Biotech Values

[DewDiligence]

PTLA—Please expand on why and how you think that the phase-3 trial for VTE prevention in hospitalized patients is rigged?

The Betrixaban trial arm treats patients for 35 days, while the Lovenox comparator arm treats patients for 6-14 days!

PTLA is hiding behind the purported requirement to dose Lovenox in precise accordance with the FDA label for this indication, but this causes the comparator arm for about 70% of the trial’s duration to be a placebo rather than an active agent.

Thus, I find the trial design rigged and the logic disingenuous. It’s not far-fetched to think that this phase-3 trial will hit its primary endpoint and yet be massacred by an advisory panel and rejected by the FDA.