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Message: Re: Countdown

Jul 07, 2017 11:25AM
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Jul 07, 2017 11:40AM

As for the timing of the AGM.......When I asked last year about timing requirements of the company between the Notice of Meeting, Record Date, and Meeting Date, this is what Sarah responded:

"The Notice of Meeting must be filed at least 25 days before the Record Date, and the Record Date must be between 40 and 50 days before the Meeting Date. A new Record Date will be set. The date of this year’s meeting need not necessarily affect the date of next year’s meeting."

So the AGM could still happen in September 2017 if the notice of meeting is filed in time. 

Regarding Hartland's question about the DSMB analyses, they are unblinded when they look at the MACE events at the futility analysis and will know who is apabetalone or placebo. I believe they have been unblinded at each of the four interim safety analyses, since the point is to determine if apabetalone is eliciting any adverse events or side effects with increased frequency relative to placebo.

You asked hypothetically what if there were 70 MACE events right now with 35 in each group. I don't think that the DSMB would stop the trial based on equal number of events in each group with only 70 total MACE events. However, if there are approximately equal number of events in each group at the 125 event futility analysis, then this would very likely lead to a recommendation to stop the trial based on futility. 

That would be a shocker based on all of the insights from the post hoc analyses of SUSTAIN and ASSURE, as well as the additional clinical/research insights that have occurred in the past couple of years. We will find out soon enough though with the futility analysis expected sometime in the next few months. 

BearDownAZ 


Jul 08, 2017 06:47AM
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