Re: Analysts are not impressed . They should be
Ernie, I would love your thoughts on why you expect a positive outcome from Andexxa phase 4 study. It will come out in 4 years (estimate study completion date is Nov. 2023)
I think a positive outcome would depend on what is used as "usual care." And if the usual care includes Kcentra, it'll depend on the concentration of FXa inhibitor in the blood at the time of treatment. Kcentra does not work unless the concentration of FXa inhibitor in the blood is low. That's why I wish the inclusion criteria would have tightened up to something like within 10 hours of taking FXa inhibitor rather than 15 hours.
Retrospective analysis of use of Kcentra shows about 69% hemostatic efficacy. I think Andexxa will clock in at 80% or better. For me, it's too close for comfort. I think the outcome will be more certain if the patient is treated closer to taking of Eliquis/Xarelto. Also, I'm not sure how many patients will get Kcentra as part of 'usual care.'
It will take 4 years for us to find out. That's a long time.