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biomaven0

05/26/12 1:47 PM

#142711 RE: jq1234 #142710

011 arm: TN but not HG: 1/13 (8%)
IC arm: 0/6



Thanks - I'd forgotten that you had done this analysis. So my point here is that TN is most likely a heterogenous group, and with 13 patients you may only have a couple of patients from each subgroup, or maybe not even that. A 10-15% response rate in this group might be enough for approval, so it makes no sense to abandon it on the basis of this trial.

I think they need a 200 or so patient Phase IIB trial in TN, stratified by HG. If the results are good, that could serve as a pivotal trial.

Peter