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Is the FDA under new Commissioner Scott Gottlieb willing to be flexible with the rules, and maybe even lower regulatory standards a wee bit, to approve new drugs? It’s a question that will be partially answered in the coming days when the FDA hands down a decision on betrixaban, a new anticoagulant developed by Portola Pharmaceuticals.

Portola is asking the FDA to approve betrixaban to reduce the risk of dangerous blood clots in patients who are leaving the hospital after treatment for a medical (as opposed to a surgical) illness. The betrixaban clinical data, however, are messy. The drug failed to significantly reduce blood clots, when compared with placebo, in its sole phase 3 clinical trial. Normally, a negative study would stall an FDA submission, but Portola pushed ahead anyway, offering an alternative interpretation of the data.

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  • Bullshit. The drug did not fail to significantly reduce blood clots. It actually did significantly reduce the thrombosis across the the entire population. Just FYI: there is no “p=0.05” rule in FDA.

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