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DonShimoda

10/28/10 12:45 PM

#2992 RE: BTH #2990

Despite your continued insistence that it's a 50/50 gamble, I hardly think MRK and ARIA invested hundreds of millions of dollars, and Berger $3 million personally, on a complete "gamble". Not hardly. While the placebo group is most certainly progressing more slowly than the historical P2 data would suggest (which is not surprising given that the P3 pts were disease stable at the time of enrollment), that doesn't mean that the trial is any less likely meet its endpoint only that the trial is likely to take longer meet its endpoint, which it apparently is. You make it sound as if it's an either or situation when it's much more likely a combination of the two - the placebo arm is progressing more slowly AND the rida arm is working as designed:

"The data from the overall survival analysis of the Phase 2 trial further support our Phase 3 trial design and strategy, which focuses on metastatic sarcoma patients . We believe this well-defined patient population has the greatest likelihood of achieving sustained clinical benefit from treatment with a new molecularly targeted agent such as AP23573."

btw, what GNVC and NVLT did or didn't do has no bearing what so ever.