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Monday, March 12, 2012 10:33:23 PM
Excerpt from Joe Shan: "I think it's difficult for us to say without trying to compare it with the prior RECIST versions, but these are relatively small studies - I think that's probably one of the bigger contributing factors. And when you look at these scans, like I mentioned in my remarks, that the independent readers, while they are more unbiased, they only have radiographs, so they can only read what they have, and so sometimes if there's not clear progression or an event, then patients are censored in the actuarial analysis, like Kaplan-Meier [ ”Kaplan-Meier Method” – see http://cancerguide.org/scurve_km.html ]. So I think that certainly can contribute to numbers that are a little bit outside of what you expect.
CD: And with regard to the PFS inconsistency, could you remind us what type of imaging was employed, was it CT or MRI?
Joe Shan: Yes, these are typically spiral CTs. MRIs are supplemented for certain anatomies. ".
Later on in the Q and A, Garnick and King mention each patient represents a couple (3?) percent shift in posted study statistics. So PPHM has a small study group where patients got censored from the control arm, yet stats still didn't show much difference between arms. What can be made of that ? Was this front line study able to deliver on expectations? The sixth questioner seemed to delve right in to clarifying how the pending second line study results due mid-year are structured to avoid this cohort investigator results reading confusion. He went so far as suggesting that this second line study would be the bridge to determining whether analysts following PPHM would get excited.
Best wishes and IMO.
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