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We really don't know ...
I wonder if the PFE incentive ...
The period of market exclusivity should be counted as starting from the date of notification of the marketing authorisation decision to the MAH, which can be found in the Official Journal of the European Union as well as in the Union register of medicinal products for human use on the European
Commission website.
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-procedural-advice-users-centralised-procedure-generic/hybrid-applications_en.pdf
3/26/21
https://www.ema.europa.eu/en/medicines/human/EPAR/vazkepa
Yep, exactly the same ...
Amarin/Pfizer can potentially promote Vascepa for COVID-19
If this is horseshoes ...
Germany Vazkepa launch event - 9/11/21
https://amarinlaunchevent.de/programm/
en francais s'il vous plait
Easiest way to success in France
is through their Canadian French-speaking brethren. Mikhail's fluency in French won't hurt either.
IPE Symposia - For Francophiles and Anglophiles
Sept 10/11 2021
https://www.investorvillage.com/uploads/87669/files/IPE_Symposia_INVITE_p14.pdf
https://events.myconferencesuite.com/IPE_Webinar/reg/landing
Somebody call Turley
Nice call Lem - UK updated as you predicted.
Court-packing is just another fever dream
Let's just say there really are 53% unanimous opinions this term, across a mere 39 decisions. Well, there were 46% unanimous opinions by the Court in the rest on Roberts' time as chief, with a more evenly split court, across 1148 cases. That's a much tougher feat. And of course they save the hard decisions for the end of the term, so we'll see what the final percentage is this term. In fact I would predict much more division in next term's decisions because the conservatives have mustered their forces in the cert review process this term. Will Turley then say, "the Court's heightened division indicates the Court is showing it is in favor of expanding the number of justices."
9 · 0 n= 412
8 · 0 n= 116
7 · 0 n= 3
8 · 1 n= 65
7 · 1 n= 117
7 · 2 n= 27
6 · 3 n= 112
6 · 2 n= 39
5 · 4 n= 218
5 · 3 n= 36
5 · 2 n= 3
Four day lags before e-docket re-distribution entries made.
That would be my best guess.
Doubtful. Court still wants to do due diligence.
The Relist
Supreme Court practitioners looking for clues about what cases the justices might select to fill out the rest of their docket know to watch for ones set aside for additional consideration.
In recent years, one of the more reliable signals that the justices are interested in hearing a case is when they take up a petition at conference and then hold it over for further consideration.
The relist, as the practice is known, began in 2013 and is meant to give the justices and their clerks a chance to check for procedural obstacles that could prevent them from ruling on the issue they ultimately want to address.
With the first set of relists for 2021 coming up for consideration, Bloomberg Law has put together a primer on this relatively recent addition to the high court’s list of opaque practices.
1. What’s a Relist?
The private conference is a justices-only meeting, which typically occurs on Fridays. The court’s most junior member—Amy Coney Barrett at the moment—keeps notes and answers the door when necessary.
The justices discuss some of the petitions that have been “distributed” for conference among the more than 1,700 they receive each term. The ones they look at have gone through the court’s briefing process, which can involve asking parties for more information.
It takes just four justices to grant certiorari, meaning they’ll hear argument and render a decision.
If there are four votes for cert., the justices typically will relist the petition for another private conference.
It’s thought that during the week between conferences, the court’s clerks will check to see if there are impediments to deciding the ultimate question.
Are there standing issues, or those allowing the suit in the first place, that the lower court overlooked? Problems with the court’s jurisdiction? Have the parties changed their positions since arguing in the lower courts such that the justices should allow them to consider the issue first?
2. Why Did it Start?
Most of the court’s docket is discretionary, meaning that the justices get to pick the cases they want to hear.
The Supreme Court typically agrees to hear fewer than 70 cases each nine-month term. That’s less than 50% of the average opinion output for each court of appeals judges—who hear cases all year—and significantly down from the approximately 150 signed decisions the justices issued as recently as the 1980s.
Every time the high court dismisses a case due to an unforeseen hiccup, it not only lowers that already depleted number, but it also wastes time, money, and resources of the parties and the court.
