But that’s not what PTLA is doing in the phase-3 trial!! Instead, PTLA is testing 35 days of Betrixaban against 6-14 days of Lovenox followed by 21-29 days of placebo.
Good catch! I missed that implicit in dual dosing (for the first 14 days the patient is getting both a placebo **and** an active drug) they cannot have "physicians choice" SOC after the end of the Lovenox treatment - because then the patient might be getting both the SOC Oral Anti-coag **and** the PTLA-drug.
So the PTLA drug primary endpoint (35 day VTEs) will produce an uncomparable endpoint (unless they just forgot to list the pre-specified post-Lovenox oral drug in the ClinicalTrials writeup.)
And the PTLA drug is likely to show more bleeds than the "SOC" arm.
Likely to be an interesting AdCom. And note that it won't even be possible to create comparable endpoints after the fact because the Lovenox dosing is +/- days, not to a defined endpoint (like physician's decision).
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