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Re: sunstar post# 48673

Thursday, 03/18/2010 5:21:59 AM

Thursday, March 18, 2010 5:21:59 AM

Post# of 347009
sunstar,

If the data is good, it looks like the soonest bavi could get approved would be the first half of 2012. On last weeks CC SK said:

The size of the trial for the double-blinded placebo-controlled 2nd-line combination with docetaxel, we’re anticipating a 120-patient clinical trial. We haven't publicly disclosed anything on the front-line study yet – we’re still finalizing the protocol and some of the particulars on that. Our goal is to enroll the study in approximately a year. Obviously, the key for meeting that enrollment criteria is to have an adequate number of sites, so we’ve done some feasibility studies, looked at the average of number of patients they think they can put on per month. And then we’re kind of powering the number of sites to achieve that enrollment goal. So once we get started, we’ll be able to really look at how it’s tracking, determine if we need to add more sites on, but our goal is to get it done within a year, which should put us in a good position for data from the trial in late 2011 or early 2012, but ideally late 2011.

mojo
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