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Looks entirely generic. I did note, probably noted here long ago, that DCVax direct completed its phase one trial and is moving to phase two and also it seems evident that further dilution will be necessary to fund ongoing operations.
Are you not into yoga? Do you have half a brain.
I hope their fate doesn't befall us. You would expect Javitt would design a suitable study since he was FDA but I recall he was tap dancing around the data because some hospitals were overrun with patients and couldn't carry out the study effectively. On the face of it his point makes complete sense but the only opinion is that of the FDA. Fingers crossed.
Oh, by the way. The FDA just ended cydy. Brutal.
It doesn't matter if he's right or not in the world of stocks. How long before AF takes this and runs with it? On top of the current legal issues this can only serve to depress the stock price further. Public perception is everything. It will take months to refute thus.
In any case, I've closed out my position here which was small and don't expect to buy back in barring some miracle in the courts. So, last post. Good luck to all.
Heh. Well, ok.
Doesn't matter. The study is out there. So as well as dealing with legal issues, the company now has to deal with this new attack on the efficacy of their drug.
Is this a death blow for vascepa?
Higher blood levels of omega-3 fatty acids from prescription fish oil showed no effect on CV events
https://medicalxpress.com/news/2021-05-higher-blood-omega-fatty-acids.html
Or back down to 1.50. Without news there's no reason to expect the price to continue upwards.
The share price says news but the volume doesn't. Until proven otherwise I think this is a pump and dump. We'll close at 1.50. JMHO
That's an amazing video.
I wonder who knows the aynswer? Not me. shrug
Now you're sounding like exwannabe. Please tell me you're not turning into a wannabe ex. ;)
Just that the original hls trial from last year posited a potential anti viral effect from vascepa and the trial results were positive.
http://hlstherapeutics.investorroom.com/2020-12-14-HLS-Therapeutics-Reports-Efficacy-and-Safety-Results-from-Pilot-Study-Treating-COVID-19-Infected-Outpatients-with-Vascepa-R-Icosapent-Ethyl
The method of action of vascepa in covid is still to be determined but it is proving to reduce inflammation.
Well at least it's up over 12% this morning on the Swiss exchange. That's just two cents though.
Hope we make the cut.
FWIW
Amarin PLC Stock Appears To Be Possible Value Trap
https://www.google.com/amp/s/finance.yahoo.com/amphtml/news/amarin-plc-stock-appears-possible-161209743.html
Down sharply today if you believe the Swiss.
Cayenne pepper. Go easy on it though.
Certainly possible. Do you think the narrowing of scope makes it unlikely to benefit Amarin even if the court finds for Glaxo again? And of course, there's the inevitable appeal.
If we close at 5.63 I'll buy you a bottle of McAllen's finest and you can tell me where to send it.
The court has already narrowed the scope of the appeal and even if Glaxo wins it will be appealed again but I think Teva will prevail because the court, seeing that they might have weakened generics ability to use a carve out, won't want to overturn established precedent. Just my uneducated opinion.
As for the narrowed scope see the excerpt:
Recent developments, however, suggest that the dispute in GSK v. Teva may be shifting away from the larger statutory and policy questions regarding “section viii” and “AB-rated” generics – and towards a narrower, factual dispute regarding the contents of Teva’s 2008-2011 generic labeling. In its January 29, 2021 response to Teva’s Petition (“GSK’s Petition Response”), GSK argued that Teva did not actually “carve out” the patented “congestive heart failure” indication – but rather “left in” language sufficient for the jury to find “run-of-the-mill” induced infringement based on express “encourage[ment]” by Teva’s label itself.[ix] GSK further contended “that finding is implicit in, and necessary to, [the panel majority’s] decision,” which “noted [Teva’s] label provided evidence from which a jury could conclude Teva encouraged the patented use.”[x] Accordingly, GSK dismissed Teva’s concerns of “section viii nullification” as an unrealistic “doomsday scenario,” contending that the majority opinion “reiterate[d] that generics who wish to [enter the market with partial labels] must comply with section viii by completely carving out the patented use.”[xi] According to GSK: “As long as generics fully carve out the patented use, they can continue to enjoy the carve-out statute’s protection.”[xii]
And on February 9, rather than granting en banc review, the Federal Circuit granted a panel rehearing for February 23, 2021, on the “limited” issue of “whether there is substantial evidence to support the jury’s verdict of induced infringement” for the “partial label” period between 2008 and 2011.[xiii] While the outcome remains to be seen, it is possible that the panel majority may use the rehearing to refine its original opinion on the evidentiary issues raised by GSK – i.e., whether Teva’s label was insufficiently “carved-out” to avoid inducement – rather than focus on the broader legal questions regarding induced infringement of completely “carved-out” uses that Teva and its amici urged for en banc review.