That’s why relist guru John Elwood, a partner at Arnold & Porter who has argued nine Supreme Court cases, suspects the justices began consistently relisting cases.
Elwood noted in 2014 that just prior to the court’s new relisting practice the justices had dismissed as improvidently granted—or DIG—two cases after briefing and argument. That means they shouldn’t have taken the case to begin with—as big an oversight as the court is prone to make.
The relist “may be akin to a ‘stop, look, and listen’ after a provisional decision to grant—intended to give the Justices and their clerks additional time to review grant candidates for vehicle problems or other concerns,” Elwood said.
3. What’s the Significance?
A majority of cases granted since the court implemented the practice have come from the relist.
One time on the relist greatly improves the chances of a grant, as it signals that the justices are interested in the underlying dispute.
But if a problem is found, they’ll look for another to address the issue.
Importantly, the more times a case is relisted for conference, the more likely it will be denied—often with some kind of opinion from one or more justices.
A relisted case could simply occur to give a justice time to write a separate opinion on the court’s decision to not take it up. That can be a “statement respecting” the court’s decision to deny review, a concurrence with the denial, or even a dissent.
4. Are There Exceptions?
Like all things in the law, yes, there are exceptions. A big one are grants from the so-called long conference. This takes place just before the justices officially kick off their new term in October and considers the petitions that have been piling up over summer.
Presumably these cases have been pending long enough for clerks to check for problems before the first conference.
The justices will occasionally fast-track a petition by not relisting it if it was brought by the U.S. Solicitor General’s Office—the federal government’s top lawyer at the high court and a trusted voice commonly referred to as “the tenth justice.”
And the court may relist cases when time is critical. That happened in a habeas case in 2016 that went from grant to briefing to argument to final opinion in just over three months—lightning speed at the Supreme Court.
5. Is it Hard to Spot a Relist?
To spot a relist just look at the court’s docket. It will have two entries noting that the case was distributed for conference.
For example, the court granted securities case Goldman Sachs Group v. Arkansas Teacher Retirement System on Dec. 11.
Prior to that, the case had been considered at both the Dec. 4 and Dec. 11 conferences. A successful relist grant.
Watch out for “rescheduled” cases. These dockets will often look similar, noting that the case has been considered at multiple conferences. But they’ll have an additional docket entry that simply says “Rescheduled.”
No explanation is given, but any single justice can request that a petition be rescheduled for any reason.
Rescheduled cases are not considered at conference and no vote on whether to grant the case takes place. If the justices eventually decide to grant a rescheduled case it will set the case for at least two more conferences.
https://news.bloomberglaw.com/us-law-week/supreme-court-adds-layer-of-due-diligence-relists-explained
Amarin needs conference distribution a second time.
If the past is any guide.
The 2019 term: This term had two unscheduled conferences at the end, so by definition all the cases were re-distributed. At that last conference, six were granted and three were denied – and there were no more. Most were Government agency cases that had been percolating for months. These were cases that had been thought about for awhile, and decisions had to be made. At the next to last unscheduled conference, most cases were pushed forward from last scheduled conference. Five were granted, ten were denied. Contrast these two unscheduled with last scheduled conference: zero granted, approximately 110 denied.
The 2018 term had an unscheduled conference at the end, where cert was granted to 13 cases and cert was denied for 12 cases. Of the cases granted, all had been distributed for the last scheduled conference, and then got bumped forward. Half were Trump Administration cases that had been distributed multiple times. The last scheduled conference had 8 certs granted and 100+ denied. The grants had been distributed at at least the immediately preceding conference as well. Another unscheduled conference preceded the last scheduled conference – five complex financial cases involving Puerto Rico were consolidated and granted cert; no other cases were considered.
The 2017 term: at a final, unscheduled conference, seven cases were granted cert and 19 were denied. At the preceding scheduled conference, seven were granted and a jillion denied. All of the grantees had been distributed for the immediately prior conference as well.
