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flipper44

01/21/17 8:39 AM

#97357 RE: vator #97353

I think LL (in her December 15 presentation) slightly corrected LG's and LP's explanation (from their December 8 PR) regarding the primary trial completion date, data lock and unblinding. She also basically halfway answered the question regarding event count by saying we haven't reached 248 as of December 15, 2016. In other words, the last details before data lock, I would then argue, are getting the PFS count accurate because, IMHO, with all the continuing submissions of information to the FDA, the other hard work required to that point has already been done by the CROs. I know that's not typically how it is done but it makes sense, and it aligns with LL's presentation which I interpret to say the primary trial completion date, data lock and unblinding will nearly be simultaneous. IMHO, that is why we are not getting the update in the form NWBO asked for.

In other words, the PR was discussing how things are typically done in most trials, and LL went slightly more granular as to how things are specifically done in this trial.

The count is the thing.