then a PDUFA on December 28. Vascepa is already approved as an adjunct to diet to treat very high triglyceride levels, or adult patients with severe hypertriglyceridemia of ≥500 mg/dL, without raising LDL-C or bad cholesterol. The 2013 sNDA was for the next set of patients - those with persistently high triglyceride levels from 200 to 499 mg/dL who are already on statin therapy. The FDA did not approve this sNDA, although the courts determined that Vascepa can market its drug as such, which is not really an approval, but worth it for the drug to make additional millions in sales.
This time, the label expansion is for expanded use of Vascepa to "reduce major adverse cardiovascular events (MACE) in individuals with elevated triglyceride levels, well-controlled low-density lipoprotein (LDL-C, or "bad cholesterol"), and established cardiovascular disease or diabetes."
Now, the September date came through a priority review. Without it, Amarin's date would have been in January. So, this saves it merely a month - thank you very much, FDA.
However, the purpose of this little note - something some investors may not be aware of - is that Amarin has always been a handful for even the FDA. If last time's action is anything to go by, the current low price is a last opportunity of sorts to get in on this drug's success story whose current sales of $400mn is at least a tenth of its predicted sales.
Investors should always keep in mind the tremendously successful results from the REDUCE-IT study. I should keep a sticky note stuck on my work desk with the following words:
Source
Leading to the following table:
Meanwhile, Amarin continues winning every other battle - the big one, REDUCE-IT, the patent battles, the battle against all sorts of misinformation, and some of which I have covered earlier - and we expect it to do nothing less than that in its upcoming struggles with the FDA. Armed with the outstanding results from the REDUCE-IT study, we expect nothing less. January 2020 should bring us a nice little gift in the form of Amarin's stock price hitting the 30s. If it doesn't happen in January, because of some new twist to the FDA tale, be assured it will happen soon enough.
Thanks for reading. Before we end, we want to inform readers that we are in touch with Amarin to get an exclusive interview with CEO John Thero. The interview, if it works out, will be published here on Seeking Alpha shortly, after our subscribers have had a chance to look at it firs
JL Would another theory be that GS are just covering Amrn now because they are getting info from FDA to AMRN and they see small problems that may leave the stock around these levels for a few months and also $17 is not going to drive their clients crazy with $17.I mean 418 would have been a joke
JT said loud and clear 8-8 when adcom was announced on the conf call WE want CVD expansion but didnt mention trigs lowering labeling the whole conf.He was mad .I think the FDA put lower trigs expansion on the table and JT said Shove it and they said back ok LETS PLAY
what% to AV of our profits should we give Twin 20% /30%.You should check in with JL first to see what we should give him,oh and dont forget RAf who almost told us good news
RAF yes I deserve everything mentioned
Louie.Im not going to Adcom but best of luck on the day
Louie I think every amrn investors remember where they were during that fatal Adcom,I was on my way to play a wedding in County Mayo one of the most beautiful scenic views in Ireland but a very bad iphone reception.I had stopped the car to try and get a decent phone service.I was speaking to my father in law on the phone in Detroit who just found out he had stage 4 cancer in his early 70s and my broker also calling me telling me AMRN IS TANKING Its all gone crazy ,its 7 its 5 its 3 its $5 blah blah.I just took a deep breath and counted my blessings and when I counted I WAS $300K short AHHHHHHHHHHHHHHH]lol].I just took in the view and got back in the car and did the gig.
JL he may have forgotten the advice you gave him in 2018.Maybe he would remember what you did for him if you gave him something solid like your new CAR.
If Adcom gives us what we want it wont matter where the party is.
Louie Great to have you at the Adcom.
Not really lol
Capt great to have you and your better half at the Adcom.Best of muck on the day
Raf Bottom line ?Is the news going to add a few dollars to the share price.If not then its useless info
Hopefully by Dec it will be Pfe who will be looking for V approval in Europe
Lovaza banned in Europe with statin
Thanks JM
if he's never taken V how does he know it's a hard to swallow???? If you have never driven your car at 100 mph into a wall how do you know its dangerous.
fly 3 ways to cook an egg
Bio I might be on your last nerve but I think its back to cowboys and Indians here.Surprise is the main advantage here and if wouldcock gets the big questions from you she will have the answer to them all by the time the Amarin legal team come knocking on her door.You are giving her Amrn panel questions to early.I think WOULDCOCK is nervous just like AMRN now and she wants to bring them down,you may actually be helping her KILL Amrn.Dont forget Srpt where she became close friends with the CEO and even though everybody investigating SRPT at the FDA thought it was to dangerous to to allow on the market she said QUOTE they only have one drug so it would ruin the company so she gave it the thumbs up.WHy was she even allowed to have private phone conversations with the CEO of SRPT prior to approval.Was she attracted to him? I think our CEO is a big bear guy so maybe she may be attracted to our ONE product CEO just like Srpt.
Just like Cbd .Boston company can take the molecule out of the plant and put it in a hamburger /steak/banana etc
Agree
Whal people know your games.You should stick with the Lets save Bernie fund.
Bio who said pfe and Nvs made a play for Amrn
Whal How is the Get Bernie Well Again going for you lol.He must be on day 2 of V now
Ibb up almost 2% and Amrn down after JTs amazing conf call @Cantor
Cut JT some slack .He probably hasn’t slept since 24-9-18.He has big funds who bought at $18saying what the fcuk He may not be happy how Amarin people worked The Icer Panel.Hes fed up saying tens of millions .He probably thinks of sheep when he thinks of that line now.FDA are getting difficult to deal with in run up and he feels NOW that it may be hard to get it over the line at Adcom and Dec 28.
The only negative I have with JT is that they have no idea of the names of the countries in Europe so he should have had BP in Europe partners now and saved the stock from going to $11before Adcom.