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Friday, August 07, 2015 6:07:35 PM
I see that they don't include rapid data in their safety.
How can you say that? You don't "see" that.
The German Label accounts for 35 patients currently in the information arm - and that is the rapid progressor group which has been presented to us over this past year. 35 was the number enrolled in that group as of August 15, 2012. And yes, some of that group came from 2008.
Here is the quote from the German Label listed later in the file that SUPPORTS that:
The study 020221 is an ongoing Phase III trial. At the time August 15, 2012 increased 41 hospitals in the United States participated in the study and 84 GBM patients were included. Of these 84 patients 49 were included in the primary study cohort randomized (2: 1, active drug versus placebo), and 35 patients were enrolled in an open-label arm of the study, which is designed specifically for patients with rapid tumor progression.
I see that they don't include rapid data in their safety.
Just because you don't "see that" - meaning you think they didn't include the rapid patients from the information arm in the safety data - doesn't make it so. Those rapid progressor patients in the information arm described right above were most definitively counted in the safety data... they were receiving the vaccine! All patients whom had received the vaccine by that time were indicated. Why on earth would you think they wouldn't count the rapid progressors in the safety data... as they represented the largest group at the time actually receiving the vaccine?
In order to determine the safety of the vaccine, the Germans would have been supplied with the safety data on all those patients receiving the vaccine... including those in the rapid progressor information arm, which numbered 35 at the time. The next largest number came from those patients enrolled in the main arm of the trial - those in the treatment arm. Take 49 patients (also mentioned), randomize them, and you come up with an additional 33.
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