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ASM will be in July (as planned now). PRE 14A was issued on 4/15 and DEF 14A on 4/25 … the ASM was on 5/20.
Sometimes during the next two weeks (based on 2011 & 2012).
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Yep.
Best,
G
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It hit twice ...
(i) His parents, Dániel Schula and Mária Miller, were of Hungarian origin. He has always been aware of the family’s Hungarian roots, he spoke the language on a basic level. (In the 1990s he gave a brief interview in Hungarian to ESPN Brasil correspondent André Adler.)
(ii) Moving to the Miami Dolphins before the 1970 season, he became the first NFL coach to win 100 games in 10 seasons. In 1972–73, the Dolphins became the first and only team to go undefeated through an entire season and the playoffs, culminating in a Super Bowl victory. The Dolphins won it all again the following year, and twice reached the Super Bowl again before Shula retired after the 1995 season with an NFL-record 328 wins.
Best,
G
TI- (HinduKush / 271180)
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TI- (& Will Lar / ps)
UPDATE: Thx 271160
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c- (invest2992 / 271078)
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ps.: marzan / 270878 & invest83838 / 270910
z- (& rosemountbomber / 271070 & MontanaState83 / 271071)
To put in a context of GIA in Europe (or in any country / region):
Settlement: The chance is next to nothing.
But let's assume the parties will find an acceptable settlement (not likely*) it will means nothing, very little.
Markman Advisors is spot on … vacatur of the Bench Order is not likely. The court refused to vacate an invalidity decision in Protegrity USA, Inc. v. Netskope, Inc., Case No. 15-2515 (N.D. Cal.).
- The settlement during appeal means for dissatisfied litigants to vacate previous unfavorable decisions. (Bates (quoting Ringsby Truck Lines, Inc. v. W. Conf. of Teamsters, 686 F.2d 720, 721 (9th Cir. 1982))
- It is known the vacatur will mean Amarin will use the patents again against other generics. However, it would result in unnecessary relitigation of issues that had already been adjudicated in the original judgment.
This case is similar to 'Protegrity'.
Best,
G
* The settlement is more important for Amarin than for the generics. Vascepa is just one product for them .. is not THE product. H & R are well ahead of other generics - e.g. have a submitted ANDA - the smaller but less fractioned market could worth more for them than the bigger market with more players.
The market will be bigger slowly - w/o Amarin education - but will be bigger, the difference is not necessarily "huge" for H&R.
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(Relevant) Events:
Dancing in the dark: If you think, please replace my previous post (sticky) with this one. Thx.
May
- Federal Court of Appeals (FCA) decision about “Unopposed motion to expedite briefing and oral argument”
- May 12: Plaintiffs-Appellants’ Opening Brief (FCA), (expedited or normal)
June
- June 16: Defendants-Appellees’ Responsive Brief (expedited … June 21 / normal: 40 days from service
of opening brief))
- June 26: Plaintiffs-Appellants’ Reply Brief (expedited … July 1 / normal )
July
- July 17: Response to Day 120 list of questions (LoQ), March 26 (Please note: all EMA deadlines – below – are based response by July 17. Amarin has three months to answer the LoQ but the no clock restart in June.)
August
- (Week 32) Q2 2020 (10-Q and CC)
September
- Week 36 (August 31- September 4): Oral argument (FCA) …Meanwhile July / August is technically possible, it is not likely, September is the earliest, realistic time in any scenario but could be late
- September 17: Day 180 Opinion / recommendation of approval by EMA (if no more issue) or List of Outstanding Issues (LoOI)
- Decision about EU approach (partnership or GIA or hybrid)
November
- Week 45: Q3 2020 (10-Q and CC)
- November 23: Commission Decision / formal approval (based on Day 180 Opinion by EMA, September 17)
December
- December 23: Response to Day 180 LoOI, September 17 (Amarin will have three months to answer the LoOI.)
- Chinese MARINE trial completion / result
January
- Order (FCA) (average time is 4 months after oral argument)
- January 28: Day 210 Opinion by EMA / recommendation of approval
February
- Healthcare professional and consumer launch: Delayed until after sales representatives can resume face-to-face meetings and pending successful ANDA appeal
April
- April 5: Commission Decision / formal approval (based on Day 210 Opinion by EMA, January 28)
Note:
a.) dates are (i) all “on or before” (ii) lot of them TBA or TBC
b.) EMA approval calculated by the “longest” (3-months reply) timeframe due to changed communication by the company.
