Exact shares are up 37% this year -- respectable, especially given the long timelines. The pivotal validation study of Cologuard won't be completed until late 2012, with FDA submission to follow quickly thereafter.
@tiltorama tweets, "@adamfeuerstein, Any thoughts on PPHM news this morning?"
On Tuesday, Peregrine Pharmaceuticals (PPHM) released preliminary results from a phase II study of bavituximab ("bavi" for short) in front-line non-small cell lung cancer patients. Eighty-six lung cancer patients treated with bavi plus carboplatin and paclitaxel (chemo) demonstrated an overall response rate of 39% compared to an overall response rate of 26% for patients treated with carboplatin and paclitaxel alone.
Let's dissect:Kudos to Peregrine for running a randomized phase II study. The response rate in the bavi arm is numerically higher than the control arm but obviously not statistically significant. How do I know? Because Peregrine would have been shouting from the rooftop if the result was statistically significant. In the headline of its press release, Peregrine characterizes the difference between the 39% and 26% response rates as a "50% improvement." That's suspect, especially since the result is not statistically significant. The relative difference between the two response rates is irrelevant. The 26% response rate in the control arm -- those patients who received chemo only -- might be unusually high. In its benchmark phase III "E4599" study of Genentech's Avastin in non-small cell lung cancer, researchers reported a 15% response rate in patients treated with carboplatin and paclitaxel.
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