Biotech Values

[DewDiligence]

It's worth repeating again that Pazdur has no statutory authority in this area. Legislative intent, in fact, argues directly against this desire. But people have learned not to cross him or he'll tie up your drug in limbo until he gets what he wants anyway.

Pazdur presumably thinks he’s closing a hole that Congress left open inadvertently, which has allowed some companies to delay confirmatory trials indefinitely. It’s indisputable that Congress doesn’t always say what it intended to say, e.g. in allowing multiple 30-month stays for Orange Book patents in the original Hatch-Waxman act.