How could it possibly be double-blind? That would mean they would need to inject a placebo using a fairly invasive procedure. I'm sure the ethics committee would have some difficulties with that. Sirflox was open label and probably a good guide to what FDA would expect.
More likely is Oncosil+gemcitabine vs gemcitabine alone as control. I don't think FDA like historical controls unless absolutely necessary......[which I now see is exactly what rg said!]
How could it possibly be double-blind? That would mean they...
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