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BWIS

06/02/20 10:19 AM

#286784 RE: trocprofit #286780

Shouldn't soft lock have been done for 95% months or years ago?
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Sojourner55

06/02/20 10:23 AM

#286789 RE: trocprofit #286780

Agreed. If end points are met unequivocally then they might just issue a one liner and leave the analysis later.
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exwannabe

06/02/20 12:58 PM

#286835 RE: trocprofit #286780

The other "positive" in this PR is the comment that they may go "soft lock" if things are not moving as they hope.


Positive? That sounds fairly screwed up to me.

The hard lock refers to the lock for the formal analysis of the primary (and now all) endpoints.

A soft lock would imply this is not the start of the unblinded analysis.

And how much data can they possibly be missing by now? The clinical portion of the trial has been over for a while. The only data that has been subject to change is the telephone call survival follow-up.