Amarin Corp Plc (AMRN)

[HDGabor]

zumantu,

"Amarin can get trending info on R-It" and "maintain the blinding integrity" could not happen together, they are opposite. I am not 100% sure: The data will be still blinded for Amarin at the time of DMC's recommendation (stop the study) and they will get it if they agree and stop the study, otherwise (continue the study) it could be biased.

Amarin could do the following steps regarding ANCHOR:

a.) try to agree with FDA about second, earlier interim analysis ie.: at 50% / 805 events, we need at least 20,75% eff. for 90% power. (with 25% eff. it will be around July 2015)

b.) it's not mine (cited by louieblouie #34191), but a good idea: submit the ANCHOR sNDA as accelerated approval under subpart (h), or if possible (?) change the type of the current submission

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birzinho,

I did not take anything personally, my posts qualify me. Yes, sometimes I am wrong, but I have a logic always. The current situation at least is not good (I am a long also), however we could not ignore the facts to confirm our expectations. JJ will not wake-up on Monday as "Oh, Jesus, I would like to wrote "reinstatement" and not "uphold".

MLK weekend was about the negotiation (if any) and not about "I have a dream ..."

Do not expect anything from NCE case regarding ANCHOR SPA, since the two items are not related legally. The NCE ruling (my view: will be in favor of AMRN) will not change anything regarding the SPA issue. ANCHOR could be approved as b.) above only under the current circumstances.

To be more precise: DMEP could approve the sNDA without SPA, however they rescinded it as they have to approve it with SPA (after the successful study), so I do not think they will. The best: data will be included on the label.