PTLA—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…
I think you’re overanalyzing the situation. The FDA label for Lovenox used as an inpatient treatment for primary VTE prevention in immobilized patents specifies a duration of 14 days (not 10 days ±4 days as PTLA says) because that’s the approximate length of a typical hospital stay for this patient pool. The 14-day duration is not derived from a tradeoff of thrombosis prevention vs bleeding risk, as you posited.
When patients leave the hospital, they are often transitioned from Lovenox to an oral anticoagulant.
All told, I think PTLA’s Betrixaban program is pretty close to being a scam. This opinion is based on:
• The phase-3 trial design (as discussed in prior posts in this thread);
• The spurious contention that Betrixaban is well-differentiated from Eliquis and Xarelto in the indication PTLA is pursing based on its PK profile; and
• Inflated numbers furnished by management about the size of the indication.
If not for the PRT-4445 antidote, I would consider PTLA a promising candidate for shorting.