"This Phase II trial will be a randomized, double-blinded study comparing docetaxel plus bavituximab versus docetaxel plus a placebo. This is a very rigorous study designed with many features typically reserved for Phase III trials and results will be reported when the data are unblinded at the end of the study."
I like that. I've been burned on a Phase 3 that apparently wasn't blinded for the administering doctors. They saw that the patients in the best-of-care arm weren't doing well and then broke the regimen to continue treating them with additional chemo doses, so that the drug being investigated was no longer being compared to a known regimen. The investigatory drug did not do significantly better than the new regimen, and it and the company crashed and burned.
So it's critical to have a trial that is designed properly, and I'll trust that Dr. Garnick knows what he's doing.
But . . . do we really trust the Indian data? Are we sure they didn't just make up some numbers to make us happy? I think that the overseas trials, the small sizes of the trials, the fact that so many early trials lead to later large-scale trials that fail, are all part of the reason that we don't have institutional interest (in addition to the aforementioned "going concern" warning).
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