In the phase-3 trial in question, Andexanet alfa hit all endpoints in reversing the anticoagulant effect of Eliquis. PTLA hopes to convince the FDA that demonstrating an actual clinical benefit for FXa reversal can be done in a post-marketing study, but I’m not sure the FDA will concur. Moreover, I’m not sure the commercial market for an FXa antidote is as large as PTLA claims (#msg-104066689).
I also have questions about PTLA’s clinical program for its own FXa inhibitor, Betrixaban, as noted in #msg-105048954.
-- *The financing announced today specifies $160M in gross proceeds for an unspecified number of shares. If there’s a typical underwriter’s option that is exercised, the amount raised will be $184M.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”