Biotech Values

[DewDiligence]

Perhaps BMY will try to file based on this trial alone although I think they know the FDA would probably want to wait for data from the ARISTOTLE trial.

I think BMY will wait for the results of the ARISTOTLE trial before submitting an NDA for Apixaban in AF/stroke prevention. The warfarin market is a larger commercial opportunity for Apixaban than the aspirin-only market. Moreover, the ARISTOTLE trial is three times as large as the recently completed AVERROES trial; if successful, ARISTOTLE should provide the assurance that doubters need to overcome Apixaban’s tepid results in venous thrombosis and any lingering skepticism they may have about the ability of oral FXa inhibitors to work on the arterial side.