[chrisy]

Phil,
Maybe this is just my paranoia talking, but thought you might find this "draft guidance" re clinical trials interesting.

[URL="http://www.medpagetoday.com/Washington-Watch/FDAGeneral/36607"]

I may have messed up the link but you should be able to find it.

My evil reading of this: in order to speed up the approval process, the guidance is to " enrich" study populations to exclude those less likely to benefit. While this makes sense on the surface (include only her2+++ in trials of her2 directed therapy) and that example appears to be the intent, by extension this could mean excluding heavily pretreated or even ALL stage IV as they are clinically less likely to benefit than more "naive" patients.

Further, the mention that these "enriched" data be noted in the labeling. This is there potential for even more of the restrictive approvals such as with Perjeta?

Like I said, maybe it's just my paranoia talking, I guess any guidance and clarity
the FDA can give developers can help avoid some of the bad calls on TDM1. But this FDA is making it extraordinarily difficulty to conduct trials for Stage IV patients thus throwing out the very babies that need effective treatments the most with the bath water.