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Don’t underestimate how much the GSK v. Teva ruling has changed the analysis. Everyone thought this could be overturned on en banc. That will not be the case anymore. The generics are limited based on this ruling and I imagine a BP’s legal department will come to the same conclusion.
Judge Newman knew what she was doing and was tired of generics using the skinny label parhway to trample on patent rights.
Hikma and company thought this decision would be overturned especially after all the amicii weighed in with their briefs. Even Henry Waxman weighed in. Guess what: en banc still denied. Judge Newman is in her 90s. She is the OG on that court and is very respected by the Supreme Court. Generics are backed into a corner and face the lost profits damages. The lawyers at Hikma cannot be pleased with the GSK ruling. Uncertainty here does not favor the generics due to the damages threat.
Again this decision came out Thursday. It’s only been 2 days. Its implications are still festering.
If that is true, that price reduction is comical especially considering this week's past events. Wall Street is not your friend.
From the Bloomberg law article:
"The new ruling, which places a greater emphasis on the label itself rather than just the press releases, marks a low for generics relying on the routine practice of carving out certain uses of copycat drugs to avoid infringement of name brand products, and might actually have been worse than the original decision said Scott Lassman an FDA law and policy attorney with Lassman Law.
"It's going to make it more difficult for companies to avoid infringment through standard carve outs," Lassman said.
That is what law is. No case has 100% the same facts. If they did there would be no reason to try the case.
Law is about analogizing to prior cases that are in your favor. The GSK decision today definitely helps us. A first year law student could point this out.
Again, if you are the legal counsel for a generic are you going to risk going to trial. It's a different risk calculation this time because of the damages.
And we now know the en banc hearing was denied which means this case is new case law....precedential at that.
The label is just one example. Hard to get around one is obtaining more than X percent of a market. If the market is X big and one is now getting X plus that is further evidence of infringement.
The question is do the generics want to roll the dice on a jury trial where damages could be significant. This time around the generics are the ones who stand to lose a lot. The risk reward is asymmetric.
Don't let today's share price fool you. The past two events: GSK ruling and our case vs Hikma and HealthNet, which is ongoing, have shifted the calculus in a major way against the generics.
We now have the GSK ruling which we can use as a precedential case to help us and we have certain facts from our case which we know to be true: generics did not have a CV limitation on their label.
Moreover, the lawyers for Healthnet are probably thinking Hikma what have you dragged us into.
This is huge for Amarin. It may take a few days for the market to figure it out but the landscape for the generics has shifted in a major way.
The more the generics try to creep up and obtain more than the very high TG market the more it will only hurt them in the end by further proving infringement on the CV indication. This GSK ruling is huge.
And btw: the CAFC has indicated no en banc hearing. Sorry Teva you lose.
LOL with this GSK news this is a great day for us.
Judge Newman came through for patent holders.
Correct. En Banc hearing was denied.
GSK v. Teva decision out this morning.
You got the vaccine after you had COVID or before?
CEO is gone, Chief Legal Office is on his way out and now Chief Medical Officer.....not to mention the Head of IR (Elizabeth and I think her replacement).
On top of that we had that 8-K issued earlier this year pertaining to compensation of executives even at the VP level who are let go upon a change of control......
These are all positions you would not need upon acquisition...."synergies" a.k.a cost cuts from duplicative roles....
all very interesting.
LBL--What do you make of Craig Granowitz's departure?
Breakthrough infections in health care workers---New England Journal of Medicine
https://www.nejm.org/doi/full/10.1056/NEJMoa2109072
Great questions. How can the company be certain that the namenda washout period was long enough......
Curious to know the answer to that.
Amarin has not shown to be that proactive.
This is Amarin....everything moves at a snail pace.
Covid treatment options remain elusive.
New article in WSJ: https://www.wsj.com/articles/covid-treatment-delta-variant-cases-symptoms-11627312440?mod=hp_lead_pos5
Great post.
LBL---you still here?
Good post. How confident are you that results will be positive? Given all the bad luck we’ve had and the naysayers (Nissen, Adam F., etc) seems like we will need slam dunk results to matter. Evaporate was a whimper.
Your thoughts?
LOL. you are not going to see $26 per share again.
Management blew that.
Have to always takes some profits with bios.....