The 2016 term: at a final, unscheduled conference, six were granted cert and 7 were denied. At preceding scheduled conference, two were granted and a jillion denied. Both the grantees had been distributed for the immediately prior conference as well.
[My use of the term “unscheduled” means that the conference was not listed on the Supreme Court calendar, which are probably drawn up before term begins.]
Re-distributing happens.
Don't think there's redistribution category on Order List.
What! You want me to take a position?
ggwpq - tough to figure out for all cases
Shouldn't count as "real" cert grants.
Would have been a 0 in my table.
Yes, but unscheduled conferences pop after term usually.
End of term cert grants over time
https://www.investorvillage.com/smbd.asp?mb=2294&mn=8549&pt=msg&mid=22098500
Last year July 9th cert orders were anomaly
End of June is traditional term end.
At least in terms of weekly conferences. Then there will Order List from the last conference. They can and do issue Miscellaneous Orders over the summer months but these are rarely cert grants because they are not holding conferences. New term starts first Monday in October, and weekly conferences start up shortly thereafter.
End of term cert grants last year
https://www.investorvillage.com/smbd.asp?mb=2294&mn=8548&pt=msg&mid=22097537
Because ICER previously conducted economic assessment on Vascepa.
Particularly if experiences with these specific insurers
ICER examines insurance coverage policies pertaining to Vascepa
On May 12, 2021, the Institute for Clinical and Economic Review (ICER or the Institute) released plans to begin an annual examination into health insurance drug coverage policies to assess “fair access” to prescription drugs. The purpose of the examination and resulting report is to promote dialogue with regard to whether “insurers are providing appropriate access for drugs that have been responsibly priced.”
The Institute’s decision to look at payer policies that may limit access to care appears to be a signal of its independence and willingness to explore concerns involving both manufacturers and payers. Those who have followed ICER closely will know that the organization has worked productively with a number of patient groups and has issued final assessments that include recommendations that payers abolish or limit the use of certain utilization management tools in certain cases.
In its latest endeavor, ICER plans to examine the coverage policies — including cost sharing, clinical eligibility criteria, prior authorization processes and step therapy protocols — of 15 U.S. commercial payers to determine if they provide fair patient access to 28 commonly used prescription drugs (as assessed by ICER according to a subset of its fair access criteria).
ICER’s report is projected to be released in the fall of 2021. Any payer with policies that ICER deems not to meet its fair access criteria will be provided an opportunity to provide comment on the assessment prior to publication.
https://www.faegredrinker.com/en/insights/publications/2021/6/icer-turns-attention-to-health-insurers-new-report-will-examine-whether-plans-provide-fair-access-to
Supreme Court dispositions over the years (1946-2019)
stay, petition, or motion granted - 45
affirmed (includes modified) - 2692
Reversed - 1988
reversed and remanded - 2431
vacated and remanded - 1098
affirmed and reversed (or vacated) in part - 76
affirmed and reversed (or vacated) in part and remanded - 166
Vacated - 34
petition denied or appeal dismissed - 353
certification to or from a lower court - 13
no disposition - 1
--------------------------------------
no favorable disposition for petitioning party apparent - 3245
petitioning party received a favorable disposition - 5765
favorable disposition for petitioning party unclear - 5
Reasons Roberts' court grants certiorari and ultimate dispositions
Cert reasons
3.79% case did not arise on cert or cert not granted
27.60% federal court conflict
0.71% fed court conflict & resolve important/sig question
0.09% putative conflict
1.50% conflict between federal court and state court
0.88% state court conflict
1.06% federal court confusion or uncertainty
0.26% state court confusion or uncertainty
0.53% federal court and state court confusion or uncertainty
2.29% to resolve important or significant question
18.25% to resolve question presented
42.59% no reason given
0.71% other reason
N=1137; 2005 - 2019 terms
Disposition once case is taken
31.98% no favorable disposition for petitioning party apparent
67.85% petitioning party received a favorable disposition
0.17% favorable disposition for petitioning party unclear
N=1154; 2005 - 2019 terms
If there was a remand, no new evidence.