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06/24/13 6:23 PM

#163007 RE: DewDiligence #163004

PTLA -

Would anyone have gotten the answer?



I did guess that answer - and while I'd agree regarding the stroke event endpoint as a standalone entity, I wouldn't agree overall. And I don't agree because for this type of drug there are two endpoints upon which they are judged even if one is "unofficial". By being on drug longer they are risking more bleeds with every decreasing benefit (presumably the rate of VTE decreases fairly quickly vs time).

Put another way - I presume that the Lovenox label of 10 days is sized to switch off drug when the on-going risk of bleeds starts to outweigh the ever decreasing risk of VTE. Any competitor drug should be judged the same way - so if they think their drug has substantially lower risk of bleeding then they should continue longer. In fact an argument could be made that they should run a little longer in order to decide where that crossover of VTE benefit vs bleeding risk occurs.

The only thing I find disingenuous about the Clinical Trials writeup is their not listing the safety endpoint of bleeding.