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Re: Rkmatters post# 71652

Monday, 08/29/2016 9:40:47 AM

Monday, August 29, 2016 9:40:47 AM

Post# of 730784
You didn't prove anything but that you extend too far in drawing conclusions :) The re-size was obviously due to BSSR procedure. 192 randomized by early 2014 is logical. 32 with "confirmed" psPD applying the strict criteria in protocol is also reasonable. They assumed by the time 240 were randomized they would have found 48 (from about 72 "suspected" psPD). They found less. That's all. It was always a rough estimate.

There may have been a case for thinking the sample increase was "other" related, even though that reasoning was mostly spurious, but once we learned the trial was on pause for a bit as IRBs approved changes, and learned 300 were randomized Aug 2015, the 192 early 2014 made much sense.

Also, the CEO at a conference in March 2014 was talking all about how to trial was designed with this feature to increase sample size to increase powering, calling it a "wonderful feature" and that it would "de risk" the trial. Obviously the BSSR. Why did she bring it up just then? ...

Next thing you know the EU registries start showing up as 348 patients. Where did that come from? Then in Aug, months later, we finally get the PR, but the sample increase is mentioned along with analysis for cd4 counts, confusing the true cause. Very like NWBO management to do that. They were afraid of the market reaction to increasing n based on blind sample size re estimation procedure, so "hid" that fact in the Aug PR. In fact it happened months prior.

Balance is tough to achieve. One way is to seek to argue both sides, and then choose which one is stronger. At least where investing is concerned. Because there is no gray. You are either long, short, or out.

GLucky


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