I have been saying for years that I didn't think they would unblind the trial UNTIL the OS endpoint was reached. I haven't changed my position on that. There is no me twisting of my own words. I know what I mean and then go through lengths trying to clear it up when someone doesn't follow what I'm saying.
Anyway, I make a statement that I believe that they made it clear that it OS need not be at exactly at 233 events before they unblind, and you then interpret what I mean that I believe they are going to keep collecting events similar to what they did on PFS. And that is not at all what I meant at all.
Having the option to postpone data lock and doing it are two different things. I believe that their intention all along is to unblind and review the data once the trial crosses the OS endpoint. But when they learn it's at 233 events it could mean that the trial is actually at 235 or more events. DMC is not getting the data in real time. The DMC are getting their data from updates from two CRO monthly reports (US CRO and EU CRO). The CROs can be, but are not always, getting event site data in real time (from eCFR). Sometimes the eCFR does not have the death data yet on the patient but the patient is in fact dead (patients are on two month schedule and if they die between visits and it is not learned until follow-up period that constitutes a late recording of a death event in a CRO report (meaning perhaps a patient death in June does not make into an eCFR until July/August during a follow-up inquiry period)). And thus if the CRO is getting real time eCFR, then the DMC isn't getting real time event data, and then the company is finding out later too. That's how I interpreted Bosch's to mean by that slide -- it could be 233 or more that OS endpoint is breached. And so I still believe the plan is to unblind once OS is reached. BUT, I didn't just interpret his comments to mean the trial will end at OS, once they learn 233 or more events were crossed. I believe he bought the Company the option to delay OS if they so choose, and by that slide, we essentially were told that OS endpoint can be data locked late.
I perceive that when that OS endpoint is triggered, depending on when it comes in, it could cause a decision scenario to temporarily postpone the data lock. And I do believe that Bosch's slide point "of minimum of 233 events are needed to unblind the trial" also covers the possible scenario of them letting us know that they can, if they so choose, at the time OS is reached, to temporarily delay the overall trial data lock. Again, I believe they plan to end the study once OS endpoint is reached. And I believe Bosch vocalized that plan. But I certainly believe by that "minimum of 233 OS event" slide, the Company disclosed to us that the trial can run longer if they deem its necessary once OS endpoint is reached. They like options, and they have option to delay ending the study should they decide it makes sense to continue to collect OS events, for whatever reason.
Moving on. To be clear, you didn't say that they don't have the option to continue to collect OS events after knowing that OS endpoint has been crossed. I didn't mean to imply that you disagreed with me that they can data lock late if they so choose. It's not how I wanted that paragraph to be interpreted at all. I only meant if you somehow decided you disagreed with with my viewpoint (of them having the right to data lock late, should they decide to do so) on that point then I would agree that you found something that you disagreed with me on. Seems you agree with me that they have the option to data lock late, should they chose to exercise it, and so we don't disagree on either point.
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