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EU approval
The letter is written, signed, enveloped (EMA Opinion) ... but the Post Office (EU Commission) has to deliver.
The EU Commission has (the EMA does not have) the right to issue a legally binding authorization. It is a formality only, the official / legal process ...
l-
where can I find the previous terms of executive severance and change of control plan you mentioned
This Plan was adopted following recommendations from Amarin’s independent compensation consultant with the intention of aligning these provisions with those of Amarin’s peer companies.
j-
Not likely.
Best,
G
This Plan replaces Amarin’s prior executive severance and change of control plan
d-
Read my post again ...
This Registration Statement will in essence beyond March 1, 2020 become a replacement for that expiring registration statement.
Keep in mind that the shelve registration is due to be updated. I believe in order for amarin to keep the shelve active they must file before feb. 26. If they don't file that would be the best news we could hope for.
As of the date of this Registration statement, Amarin is currently eligible to offer securities under its Registration Statement on Form
S-3 filed with the Securities and Exchange Commission on March 1, 2017 and automatically effective upon filing, or the Existing S-3. The Existing S-3 will expire and no longer be available for use by Amarin on March 1, 2020. This Registration Statement will in essence beyond March 1, 2020 become a replacement for that expiring registration statement.
I-
I take that to mean you have lost all confidence in Amarin Management and Amarin's future in Europe & other countries?
R-
Nope. I sold @6.49 in April ... but let the money works (e.g. EVFM: 5.00->7.50), so I am fine below $9.75.
Best,
G
It will take a long time
N-
I do not saying BO is not possible. All I am saying it does not looks like as imminent.
Fair to assume that any potential buyer will be in the pharma business ... more likely with existing EU operation.
If anybody approached Amarin and the discussion is in the late stage Amarin did not set-up EU operation.
Best,
G
Visa would buy Plaid as part of an effort by the card giant to tap into consumers’ growing use of financial-technology apps and noncard payments.
You are right if the potential buyer of Amarin has the same aim ... is not familiar / operating in this business (or does not have European operation).
Or it is the same as with Visa & Plaid ... Amarin and the potential buyer called off, terminated their deal ...
Plan B and real actions are two different things ... you implement Plan B if Plan A failed.
I am not 100% sure I got your message but:
a.) Lowball offer is not a (real) business practice. Usually the buyer offer less than it would like to pay and the seller ask higher than it would like to accept ... however the difference is not 50%. Both party has a realistic valuation and if the action is real they will agree finally ... or a potential buyer will make a public offer.
b.) If it is a rejection of a lowball offer it means: one interested party only and it sees the value as minimal ...
No ... the opposite. It is not a chicken game ...
a.) If you have a real interest / approach for a BO you do not set-up HQ or hire staff
b.) If you set-up HQ and hire staff meanwhile somebody approached you really interested in a BO, it suggest you do not take it seriously
M-
Do you care to speculate?
r-
You are spot on.
Best,
G
European Commission’s decision to grant marketing authorization = EU approval
i-
EU: EMA Opinion by January 2021, Committee approval by March 2021
China: Q4 2021 (but 2022 is more likely)
Best,
G
I took the Russian vaccine. It is working, no side effect, s etim vse v poryadke ...
z-
find an attorney willing to do this on contingency
i-
I do not have any Amarin docs anymore, but IIRC:
Hikma: Sep 27, 2016,
Dr. R: Sep 29, 216
Teva: Oct 10, 2016
The three complaints (files by Amarin ... more likely Doc 1 in every cases) contain the exact dates.
UPDATE (I googled):
Sorry, my memory was not precise
Hikma: September 21, 2016
Upon information and belief, on or before September 21, 2016, Defendants, through Roxane, submitted to FDA an ANDA (ANDA No. 209457) with paragraph IV certifications under section 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 355(j)(2)(A)(vii)(IV), for 1g icosapent ethyl capsules purportedly bioequivalent to VASCEPA®.
Dr. Reddy: September 22, 2016
Upon information and belief, on or before September 22, 2016, Defendants, through Dr. Reddy’s Laboratories, Inc., submitted to FDA an ANDA (ANDA No. 209499) with paragraph IV certifications under section 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 355(j)(2)(A)(vii)(IV), for 1g icosapent ethyl capsules purportedly bioequivalent to VASCEPA®.
