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K-
Nope … it was about he has to apologize (he has to post more like this …)
Best,
G
ps.: if you SYH (#254456) you will be more confused
m-
The number of cases is just a symptom ... more likely (hopefully) the total number of deaths will not the exceed the number of deaths due to flu … but that is not a point. A lot of event (e.g. 09/11) had less death than the flu …. but it does not mean it was not serious.
I do not say it will but it could be "out of control" if will not be taken really seriously … unfortunately a lot of stupid (e.g. see beaches of Florida or the view by the "ass renovator") still downgrading the importance of it.
I could quote myself
Wednesday, 03/18/20 07:55:14 PM
Tuesday, 03/17/20 08:20:40 PM
r-
Figure 15. Primary and Secondary Composite Endpoints by Baseline Statin Medication Type: ITT Population (Page 123)
Table 19. Summary of LDL-C (Derived) (mg/dL) One Year Changes by Baseline Statin Medication Type
(Page 124)
Best,
G
o-
I do not see any reason for the delay … at least for the the 1st letter.
- it is an online process
- deadline is around the corner (March 26)
I expect the EMA letter as it should be: on or before March 26. The only question is the content:
- list of questions (more likely)
- Opinion … recommend the approval
Best,
G
This is the newest (updated).
Mod: Please replace the sticky. Thx.
(Relevant) Events in 2020:
March
- Day 120 Opinion by EMA (if no question ... target date: March 26)
- Trial decision
April
- Response to Day 120 list of questions on or before April 24 (TBC) … it is the earliest deadline after March 26 … Amarin will have three to six months to answer the list of questions
May
- (Week 19 … TBA): Q1 2020 (10-Q and CC)
Q2 Direct to consumer branded advertisement launch in U.S.
June
- Commission Decision (based on Day 120 Opinion by EMA on March 26, target date: June 1)
- Day 180 Opinion by EMA (if no more question ... target date: June 25)
- Response to Day 180 list of questions on or before June 30 (TBC) *
* Please note: used exceptionally and after agreement with the Rapporteurs when minor issues remain which allow the applicant to respond shortly after the CHMP list of questions and the Rapporteurs to assess the responses within a shortened assessment time.
July
- "Special" Day 210 Opinion by EMA (target date: July 23) *
August
- (Week 32 … TBA) Q2 2020 (10-Q and CC)
- Response to Day 180 list of questions on or before August 18 (TBC) … it is the earliest deadline after June 25 … Amarin will have one to three months to answer the list of questions.
- Commission Decision (based on Day 180 Opinion by EMA on Jun 25, target date: August 31)
September
- Day 210 Opinion by EMA (target date: September 17)
- Commission Decision (based on "Special" Day 210 Opinion by EMA on July 23, target date: September 28) *
November
- (Week 45 … TBA): Q3 2020 (10-Q and CC)
- Commission Decision (based on Day 210 Opinion by EMA on September 17, target date: November 23)
Q4 (TBC): Chinese MARINE trial result
Best,
G
Better to remain silent and be thought a fool than to speak out and remove all doubt. … you are not the best person to determine that TTE and me are "dumb and dumber" since you are clinched the remaining spot: the dumbest.
Sorry I am a real MD
lessons learned in Viet Nam
You both need to stick to what you know best
t-
I would rather see the number of new cases and the number of active cases.
B-
then make sure you’re first in line.
T-
Excellent.
We all know who is the dumbest … but I do not know: Is you or me the dumb (and the other the dumber).
Best,
G
US 5,927 cases may be well above 7000 tomorrow.
r-
The interest of humanity is bigger than the interest of the individual … furthermore you could afford it.
Best,
G
ps.: To avoid any doubt … I hate to pay any tax
s-
A lot of people are dying in a car accident … a lot of them did not fast the seat bells … but is not everybody - who did not fast the seat bells - is dying.
The problem:
- no seat bell
- you do not have to be in a car to dye
Best,
G
r-
would pay double in taxes. Enjoy.
s-
650,000 Americans die every year from cardiovascular disease. One person every 37 seconds. Where’s the fear and outrage?
K-
Thx.
Believe or not but Hungary (Europe) is not a 3rd World … (3.3 CV / 1M in Hungary) … we are fine, doing what should be done (school closed, no big gathering allowed - 100 internal / 500 external, etc.) … we - as every country - will be fine … but it depends on the individuals also (handle it as has to be handled in 2020 … it is not 1965 /1973 …).
e.g. I had a scheduled lunch for Monday but we cancelled it. It was not cancelled because we are panicking or fearing but all of us have elderly parents. That's all: take responsibility.
Best,
G
K-
FYI: I stand corrected but I think I was the first one (at least on this board) who pointed the REAL problem with this Tuesday, 03/10/20 07:31:25 PM
A lot of poster got it … but "somebody" replied like "Once upon a time in South Vietnam …" Ahhh … boring …
Best,
G
R-
What do you think the odds are we get a judgment this week?
JL-
But of course you know everything...
My point is a mask will not protect you from getting the disease
preventing you from spreading disease … new cases are contracted from people that are asymptomatic..And they don't know they should be locked up in a room
JL-
You should wear a face mask if you are infected..
s-
approximating 15 million flu infections and 600,000 related deaths, yet we don’t go on lockdown. Not trying to diminish this, bu Seriously, what gives?
I-
But they probably have not done this
Watching Television and Internet More Than Ever
g-
The only way to respect COVID 19 is to wear a face mask.
T-
Do they greet each other by licking each other’s eyeballs?
i-
Need DTC now more than ever.
Your view is short-sighted …
1.) & 2.): Temporary effect … minimal - if any - effect on valuation
3.) Virtual ACC will reach MORE people than the physical ... it will likely MORE effective
4.) No question, it has a preorder effect … but (more likely) "next phase" of co-pay had been reached nowadays also.
5.) We will see, but I do not be surprised if more patient will make visits …
"These marketing costs are for the moment fixed costs": Not exactly. Some are fixed (e.g. base salary of the reps) but a lot of are not (e.g. bonuses).
But to think that the spread of COVID19 and its affect on our society ...... is not relevant to AMRN ....will not affect Amarins ability to market Vascepa.... is IMHO plain wrong
there is a group, or hedge fund, or BP with a firm hand controlling this stock...
Lovasa scripts are still replacing Vascepa scrips at pharmacies..
Next week will be interesting …
Fabio Wajngarten -> Jair Bolsonaro -> who is next …?
Best,
G
t-
This country is in full blown panic mode right now
How many people are on the floor of the Nasdaq ...? Wouldn't it be nice if that shut down like the rest of the country?
L-
Do not be a pharisee … Do you pray for lower Gross Margin (lower price)? … More people could afford / will benefit, more folks could / will take it.
Best,
G
I-
I can only pray that Amarin wins her case. I just think of the thousands of people with cardiovascular disease that will benefit.
s-
This one (???) by KevGee59
Best,
G
J-
$20 per share hostile bid...great environment for it. The “arbs” would come in and take out all the frustrated shareholders. The reduced Baker Bros position no longer strategically significant. Would certainly put company in play.
I know exactly where to look