Thursday, January 10, 2013 5:55:50 AM
If I remember well there was only one historical control arm MOS that was below ours, all the others where more direction 7 Months.
Going even lower then 5.6 months could raise questions, unless the patients in the historical SOC+placebo arms where in better condition then the L3/L4 enrolled ones in our CT.
If I would be the FDA I would in all cases, ones historical comparison data is available as is the case here, investigate results that are not in range of historical statistics.
Peregrine Pharmaceuticals to become the Microsoft of Biotechnology! All In My Opinion. I am not advising anything, nor accusing anyone.
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