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Message: Re: Shrinking MACE event rate
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Jan 21, 2019 10:44AM

"So late entries past June 2018 will continue dosing until June 2019 and so on. We have been told however that dosing continued past Dec 2018. So will late entries be counted in the overall scheme of things, hence causing a delay in the reporting of the data?"

Koo that is old news that must be forgotten and revised with updated company guidance. Originally, dosing would be limited to 104 weeks such that first patients enrolled would reach 104 weeks and stop and last patients in would go for at least 52 weeks....giving average dosing period of 18 months. That is old, outdated news. Actual enrollment rates were much slower than originally anticipated. Dosing period was changed to allow all patients to continue on drug until end of trial. The patients that started in November 2015 are now at 38 months dosing (assuming they are still alive). The 1 year minimum no longer applies according to the latest trial design update in the AHA 2018 poster and Sept 2018 AGM (see the unofficial AGM transcript that Imtesty provided). Now it is a 6 month minimum. All patients in BETonMACE have now been in trial for over 6 months so that is no longer a barrier. Since enrollment surpassed 2400 back on 3/19/18, and final enrollment was 2425 according to the 8th DSMB report, this means that all patients except maybe the handful of lagging China enrollment (that finished in June 2018) have surpassed 10 months of dosing as of today. 

BearDownAZ

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