Saturday, July 07, 2018 12:24:07 PM
Here is the history.
1. Efficacy interim supposed to occur early 2014.
Excuse: The trial was resized August 2014.
2. "Topline" (trial completion) was supposed to be reached early 2016.
Excuse: Screening halt in August 2015 prevented last 17 patients from being enrolled.
3. Trial completion was suppose to occur November 2016.
Excuse: By December 2016, they suddenly wanted to unblind OS simultaneously with PFS.
4. Unblinding was suppose to occur July 2017 at 233 OS events.
Excuse: They really didn't mean it -- according to comments in January 2018.
5. Indirectly, NWBO's guidance to NICE points timeline regarding data deadline for appraisal by August 2018).
Preexcuse? Unblinding occurs when tails are the proper secret thickness and the event rate hits an undisclosed secret number.
Respect Risk. Conduct Your Own Due Diligence. Manage your assets wisely. Diversify.
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