Replies to post #40483 on Amarin Corp Plc (AMRN)

[Whalatane]

Montana

Do not think Reduce It will be stopped in 2015
Do not think there will be 40-50% efficacy
Do think that dietary supplements will always be a challenge unless insurance co pays or tier rating make price lower then $60 a month .
Do think there will be surprises in 2015 as Amarin works out financing to cover co to late 2016....AND..interest ramps up towards year end 2015

Sorry my writing was so confusing ...put it down to max dose Statins ( or red wine or combination of both :)

OT ...the Imitation Game ...great movie for history , puzzle buffs ...or anyone that enjoys a good story and great acting ....even you HD ...no headmaster "off topic " lectures please

Kiwi

[HDGabor]

(I think) The trial will be stopped based on interim analysis, however the interim analysis will be in 2016 (not in 2015).

Safety side: it's fine, the DMC review the safety data on a quarterly basis and they gave a the thumbs-up every time

Efficacy: "is blind to that committee [DMC] and to ourselves [Amarin], other than whatever they [DMC] might interpret based upon the safety." (Q3's CC)

So interim analysis will be done at / after 967th event, and it is expected (by me) in Jan/ Feb 2016, as:
- after the event, the statisticians will prepare the analysis (meanwhile DMC & AMRN are still blinded).
- 2 months after the 967th event the analysis will be delivered to the DMC, meanwhile AMRN is still blinded (Note: 2 months is just my guess, if anybody has a more exact knowledge about the possible duration of the analysis let me/us know)
- if the result meet with the stopping rule, the DMC will recommend the early stop to AMRN (I guess it is still blinded to AMRN)
- AMRN will decide to accept the recommendation or not. If yes, the study will be unblided to AMRN also.

Based on that the "100% of the targeted events currently anticipated to occur by the end of 2017" (Q4) I expect 23-31% eff. and it will be enough for early stop. >19.5% required for p-value <0.001 and/or 25% for 99% power ((c) data by Biwatch)