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Sunday, August 13, 2017 4:40:20 PM
But I'm operating as if January 2017 is when they reached 248 because they PR'd it in the first week of February.
I will add this:
Remember when they changed the date on clinical trials.gov from September 2016 to November 2016? That was the date they expected to hit the primary endpoint - which of course is PFS, not OS. I personally don't think that they would move that date further out, knowing they had already reached it. If they'd not changed it in October, perhaps they could have argued that clinical trials was simply not being updated - that they were too understaffed to do it. But to come in and change the date to November indicates that it was being updated. In fact, all of the trial sites were being updated to their formal, full names at that time as well. So to update all the site names, and move the date forward for the primary endpoint to November 2016 argues that this is the month they expected to reach it. If they had reached many, or really any, months earlier, doesn't seem like something they would do.
So given that, I'm operating on the fact that these lawyers were not playing cute with material information like that.
Still... if they really did reach 248 at a much earlier time, using just averages, the numbers I was working with give the trial plenty of months to spare. For example, if they reached 248 in say September 2016 (which is the time the clinical trials was indicating they would hit the primary endpoint) instead of that 23 months later, it would have been 18 months. So the numbers might look more like this:
82 control x 9 months (and I think that's high for control patients) = 738
165 treatment patients x 23 months (instead of 30) = 3795
738 + 3795 = 4533 / 248 = 18.27 months
Still, averages are not medians. But for someone like me, who is limited by my understanding of the algorithms used to model these trials, I'd think using averages is the next best thing.
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