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Message: Re: Dosing to end of trial
4
Jan 21, 2019 01:55PM
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Jan 21, 2019 02:41PM
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Jan 21, 2019 04:01PM

"Could it be announced that they will extend things even further and try to reach 300 MACE events?  I don't know.  I think it is a possibility, although somewhat remote imo.  I think even Bear inferred this possibility a few weeks ago.  He didn't get much in terms of response to that assertion though.  Maybe it was too shocking."

My understanding is that the first 250 events are the "on-treatment"events. Once BETonMACE reaches 250 events, dosing stops and the adjudication and safety follow up period begins. Events that happen during this adjudication and safety follow up period are "off-treatment" events. Whereas the end of dosing is event driven by the first 250 "on-treatment" events, the number of "off-treatment" events is arbitrary and accrue until the adjudication of the first 250 is complete. From my understanding, the primary outcome analysis is only dependent on the 250 "on-treatment" events. So anything above 250 is irrelevant, in my opinion, other than to inform how quickly the beneficial effects of apabetalone wear off.

BearDownAZ

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