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flipper44

06/25/19 7:16 AM

#234461 RE: marzan #234460

First. Dr. Bosch stated almost two months ago stated that the data that would be included in the data lock would be data up to that point (up to that that point = just prior to hard data lock). That is a clear indication that the trial will use event data up to that point -- perhaps only OS is still being officially collected/confimred.

Second. No one here. No one has proven that David Innes confirmed soft lock occurred in January. Hopeforthefuture states that David Innes seemed to indicate it already happened but DI will not confirm when it happened. Senti is saying it is confirmed as "January," but she has offered no proof. None.

Third. Even if a "SOFT" data lock has occurred, data can still be "updated," according to various articles out there. However, a "soft" data lock means all queries have already been resolved. Not all queries were resolved when Dr. Bosch spoke in June.

Fourth: Whether soft lock has occurred or not, it does not mean the data cannot be updated -- according to various articles. It can be, but the update would be restricted to the lead data manager making updates.

Fifth: Therefore, because Dr. Bosch states (on the record) the data used in the final data lock will include data up to the (hard) data lock, then regardless if there has been a "soft" data lock or not, the lead data manager must have the ability to "update" the number of overall survival events -- otherwise known as a "sweep" according to various articles -- unless Dr. Bosch miscommunicated.