PS: Vascepa did not "sell itself" as a famous poster proclaimed it would do
Interesting post from JL re: Vascepa & Covid.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=164888369
When do we expect Prepare-IT results to be released?
Look who said something similar.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=164626468
The article completely missed regulatory exclusivity (10-11 years) in Europe.
These articles have an agenda. Stay informed and do your own due diligence.
On the one hand the market cap looks absurd compared to other Alz plays but then you have to consider this is still Alz, which is extremely complex given the vast amount of failed Alz trials.
I thought Neurotrope's last trial had a good chance of success and look how that ended up.
Alz is a very complex illness as often pointed out by Dr. Dale Bredesen who authored the End of Alzheimer's. An important read for those trying to understand the complexity here. To truly ameliorate Alz you may need a combo therapy and perhaps this drug may be part of such therapy but we are trying to correct bad dieting, lack of exercise from someone over a lifetime, and inflammation in the body that has led to his/her Alz. One drug may not be the panacea for that.
I'm invested but will probably take some risk off the table if the stock appreciates closer to the trial readout. This is still biotech. There are various ways to play this from an investment standpoint. I'm hoping the anticipation of the readout leads to increased share price to take some chips off the table.
P-dude did you see this:
https://www.reuters.com/world/americas/argentina-announces-covid-19-vaccine-supply-deal-with-moderna-2021-07-08/
Argentina signs supply deal with Moderna. Perhaps they would do something similar with Amarin if results are positive. Let's hope those results are ready soon.
Got it, thanks! Fingers crossed.
This is in Argentina right? How do you think it plays out if the trial is successful.....
Argentina asks for a supply of Vascepa.....? Contracts with AMRN?
The stock was at $6.50 when JT announces he was retiring. Before that we hit $9 and change on European approval.
Now we sit in the low $4s.
Look at the destruction in value.....management has been relatively silent.
You view it as incompetence and I view it as the article i posted mentioned......there's a severe disconnect between reality and share price....something is up (your company is getting acquired)
From the article:
10. Your stock has become disconnected from reality
Let’s say your stock’s fair value is $80. Your company earns $2 in profit per share, per quarter. There are about 91 days in each quarter. This means your company is adding about $0.022 per day to its fair value.
In a perfect world this would be reflected in your stock price. Each day of the week your stock would go up $0.022. On Friday it would go up by $0.066 to account for the weekends.
Obviously there are other factors at work, but this type of thinking should give you an idea of where your stock should be heading, and how quickly.
It becomes painfully obvious that your stock is being manipulated if instead of going up a little bit each day, it goes down a big amount.
The larger the spread between what’s happening, and what should be happening, the larger the chance of a buyout..
Take your frustration out with management not with me.
Ok lol.
this is worth a repost:
https://www.griproom.com/fun/10-signs-your-company-is-about-to-be-acquired
company's silence is deafening.
JT owns a lot of shares.........
again read the post.
What happened to the $12.86 you predicted upon EMA approval?
Where is the volcano you talked about.......
Since you are now calling for a triple bottom just curious why we never saw the $12.86?
Do they even know about AMRN on Reddit / Wall Street Bets?
That would be the ultimate redemption story.
The difference here is that the CVD market is exclusive to Amarin. The generics can't make the claim they need supply for CVD market, which is the larger market.
Great to hear from you. But why doesn't management / JT speak more directly on this....connect the dots for Wall Street.
Our stock is at $4.40
Market cap of $1.7 bn with $539 mm of cash, no debt, and $900 mm of tax loss carryforwards.....
We are stuck trading between $4 and $5 bucks
Thanks for posting.
Regulatory exclusivity expected for 10 years from March 26, 2021 approval, possibly 11 years. That was from one of the slides. Clock is ticking.
Good to see $539 mm of cash and $900 mm of loss carryforwards. Now look at our market cap. Wow.
Good luck thinking folks will put masks on again. Very few have masks on now. Will be hard to reverse. I just read even buffets are back.
And yet management remains silent. Crickets.....
you can't make this stuff up.
Very well stated. Let the countdown to Aug. 1 begin.
Could be a market in the USA for the anti-vaxers.
Will be interesting to see if the stock price reacts to the August presentation / late-breaker.