Biotech Values

[DewDiligence]

Thanks, Idit, for the correction re BID vs qD dosing of Lovenox in the comparator arm of the ADVANCE-1 study. Here’s the main point: the FDA seems to be disallowing the ADVANCE-2/3 studies because they used a dose that differs from the dose in the FDA label—even though the Lovenox dose used in ADVANCE-2/3 (30mg BID) is widely used off-label and is the standard of care in these indications in most of the world.

Moreover, 30mg BID is the Lovenox dose in the FDA label for other non-knee/non-hip post-surgical uses of Lovenox for VTE prevention.

All told, I think the FDA is being unreasonable in disallowing ADVANCE-2/3 due to the Lovenox dose, if this is in fact what is happening. Regards, Dew