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Thurly

01/10/13 2:26 AM

#107239 RE: freethemice #107217

I'm pretty confident we will move to PIII, at least in the USA.
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Protector

01/10/13 5:55 AM

#107251 RE: freethemice #107217

FTM, doesn't it pose any problems that the control arm goes even lower then 5.6?

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.