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r-
Reverse 75+%*
Affirm 20+%*
Remand <5%
Settle 0.00% (-100% ....)
Best,
G
* subject to change
B-
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P- (& HinduKush)
My post was not about V vs gV or about anything but (as I quoted)
P-
If somebody would like to read the two (three) USPTO documents:
- 2-16-cv-02525-MMD-NJK - Doc 89 - Exhibit 27
- 2-16-cv-02525-MMD-NJK - Doc 262 - Exhibit 18
It is available "across" the sticky ( 20-1723 Appeal (& 216-cv-02525-MMD-NJK) ) or directly: DC; 216-cv-02525-MMD-NJK Available documents
Best,
G
ps.: maybe additional USPTO docs are available in other docs also
(Relevant) Events:
Dancing in the dark: If you think, please replace my previous post (sticky) with this one. Thx.
June
- June 26 : Plaintiffs-Appellants’ Reply Brief (CAFC)
July
- July 1: Joint appendix (CAFC)
- July 6: Preliminary Q2 (TBC)
- July 17*: Response to Day 120 list of questions (LoQ), March 26 (Please note: all EMA deadlines – below – are based on response by July 17. Amarin has three months to answer the LoQ but the no clock restart in June … *clock restart)
- Healthcare professional and consumer launch
August
- Week 32: Q2 2020 (10-Q and CC)
September
- Week 36 (August 31- September 4): Oral argument (CAFC) …Meanwhile August is technically possible it is not likely, September is the earliest, realistic time but could be later
- 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)
October
- October 5: Preliminary Q3 (TBC)
November
- Week 45: Q3 2020 (10-Q and CC)
- November 23: EU 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 (CAFC) (average time is 4 months after oral argument)
- January 28: Day 210 Opinion by EMA / recommendation of approval
April
- April 5: EU 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 (“longest”) EMA timetable
- June 25: CHMP meeting, Request extension of time (+3-months) for response to Day 120 LoQ, March 26
- October 9*: Response to Day 120 list of questions (LoQ), March 26
- December 10: Day 180 Opinion / recommendation of approval by EMA (if no more issue) or List of Outstanding Issues (LoOI)
- February 15: Commission Decision / formal approval (based on Day 180 Opinion by EMA, December 10)
- March 25: CHMP meeting, Request extension of time (+3-months) for response to Day 180 LoOI, December 10
- June 22*: Response to Day 180 LoOI, December 10
- July 22: Day 210 Opinion by EMA / recommendation of approval
- September 27: Commission Decision / formal approval (based on Day 210 Opinion by EMA, July 22)
g-
H-
See my recent post ( #280973 )
At least two (three) docs (from the USPTO) is available:
- 2-16-cv-02525-MMD-NJK - Doc 89 - Exhibit 27
- 2-16-cv-02525-MMD-NJK - Doc 262 - Exhibit 18
Meanwhile ... I waiting patiently for the quote by eightisenough ... the relevant part of the Order (about USPTO PFO) that says: LDL-C and/or Apo-B effect is/are PFO acc. to the USPTO ...
Best,
G
20-1723 Appeal (& 216-cv-02525-MMD-NJK)
CalMustang: Please replace my previous post, sticky this one. Thx.
(Relevant) UPDATE: below
Appellant: Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited (AMRN)
Appellee:
- West-Ward Pharmaceuticals International Limited (n/k/a Hikma Pharmaceuticals International Limited) and Hikma Pharmaceuticals USA Inc. (Hikma)
-Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories, Ltd. (Reddy)
CAFC; 20-1723 Appeal Available documents #:
4: DOCKETING STATEMENT (AMRN)
8: UNOPPOSED MOTION TO EXPEDITE BRIEFING AND ORAL ARGUMENT
13: DOCKETING STATEMENT (Hikma)
23: DOCKETING STATEMENT (Reddy)
30: APPELLANTS’ OPENING BRIEF
31: NOTICE OF CORRECTION OF APPELLANTS’ OPENING BRIEF
32: APPELLANTS’ CORRECTED OPENING BRIEF
33: ORDER]
34: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
35: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
36: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
37: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
38: ENTRY OF APPEARANCE / Aimed Alliance / Amicus curiae
39: BRIEF OF THE BIOTECHNOLOGY INNOVATION ORGANIZATION AS AMICUS CURIAE IN SUPPORT OF NEITHER PARTY
40: CERTIFICATE OF INTEREST / Aimed Alliance
43: BRIEF OF AIMED ALLIANCE AS AMICUS CURIAE IN SUPPORT OF APPELLANTS
44: NOTICE OF NON-COMPLIANCE (AIMED ALLIANCE)
47: CERTIFICATE OF INTEREST (Reddy)
49: BRIEF FOR DEFENDANTS-APPELLEES
DC; 216-cv-02525-MMD-NJK Available documents
Best,
G
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Settlement ... management attitude ... etc.
