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m-
I do not have a singe AMRN share.
What does your crystal ball tell you with regard to how this plays out for AMRN now that the US is lost?
Hikma wasn't the first to file a para IV cert ANDA, Teva was (4/22/2014)
O-
what do you believe is a realistic sale price would be for AMRN today assuming approval in the EU and no change with the status quo in the US?
what are some of the companies at the top?
(Relevant) Events:
Dancing in the dark: If you think, please replace my previous post (sticky) with this one but at least remove the existing sticky. Thx.
September
- September 14-17: Day 180 Opinion / recommendation of approval by EMA (if no more issue) or List of Outstanding Issues (LoOI)
November
- 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.)
January
- 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)
Best,
G
ps.:
(i) “shortest” EMA timetable in case of LoOI
- September 14-17: Day 180 List of Outstanding Issues (LoOI)
- October 13*: Response to Day 180 LoOI, September 17
- November 9-12: Day 210 Opinion by EMA / recommendation of approval
- January 15: Commission Decision / formal approval (based on Day 210 Opinion by EMA, November 12)
*clock restart
Notice: This post will not be updated anymore.
K-
1.) (I think) They could not make any agreement w/o the official approval / label. The best they can do: put together the "docket", make some "introduction" meetings ... but I do not think they will / have to do anything before the CHMP meeting in September.
2.) No overall standard, different on a country by country basis, however they could start to sell w/o an agreement (in some countries). e.g. Germany: the price could be determined by Amarin for the first 12 months, no agreement is required, V could be marketed ... but no reimbursement till agreement.
Any insight into API ( EPA ) supply agreements . Nisshu ? has a supply agreement with AMRN ( from memory ) but I believe Nisshu has declared they have excess capacity
My understanding is that Hikma/ Dr R will have 6 mths exclusivity once they launch ...but would expect Apotex to quickly follow
contrary to HDG's expectations
F-
You could be right ... I do not know ...
Best,
G
N-
Yep more Form 4s.
We see it since February and will see till August, 2021 … but (it is not a 2020 / recent award )
M-
LoOI???
j-
U think we can see EMA recommendation 9/14-9/17
F-
Now this week Vascepa is on the agenda of the EMA´s Pharmacovigilance Risk Assessment Committee (PRAC)
M-
Same.
I am still see as:
- the mix of the judges is not important as seen by others (due to the type of the mistakes by Judge Du ... especially: did not defer to the USPTO and [lack of some] SCs support Defendants)
- prima facie obviousness is true for TG lowering but not for Apo-B and LDL part was not clear and convincing by the Defendants
- not two but three SCs exist
Best,
G
s-
Do you think they allowed the trial to progress more for the safety factors than efficacy?
Stopping for overwhelming efficacy was discussed at each IA; prior to IA study continuation recommendations, the DMC considered historical examples of failed CV outcome studies for TG-lowering and mixed omega-3 therapies, reflected on the potential for overestimating final demonstrated benefit using incomplete data, and weighed societal impacts of fuller datasets relative to patient therapy access.
W-
is generic Vascepa also considered as the "product" here
W-
I am still not very clear whether the exclusivity is applied to the product or the company.
W-
Can you please elaborate on the "regulatory exclusivity" definition? Does it mean that only one company (i.e., Amarin) can sell pure EPA drug legally in the EU market? Or it's the exclusivity of the drug itself, i.e., pure EPA for the RIT indications regardless of which brand?
Medicinal products for human use which have been authorised in accordance with the provisions of this Regulation shall benefit from an eight-year period of data protection and a ten year period of marketing protection, in which connection the latter period shall be extended to a maximum of 11 years if, during the first eight years of those ten years, the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies.
I am not convinced that patents will be enough to protect Amarin in OUS IF this appeal is a loss for Amarin
J- (&Will Lar)
EU protection:
2021* - 2031**: 10*** years regulatory exclusivity
2031* - (IIRC) 2033/24: protection by patent(s)
* from date of the approval by EU Committee
** in case of new, approved indication: 2032
*** "breakdown" (IIRC): 8 yrs data protection (like in Canada) + 2 yrs market protection
Best,
G
H-
HDG has it right
j-
Read Amarin's Press Release closely...