“Our expectation is that VASCEPA will be approved near the end of this year for launch in Europe” vs. “recommendation for approval of VASCEPA by the European Medicines Agency near the end of this year” (latest).
Amarin “speed” (reply) will depends (IMO) on the appeal procedure: expedited or normal
c.) if something will be sometime during the relevant quarter it is listed for the last month of the quarter
Best,
G
ps.: alternative EMA timetable, calculated by the 2-months reply
- May 22: Response to Day 120 list of questions (LoQ), March 26
- July 23: Day 180 Opinion / recommendation of approval by EMA (if no more issue) or List of Outstanding Issues (LoOI)
- September 28: Commission Decision / formal approval (based on Day 180 Opinion by EMA, July 23)
- September 15: Response to Day 180 LoOI, July 23
- October 15: Day 210 Opinion by EMA / recommendation of approval
- December 21: Commission Decision / formal approval (based on Day 210 Opinion by EMA, October 15)
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Thx to sticky my previous post about "events".
If you think, please replace with this one.
Thx.
G
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Why post / discuss something that is known for years? These were a 'vest', not a 'grant'.
Best,
G
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I do not have an inside info … just reading the 10-Qs/Ks …
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(Relevant) Events:
Mod: If you think, please replace my previous post (sticky) with this one. Thx.
May
- Federal Court of Appeals (FCA) decision about “Unopposed motion to expedite briefing and oral argument”
- Plaintiffs-Appellants’ Opening Brief (FCA), May 12 (expedited or normal)
June
- Defendants-Appellees’ Responsive Brief (June 16 / expedited … June 21 / normal: 40 days from service
of opening brief))
- Plaintiffs-Appellants’ Reply Brief (June 26 / expedited … July 1 / normal )
July
- Response to Day 120 list of questions (LoQ, March 26), July 17 (Please note: all EMA deadlines – below – are based response by July 17. Amarin has three months to answer the LoQ but the no clock restart in June.)
August
- (Week 32) Q2 2020 (10-Q and CC)
September
- Day 180 Opinion / recommendation of approval by EMA (if no more issue) or List of Outstanding Issues (LoOI): target date: September 17
- Oral argument (FCA) …Meanwhile July / August is technically possible, it is not likely, September is the earliest, realistic in any scenario but could be later … especially if expedited request will be denied (Please note: Independently from expedited or normal procedure, Amarin – most likely – will file Plaintiffs-Appellants’ Opening Brief /May 12/. The last document /Plaintiffs-Appellants’ Reply Brief /– will due: June 26 (if granted as expedited) … in normal procedure it will not be much later: early July.)
- Decision about EU approach (partnership or GIA or hybrid)
November
- (Week 45): Q3 2020 (10-Q and CC)
- Commission Decision / formal approval (based on Day 180 Opinion by EMA on September 17, target date: November 23)
December
- Response to Day 180 LoOI, December 23 (Amarin will have three months to answer the LoOI.)
- Chinese MARINE trial completion / result
January
- Order (FCA) (average time is 4 months after oral argument)
- Healthcare professional and consumer launch: Delayed until after sales representatives can resume face-to-face meetings and pending successful ANDA appeal
- Day 210 Opinion by EMA / recommendation of approval (target date: January 28)
April
- Commission Decision / formal approval (based on Day 210 Opinion by EMA on September 17, target date: April 5)
Note:
a.) dates are (i) all “on or before” (ii) lot of them TBA or TBC
b.) EMA approval calculated by the “longest” (3-months reply) timeframe due to changed communication by the company.
“Our expectation is that VASCEPA will be approved near the end of this year for launch in Europe” vs. “recommendation for approval of VASCEPA by the European Medicines Agency near the end of this year” (latest).
Amarin “speed” (reply) will depends (IMO) on the appeal procedure: expedited or normal
c.) if something will be sometime during the relevant quarter it is listed for the last month of the quarter
Best,
G
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FYI: