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Re: p3analyze post# 87432

Monday, 12/14/2009 9:25:34 AM

Monday, December 14, 2009 9:25:34 AM

Post# of 257262
imgn -

It appears that Roche is not in a hurry to file for 3rd line.


Why do you say that? Assuming you are referring to them speaking to the FDA first, what did you expect them to say when there is no SPA?

ONce T-DM1 is approved, those patients randomized to control arm would be clamoring for it upon disease progression.



Thats an interesting point. However as far as the 2nd line trial goes, it should be done by early '11 and tdm1 if submitted won't be approved till late 2010 which wouldn't leave enough time for a significant number of patients to skew the data against tdm1 for 2nd line.

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