Good question.
The only comment I can make regarding your post is that a think teva will prevail on appeal. Glaxo drew an inside straight when they got the three judges they did at the appeals court. Everything else you mention imo flows from that supposition on my part.
It hasn't yet been proven in court that Hikma infringed although that's the consensus here. That's what I meant by yet to be proven. The only opinion that matters is that of the court.
As for the SC case, any percentage above 1% they will even hear the case is rampant optimism. I concede that if they do take the case Amarin's chances go through the roof.
Perhaps I misunderstand the mood here when I see posters commenting about pending cases with the expectation that Amarin will receive a favorable opinion without regard as to whether the case will even be heard. My bad.
Would they be any more responsible for infringement than say a tv manufacturer unknowingly selling tv's with chips in them that (yet to be proven) violate a competing chip manufacturer's patent?
As an aside, this board's history in predicting an outcome in any of the legal issues Amarin has been associated with has been so absolutely dismal it's a safe bet for anyone to take a contrarian view to the consensus of posters here. Just on that observation alone I will take the view that the SC will not hear Amarin's appeal, Amarin will lose this case with Hikma and the rule 60 appeal will be denied with no comment.
The sooner Amarin puts all these legal issues behind it the sooner mgmt can focus on the future, which is ROW.
Serious. They sell approved generics and hikma has an approved generic for vascepa. If they've infringed it would be because they followed hikma's label. I would be willing to bet they are able to remove themselves from this lawsuit.
What about their statement that they are legally prohibited from selling prescription drugs? If that's accurate then I can see their point.
If I read those opinions correctly there's no inconsistency. The first revolved around the right of a tribe to sell horses on their land as they saw fit. The second revolved around horses on federal land and followed BLM policy.
Railing at judge Du for these cases is absurd. Judges are required to follow the law and personal feelings are not supposed to enter into it.
Thanks for pointing that out Adam . I missed that.
Great article and very encouraging. Thanks for posting it.
The SC appears to be looking for a test case but Teva Glaxo is the better option because it's a disputed case at the appeals level. No juris ex machina is going to save us.
It's a premarket pump followed by an all day dump. See Friday's chart .
So, one down, two to go. There's very little chance the SC takes Amarin's case. The future for Amarin lies in Europe and China, eventually other countries but not in the US. It's ironic that our own patent laws have been the instrument of Amarin's failure in the US. Maybe sell a generic version here but that's about it. Maybe Amarin should become a generic itself and concentrate on stealing other companies patents. That seems to be where the future lies.
You have me picturing a naked shart. Thanks for that. :/
Very heavy volume early. And down.
In clinical trials, Vascepa was associated with an increased risk of atrial fibrillation or atrial flutter (irregular heart rhythms) requiring hospitalization. The incidence of atrial fibrillation was greater among patients with a history of atrial fibrillation or atrial flutter. Vascepa was also associated with an increased risk of bleeding events. The incidence of bleeding was higher among patients who were also taking other medications that increase the risk of bleeding, such as aspirin, clopidogrel or warfarin at the same time.
https://www.fda.gov/news-events/press-announcements/fda-approves-use-drug-reduce-risk-cardiovascular-events-certain-adult-patient-groups#:~:text=Vascepa%20is%20taken%20orally.,atrial%20fibrillation%20or%20atrial%20flutter.
Fourth reference for the article
Bhatt DL, Steg PG, Miller M, et al. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med. 2019;380:11-22.
We're already partnering in Canada and China.