Amarin Corp Plc (AMRN)

[HDGabor]

I found it on YMB:

"I received this email today from the group conducted this study:

I am able to let you know that the paper has now been accepted by a major journal so the next stage is the checking of the proofs when they arrive, etc.
Again this process can take some time and we are unable to predict how long this will take.
Thank you again for your continued interest and patience, I hope to have more positive news for you by the middle of July."

BioChica: yes, the DMC are the only ones that have access to interim data DETAILS. General number (ie.: enrollment data, events number, etc. – only as total and not separated by arms) are available for the sponsor.

Kiwi,

if that ends up being lower because of the aggressive Statin treatment to get LDL below 100 goal

My view that the 5,2% was determined based on that the patients are on statin, so I do not expect decrease due to statin use. (It could be lower (and higher) if the 5,2% assumption is wrong.)

Inclusion Criteria: On statin therapy for at least four weeks
Patients are excluded if using the following medications:
- niacin >200 mg/day or fibrates;
- any omega-3 fatty acid medications ;
- dietary supplements containing omega-3 fatty acids (e.g., flaxseed oil, fish oil, krill oil, or algal oil);
- bile acid sequestrants

Events:

Based on AdCom’s material and 10-Qs / CCs, we know the app. date and patients number. (The AC table contains 3/6/9/12/15/18 months)

2012.10.05. / 1 756 / 1 181 / 44 / 51


1 756: total enrollment till 2012.10.05.
1 181: 1756 - 575 (total enrollment till 2012.07.06)

51 = (1 181/2) x 0,052 x ((today-2012.10.05.) / 365)
41 = (1 181/2) x 0,052 x 0,85 x ((today-2012.10.05.) / 365)


Date / Total enroll / enroll of the period / event Vasc. / event placebo

2014.03.31. / 6 800 / 300 / 1 / 1
2013.12.31. / 6 500 / 425 / 4 / 5
2013.10.04. / 6 075 / 540 / 8 / 9
2013.07.05. / 5 535 / 1 084 / 22 / 26
2013.04.05. / 4 451 / 1 408 / 36 / 43
2013.01.04. / 3 043 / 1 287 / 40 / 48
2012.10.05. / 1 756 / 1 181 / 44 / 51
2012.07.06. / 575 / 467 / 20 / 23
2012.04.06. / 108 / 108 / 5 / 6
TOTAL / / 6 800 /181 /213
TOTAL(Vasc. + placebo) 394