Sunday, May 03, 2020 5:49:08 AM
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)
Disclosure: I wrote this post myself, and it expresses my own opinions (IMHO). I am not receiving compensation for it.
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