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Re: drbio45 post# 86859

Tuesday, 12/01/2009 3:06:42 PM

Tuesday, December 01, 2009 3:06:42 PM

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Please give me an example of a cancer trial where there was an open label study in an indication where there was an approved drug?



Accelerated approvals from single-arm Phase II trials are relatively common, especially in blood cancers. That's technically open-label, though probably not what you are looking for.

The FDA has granted SPAs to open label trials. The two GVAX trials were open label, for example. None come immediately to mind that actually worked.

Unless otherwise indicated, this is the personal viewpoint of David Miller and not necessarily that of Biotech Stock Research, LLC

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