I’ll share some confirmation bias of my own. I would be happy to change this belief if anyone has factual evidence to the contrary of my theory.
I believe that hitting the OS milestone of 233 deaths while the trial is actively running would trigger moving towards data lock and would be a material event, thus requiring a PR. I also believe that the company is and has been truthful in their PR and 8k submissions at the time these were released. This includes the Feb 2017 PR stating they believed it would be several months before this OS trigger would be reached. Therefore, I believe that 233 was not reached prior to Nov 2018 statements by the company that they are moving towards data lock. So, allow me some simple math to support my theory that may be subject to confirmation bias related to these beliefs.
1) 12 LTFU patients per ASCO 2018 presentation
2) 28.2% KM derived 3 year survival presented in November after which company states they are moving towards data lock
331-12= 319*0.282=90 thus 90 patients had reached 3 year survival by October 2018. (That is how KM derived numbers work, people frequently forget about LTFU impact)
331 - 12 - 90 = 229
Therefore, I believe that fewer than 4 patients that reached 3 years had passed away by October cut off. As a result, I am convinced OS HR is positive, 3 year survival is positive and I have previously shared my belief that PFS was positive in AUG 2015.
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