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Re: DewDiligence post# 154030

Thursday, 12/13/2012 1:08:31 PM

Thursday, December 13, 2012 1:08:31 PM

Post# of 253375
The ONCY report offers Phase III H&N response results from a metadata snapshot of the metastatic disease group. This double blinded (but fully enrolled) randomized Trial remains blinded. Without singling out the named metastatic group it typically takes 8 weeks to get a meaningful spread in data for these H&N patients (learned from 2 Phase II trials), but I suspect that the this 6 week data (the choice at this point was 6 vs 12 week) was made to minimize a statistical hit, and was done now because a late July PFS snapshot before enrollment had completed suggested that the metastatic results could show an earlier spread.

Today's results might lead to an earlier unblinding than was previously expected.

rjc
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