Hunting the Cell Loss Data
The Question
Since the placebo treatment consisted of (1) leukapheresis (2) cell processing (3) removal of 2/3 of the cells for freezing (4) refrigeration of the other 1/3 of cells for 36-44 hours and (5) reinfusion of these cells, the obvious question was to quantify the number of cells under discussion. These data were not presented in any public documents, nor did they become available in the redacted versions of the FDA documents released after approval. This text explains how the numbers were found, and shows the calculations behind the percentage losses quoted
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