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Re: JRIII post# 181544

Saturday, 07/07/2018 12:24:07 PM

Saturday, July 07, 2018 12:24:07 PM

Post# of 693233
I agree that they should data lock by August, but I also think it is the thinking of many the refreshes are poorly named and are more accurately called data collections. It appears at some point, hopefully the current data collection, it will be used/converted toward final data lock. Other than indirectly via the NICE timeline (which points to August 2018), since giving guidance to unblind at 233 OS back in the summer of 2017, NWBO has thereafter been intentionally noncommittal regarding their parameters for unblinding. Dr. Bosch now states (after previously committing to 233) it has to do with event rate, but he won't share that rate. LP now apparently has a less scientific view that she wants to enter the Guinness Book of World Records for fat tails, even though the km tail will be drawn by the end of this latest data collection. Management have presently gone missing in their guidance.

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.

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