Thursday, June 22, 2017 9:39:45 PM
The DMC, in my humble opinion, won't know until sometime in July, whether June events breeches 233 events. It doesn't mean that all deaths at this stage be recorded real time. But there is always a chance that it can be delayed recording of events. The company told us that they expect 2 deaths in early July, based on the rate, it can be July, August or later that that death data gets recorded and passed along to the DMC lead.
The two CRO reports together have to equal 233 death. Does the CRO report it the begin, middle or the end of the month? We don't know. But we do know according to the protocol, there is a monthly report that the DMC receives. It is going to come down to when the death information reaches the CRO (whether it's real time receipt or it's their part of their own follow-up or not) and whether the information is contained with the DMC monthly report.
But, we'll find out soon enough.
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