NorthWest Biotherapeutics Inc (NWBO)

[Poor Man -]

Interesting, their lawyers' are attempting to challenge FDA's delegated authority as unconstitutional by referring to their decision for the hold as extra-statutory. Although I don't know how they necessarily equate "such other" with "extra-statutory" when it comes to the regs, especially since "such other" specifically refers to reasons established within the regs itself.

Fifth Amendment’s Due Process Clause by depriving REGENXBIO of a protected interest without even the most basic procedural protections. In addition, Section 505(i)(3)(B)(ii) of the of the Federal Food, Drug, and Cosmetic Act (“FDCA”)—which authorizes FDA to issue clinical hold orders—is unconstitutional because it delegates unfettered discretion to FDA to issue a clinical hold order for “such other” extra-statutory “[color=red]reasons as [FDA] may by regulation establish.[/color]” 21 U.S.C. § 355(i)(3)(B)(ii).