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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 ...
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Not likely.
Best,
G
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Read my post again ...
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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
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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
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You are spot on.
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G
European Commission’s decision to grant marketing authorization = EU approval
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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 ...
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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
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Thx.
As JT said (Fireside Chat with Piper Sandler on Dec 4, 2020):
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Monday, 11/30/20 05:42:31 AM
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G
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m- & circuitcity #312176 (& Martinko #312175)
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I deleted all of my Amarin related files, so my posts are based on my memory. However Google is our friend ...
BENCH ORDER
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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%.
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- 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
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