H-
To be "devil" advocate ... How about:
2-3 million US people have VHTG but a small fraction (2-3%) are treated. We believe more people will be on gV over time ... it could be a 1bn or bigger (VHTG) market.
Best,
G
Will H enter the U.S. market with gV before, or after, mid-12/2022? Are you unaware of the statutory exclusivity that expires then?
it's funny that you still can't admit what you quoted doesn't include the word Hikma, either directly or parenthetically
not specific to "(Hikma)"
You come here pretending to be a legal expert
I am not (neither) ... It is so funny that you lecturing hayward meanwhile still do not understand Hikma's presentation (at JPM) ...
the existence of an estimate. That's s t a n d a r d. The entire issue was the scale of that estimate
M-
The reason everyone was jumping up and down during the JPM healthcare conference had nothing to do with the existence of an estimate. That's s t a n d a r d. The entire issue was the scale of that estimate. Let us know if you're still confused.
till the release of the Order
First, why is the release of the order taking so long? It is beyond the administrative excuse given to me by JT.
Wrong ... 20-1901 is 20-1723 are "the same"
The CAFC has NOT granted motion 11 yet and I don't think they will UNTIL fully briefed. This briefing will be completed independently from Oral arguments and likely will be scheduled to be decided on briefs alone as oral argument will cure most of the issues.
Appeal 2020-1723 & Appeal 2020-1901. This is the "original Du case" and the 2 Appeals where consolidated on 7-13.
Case: 20-1901; Document: 14-1; Filed: 06/26/2020
Case: 20-1723; Document: 57; Filed: 07/13/2020
j-
The SC's did not help prove differently EVEN THOUGHT THEY WERE WEIGHED AGAINST EACH OTHER AS IN OUR CASE
The truth is "between" the two ... Meanwhile the FDA review the commercial manufacturing process and site - small scale batches should be produced at the proposed commercial site, the primary batch information submitted in the application is used to support the proposed commercial product manufacture - commercial scale (quantity) should not be provided.
The FDA review of the commercial manufacturing process and site does not mean that the commercial site could produce commercial scale ... scale-up could be problematic.
o-
I believe the bond would be calculated(estimated) on the MARINE indication sales and not total expected sales...correct?
c-
What do you make of this unloading by BB? Is it related to regulation, no more than 10%?
We will see if cases get consolidated without further briefs...they might NOT get granted consolidation
p-
Baker Bros average price per share stated at $8.93.
Really?!
r (&louieblouie & circuitcity)
No Change for AMRN in terms of number of shares. You indicate that they sold over 23 million shares in Q2. Discrepancy?
Is not in the PACER ... yet
O R D E R
The parties in Appeal No. 2020-2108 move jointly to consolidate that appeal with Appeal No. 2020-1723. The motion is not opposed by any party in either appeal.
Appeal No. 2020-2108 is an appeal from a consent judgment predicated on the final judgment underlying Appeal No. 2020-1723. Appeal No. 2020-1723 is now fully briefed. The parties in Appeal No. 2020-2108 agree that no additional briefing is required, and the outcome will be controlled by the outcome of Appeal No. 2020-1723.
Upon consideration thereof,
IT IS ORDERED THAT:
(1) The motion is granted. Appeal Nos. 2020-1723 and 2020-2108 are consolidated, and the revised official cap-tion is reflected above. The consolidated appeals are fully briefed and ready for calendaring.
(2) A copy of this order and the motion papers shall be transmitted to the merits panel assigned to this case.
B-
Baker Brothers still holding over 34 million shares.
p-
As it is stated to consolidate only Hikma it looks as if Dr Reddys is being treated differently ie not consolidated.
z-
How much of this loan remains to be paid?