Replies to post #82225 on Amarin Corp Plc (AMRN)

[mrmainstreet]

according to HDG there is ~ 7% chance of that happening.

[rafunrafun]

Pump much? Sure it's possible but highly unlikely - doctor follow-ups and data analysis in 10 weeks is incredibly optimistic. Then why release the news today about ANCHOR Ad Hoc study they'll talk about in a week? If that was the case, there would be nothing else to talk about other than RI.

[HDGabor]

F- (& marzan-)

I agree with you that the 6 months is the conservative expectations, it is the longer end of the time curve. However, I give 0% probability to "AMRN and management is planning to surprise us as early as tomorrow". The Jefferies presentation was organized weeks ago and announced on June 1. AMRN won't wait a "second - PR the dial-in number for the public -" at the time the DMC will 'calling" them with the recommendation.

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m-

You are mixing Jefferies 2016 Global Healthcare Conference (tomorrow, general company update) with American Diabetes Association's 76th Scientific Sessions (June 11-13, prsentation of "Effects ofIcosapent Ethyl on...")

FDA has done a 180 degree reversal in NCE

Not exactly, max 45 degree. They did not used the "active ingredient" approach, but revised ingredient / moiety analysis(1 to 1 instead of 1 to many regarding AI - AM relation) during the new determination, resulted in NCE.

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Best,
G

[sts66]

Is there a possibility the DMC has had ample time to gather/analyze what they need to in order to make a determination – especially if all secondary end points were met with overwhelming efficacy?

No way - they may not even be done with follow up visits with all patients yet. Secondary and subgroup analysis will slow down things quite a bit as well - can't automate everything, and in the end a real human has to look at results and see if they appear valid or if something odd pops out.

Case in point (not a drug trial, but similar enough to count) - I had thermal analysts that developed computer models of my systems to predict performance under different operating conditions. After a couple weeks of work one of them came to me with her results - the second I laid eyes on them I knew her model was way off somewhere, data literally violated some laws of thermodynamics - she had no clue how wrong the results were because she wasn't trained in the physics (more like biostats in AMRN's case), only knew how to create models and run the programs we used. This was not an isolated situation, it occurred with many analysts until they actually learned how the systems worked so they could realize when they were getting garbage out.