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Wednesday, August 24, 2016 8:20:41 AM
Don't kid yourself, AMRN's attorneys are controlling every word written or spoken, the main emphasis of which has been to under promise in terms of results and time frames.
As for the extra events, I personally don't know how the process works and neither do you, but in my opinion, it will not reflect well on the perception of trial results (if halted) if it is discovered that they intended to intentionally "stretch" the interim out as long as possible to reach their target. As I understand it, once 60% is reached, those cases are analysed for the interim look. If there are other events during the time period of the analysis and if the trial is halted, then those additional events will be included in the final analysis of the trial. But they won't impact the IA recommendation.
I'm sure that if the attorneys are guarding every word, then they are certainly advising them to precisely follow procedure - absent of telling the DMC what to do.
All that being said, I agree with Isaeed's post, we will have news sometime in the next 3 weeks and the drug will have to show efficacy on 60% of the total events in order to be halted.
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