2 fer 1 on EXEL
On the flare issue, the flare question was asked and the docs are not seeing it. They couldn't say for sure whether it happens between scans or doesn't happen at all, but they are not seeing it. Remember also reported data are best response, which is the only way they can report these data since some of these patients were randomized to placebo in the RDT since bone scan improvements don't count as responses under RECIST.
Sanofi argued hard for pain to go on the Tax label and the FDA didn't give it to them. As you know from reading our work I ahve always thought there was something fishy about the TAX-327 data. One of these days when I have a week to burn I might go through the FDA docs and see why the FDA rejected it.
The standard is 2-points on the scale, not 1 point. Satraplatin tried to use 1 point as part of their non-SPA composite endpoint. That was one of the things that got them into trouble.
As to rigorous measurement of the XL184 pain data, I would answer it was not. Not all patients had pain assessments. It happened at some centers but not all. BMY was sloppy in the setup of this trial, sloppy in the running of it. About the only thing that isn't sloppy are the bone scans since these are so run-of-the-mill for uro oncs to run.
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