If you have a car (Vascepa) parking at the front of your house ... you think it worth $500k (valid patents) and somebody offers $250k (Generics' settlement proposal): will you wait for the next offer (DC Order) or not?
Next day, somebody drives her/his car into your parking car (DC Order) and your car worth $100k now ... Were you incompetent? Were you stupid?
But no (real) problem, the insurance Co (CAFC) will pay you ... and the repaired car could be sold for $499.999k
Best,
G
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That's my take in this case.
N-
A hypothetical example illustrates how FDA determines whether forfeiture has occurred under the “failure to market” provision. For the purposes of evaluating item (aa), presume that on June 1, 2009, the applicant for ANDA A submitted its substantially complete application containing a paragraph IV certification, which it lawfully maintained. FDA approved the ANDA on December 20, 2012, and the 75-day period identified in subitem (AA) of this forfeiture provision ended on March 4, 2013. Thirty months after the date the ANDA is submitted was December 1, 2011 (the date identified in subitem (BB)).
The relevant date for item (aa) of the forfeiture analysis is December 1, 2011, the earlier of these two dates.
For the second part of the analysis under item (bb), presume that on January 1, 2013, a court entered a final decision (from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken) that the relevant patent is invalid and not infringed in an infringement action against a subsequent applicant for this RLD whose ANDA received tentative approval at some point before FDA makes the forfeiture determination. The relevant forfeiture date for ANDA A pursuant to subitem (AA) is March 17, 2013, 75 days after the date on which the court issued its decision. Notably, this date applies even though ANDA A in this example was not the subject of the litigation.
In this scenario, the failure to market forfeiture provision requires the first applicant to market by March 17, 2013, the later of the dates applicable under item (aa) (December 1, 2011) and item (bb) (March 17, 2013). In this example, if ANDA A applicant did not begin commercial marketing until after March 17, 2013, it would forfeit its exclusivity.
Hikma has to market (to get 180-day excluvity) on or before the 75th day after CAFC decision.
+ Q15 and Q16
Guidance for Industry, 180-Day Exclusivity: Questions and Answers
Best,
G
N-
About exclusivity.
FDA ANDA approval comes - sometimes - during the 180 days, when the clock is running (due to court decision) already.
Best,
G
g-
The FDA approval does not trigger a 180-day period. It is
a.) market launch or
b.) court decision
IIRC there is other condition also ... launch within 180 day after approval
Best,
G
ps.: Please note I did not fully DD the topic and the DD was weeks ago. I do not see it as a material issue / topic
B-
earliest: recommendation for approval by EMA by end of June ... approval by the EU by late August / early September (if Amarin answered the 120-day letter before end of April and no Phase 3 process)
"standard"#1: recommendation for approval by EMA by end of September ... approval by the EU by late November / early December (if Amarin will answer the 120-day letter before end of June and no Phase 3 process)
"standard"#2: recommendation for approval by EMA by end of January 2021 ... approval by the EU by late March / early April (if Amarin will answer the 120-day letter before end of June and Day-180 letter before end of December and Phase 3 will exist)
latest: recommendation for approval by EMA by end of June 2021 ... approval by the EU by late August / early September (if Amarin request extension of time - to reply - in Phase 2 and Phase 3 also and Phase 3 will exist
risk: after US and Canada approval ... 0.000000%. It is a question of when only.
Best,
G
I stopped to (closely) follow or project script# years ago ... (just like stopped P&L, BS, CF - long-term - projections). These are not relevant for me since beginning of 2018.
Don't worry ... you were correct (Typo on my side).
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