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Miranda M. Du
CHIEF U.S. DISTRICT JUDGE
Chambers Phone: (775) 686-5919
Courtroom Administrator: Peggie Vannozzi
Administrator Phone: (775) 686-5839
Who is this “daveymoore”! Is this guy for real! Lol
I do remember BB saying that, that’s why I was inquiring about potentially this going OTC to undermine generics.....still holding my position actually add to my fortune, average how 3.53!!
Exactly what I was thinking about OTC, thanks for more of a detailed post!!
Probably the best path, but could they just sale US market and keep international markets?
Amarin should sell this drug over the counter in US market to potentially screw the generic companies if push comes to shove!
You may not be far from the truth!
The error committed by Judge Du is procedural. The error is this - according to Supreme Court caselaw and other precedence, when a judge takes up the two types of considerations, she must take them both together, and not one after the other. In general, already issued patents are entitled to an assumption of validity, and therefore the challenger generic company has to come up with clear and convincing evidence against them, and not the brand that has a burden of proof.
So there are two distinct issues here - one, that the judge must weigh both types of considerations as A plus B and not as A then B; and two, it is not the brand's burden to prove the secondary considerations, but the generic's burden to disprove them.
From Stephenrosenman -ST
AMRN commentary: While AMRN is facing a very different situation today than right after sNDA expanded approval, there is light at the end of the tunnel. On Tuesday, spoke with regulatory attorney with DC B&Covey for perspective. Felt the decision was not atypical given the EPA formulation and prior art that contained a mixture. 35 USC 103 as was referenced leaves open a course for appellate court and felt AMRN was paving a strategy right on up to Superior Court. Opinion was it will be overturned, but quite possibly settled out prior, as generics may not have the profits needed to pursue, given AMRN's supply chain and early pricing strategy. Injunction highly likely and could ensure AMRN years of exclusivity on its own, if appellate court did not reverse prior to a Superior ruling. I remain bullish on AMRN, my short term PT goes to $9-12 but keep my PT of $40 out to 2021. Bullish
Of Overturning Judgment
U.S. District Judge Miranda Du is fairly experienced in hearing patent cases, and her reversal rate is relatively low, HC Wainwright analyst Andrew Fein said in a Tuesday note.
Hikma lawsuit here doesn't relate to patents pertaining to cardiovascular indication (which is why Hikma sought to bar Amarin from introducing REDUCE-IT data in court), Amarin's appeal could be very interesting.
Thanks....generic market in US still a few years away
Food and Drug Administration’s (FDA’s) website, an ANDA for VASCEPA has not been approved, which would be required for launch of a generic product in the United States. The company thus does not believe there is an impending generic launch by the litigants that would compete with VASCEPA at this time.
“Amarin strongly disagrees with
What are the possibility that Amarin sell this drug over the counter!!
There’s no debating his public speaking.....I wasn’t a big fan of going alone but some like the strategy based on greed!
Did he destroy it or did Du’s ruling cripple it for now!
Amarin's Patent Defeat: Current Options https://seekingalpha.com/article/4335110
There’s always a contingent plan!
Over the counter here we come!!
In Canada, VASCEPA has the benefit of eight years of data protection afforded through Health Canada (until the end of 2027)
Geographies outside the United States in which VASCEPA is sold and under regulatory review are not subject to this litigation and judgment
Actually meant to say are Amrn patents invalid
Are patents from FDA invalid! How will the FDA respond to this!
What a waste of money tied up for years!!
Thanks for the information.... I live in Green Valley.
What is the infection rate in Vegas!
There's drug combo to shorten coronavirus, French researchers say
https://www.foxnews.com/science/french-researchers-publish-antimalarial-and-antibiotics-combination-that-could-shorten-covid-19
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Yes. Not so sure as a preventative measure, more of a treatment.
From what I’m reading it’s “not”for a preventive treatment for the virus!Dr. Fauci wants testing from FDA. IMO if the combination of the two work to lessen the virus duration why NOT prescribed to the infected!!
Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial
https://www.sciencedirect.com/science/article/pii/S0924857920300996
From what I’m reading it’s not for a preventive treatment for the virus which that’s what Dr. Fauci is looking for! If the combination of the two work to lessen the virus duration why NOT prescribed to the infected!! That’s what Trump is referring to.
Toxicologist says anti-malaria drugs show 'promise' in treating coronavirus
https://www.foxnews.com/media/toxicologist-reacts-after-trump-announces-fda-making-anti-malaria-drug-available-to-test-covid-19-treatment
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Trump goes all-in on anti-malarial treatment
Mar. 21, 2020 10:33 AM ETAMRXBy: Stephen Alpher, SA News Editor52 Comments
The president yesterday took plenty of heat from the usual suspects for conveying a bit of optimism over an anti-malarial drug that - according to some reports (here's one) - has had great success in treating Covid-19.
He appears to be going all-in on that treatment this morning, minutes ago tweeting out: "HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine."
"The FDA has moved mountains," he adds.
Maybe not in the short term of price movement but adds value to a potential BO
Commercial launch expected to take place in the mid-February 2020 timeframe
How large is HLS Therapeutic sales force?
HLS Therapeutics Announces Health Canada Approval for Vascepa® to Reduce the Risk of Cardiovascular Events $AMRN,HLTRF https://seekingalpha.com/pr/17737432
Is Amarin officially done with FDA after the recent approval !
That’s exactly right!
Moving up fast this morning!! ??
I hope so! I’m tired of this BS! But the open gap is between 18.00-19.00!