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Replies to #86849 on Biotech Values
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poorgradstudent

12/01/09 1:13 PM

#86851 RE: drbio45 #86849

Didn't the chemgenex trial use a single arm omapro design in imatinib resistant patients even though Sprycel (approved mid '06) and perhaps Tasigna (approved late '07) were both approved and available?
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rkrw

12/01/09 2:28 PM

#86858 RE: drbio45 #86849

No, that's not what i'm saying. I expect an open label study.

I don't think the fda will be curious about Omapro+ariad and I don't think the combo will lead to cures. That's certainly a very speculative trial idea you have and would take many many years to accrue and run.

Like i suggested we can just wait and see what happens with the Omapro nda and the ariad pivotal trial. The trial design should be clarified by the middle of next year.