Teva: October 7, 2016
Upon information and belief, on or before October 7, 2016, Defendants submitted to FDA an ANDA (ANDA No. 209525) with paragraph IV certifications under section 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 355(j)(2)(A)(vii)(IV), for 1g icosapent ethyl capsules purportedly bioequivalent to VASCEPA®.
Best,
G
W-
Thx.
As JT said (Fireside Chat with Piper Sandler on Dec 4, 2020):
So, in Germany, we’ll start early in 2021, putting some feet on the ground doing pre-approval introductions, education, focused in on cardiology, try to increase awareness of VASCEPA. Again, leading medical societies are already there. But focusing in on the cardiologist, they wouldn't surprise me if by the end of 2021 would launch in Germany that we had over 100 people on the street in Germany as being the largest market.
F-
You don´t need sales reps in Germany, Austria and Switzerland and most other EU countries, because you aren´t allowed to promote a drug for which you need a receipt.
M-
Monday, 11/30/20 05:42:31 AM
Best,
G
a-
Why are you still here??
If the stock is just going to be range bound $4-5.30 till at least Q121. Doesn’t add up to me..
d-
they could sue Hikma for infringement. They can also file for an injunction.
c-
Are they idiots in your minds?
I understand none of our speculation matters.
C-
does this contribute to the "Non-Infringing Uses" argument?
m- & circuitcity #312176 (& Martinko #312175)
what do you think the best plan of action would be with regard to the US market if you were steering the AMRN ship?
can you speculate why amrn still doing marketing?
Did you study law and health care in US
did you live there?
N-
(a) person is liable as an aider or abetter so long as they provide any successful assistance to the wrongful act, regardless of how exactly they provide that assistance
Remember if Amarin files an infringement suit it will not be a Hatch Waxman suit.
H-
a substantial (volume implied) use burgeons in excess of any possible real-world demand for that limited skinny label indication. The facts then are that generics are enabling an infringement by proxy.
The district court applied an incorrect legal standard, for precedent makes clear that when the provider of an identical product knows of and markets the same product for intended direct infringing activity, the criteria of induced infringement are met.
There was ample record evidence of promotional materials, press releases, product catalogs, the FDA labels, and testimony of witnesses from both sides, to support the jury verdict of inducement to infringe the designated claims for the period of the ’000 reissue patent.
If SCOTUS were to rule on this definitively we would be well served
the skinny label here really is very skinny and the carved out portion so fat
So in order to cover drug-drug interaction warnings etc, the FDA felt that the CHF label in entirety should also be incorporated into the skinny label unleashing a Pandora's box of complications.
N-
I deleted all of my Amarin related files, so my posts are based on my memory. However Google is our friend ...
BENCH ORDER
We do still disagree on the meaning of the GSK v Teva ruling.
C-
Does this mean that a new GV prescription is OK, but Refills are Induced Infringement (by label)??
C-
a.) I am not sure that all "condition" (are not unusual, far-fetched, impractical, occasional, aberrant, or experimental) have to be met.
b.)
(i) MARINE indication for less than 12 weeks / for more than 12 weeks
(ii) MARINE indication / R-IT indication
As MARINE indication for less than 12 weeks was judged as substantial (are not unusual, far-fetched, impractical, occasional, aberrant, or experimental) it is more likely the FULL (less than and at least 12 weeks) MARINE indication will be judged the same way.
c.) VHTG indication, use is independent from Amarin / Vascepa. It existed before Vascepa ... are not unusual, far-fetched, impractical, occasional, aberrant, or experimental
d.) Meanwhile off-label use (pre Dec 2019 or pre Sep 2018) existed - more likely the majority was MARINE use (especially before Sep 2018). It is still (Q1 2020) more than 10%.
To me there's a very good case for induced infringement
N-
- gV's label promote, encourage MARINE indication, use (for any period)
- Amarin's patents cover MARINE indication, use for at least 12 weeks
(i) generic are liable for induced (by label) infringement of Amarin's patents ... the use at least 12 wweks
(ii) generic are NOT liable for contributory infringement of Amarin's patents because substantial, non-infringing use (MARINE indication, use for less than 12 weeks) exist
Best,
G
t-
Because they are not allowed to reference R-IT label.