Please describe your background with Factor Xa treatments and your clinical practice. What are your current prescribing preferences for Anticoagulants?

Now that Betrixaban is approved, what are your thoughts on the label and data that supported it?

How do you see the approval of Betrixaban? Is it recommending a paradigm shift in how the labeled patients are cared for or just an incremental option in how these patients are to be cared for? 

If it is a paradigm change, do you think there is enough information / understanding of the drug for that shift to occur?

How important is the approval of Betrixaban? Will you prescribe it? How widely?  Do you anticipate any hurdles to adoption as the approval of betrixaban for this indication would change current medical practice?

• Specifically comment on the use of anticoagulation for the post-hospitalization period rather than just during hospitalization
• Do you anticipate any monitoring concerns on giving patients a short term anticoagulant following a hospitalization for acute medical illness?

Please comment on the Phase 3 APEX trial of Betrixaban for the treatment of acute medically ill patients:

• Overall robustness and clinical relevance of the data
• Importance of the statistical miss on the primary endpoint in the positive D-dimer population (cohort 1)
• Local vs. central D-dimer testing
• The statistical meaning of missing the primary endpoint by 1-2 patients on the implication for regulatory approval

How important are the advantages of Betrixaban marketed by Portola, namely:

• Longer half life: 19-25 hours for half that for competition
  
• Renal excretion: 5-7% versus 4 to 10 x that for competition
  
• CYP3A4 Interactions: None versus Yes for Xarelto and Eliquis
  

Please comment on the Phase 3 APEX trial of Betrixaban for the treatment of acute medically ill patients:

• Side effect profile

1. Major bleeding risk
2. Clinically relevant non-major bleeding imbalance

Please comment on the Phase 3 APEX trial of Betrixaban for the treatment of acute medically ill patients:

• Side effect profile

1. Major bleeding risk
2. Clinically relevant non-major bleeding imbalance

Andexanet alfa, a potential universal antidote for Factor Xa inhibitors, is being developed for the treatment of serious uncontrolled bleeding or for patients who require urgent/emergent surgery. Please provide your opinion on this clinical candidate:

• Do you believe a sufficient amount of clinical evidence on efficacy has been generated to date?
• Does the short term efficacy, potentially requiring a continuous infusion, impact it’s probably usage?
• How does the half-life of the underlying Factor Xa inhibitor impact its usage?