Replies to post #251007 on NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

Good someone is going after them .

[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).

[biosectinvestor]

Seems like it could be a basic violation of the administrative procedures act that governs this kind of agency action.

Key language is here “FDA’s final agency action is contrary to law and arbitrary and capricious because it did not follow the statute or its own regulations, nor did FDA offer a reasoned explanation for issuing a clinical hold without advance warning”.

That it qualified that they did not offer a reasoned explanation ... “without advance warning” i am not sure that they owe them advance warning if it was a reasoned decision. But if it was arbitrary and capricious, which it may have been, they could have a good chance at a remedy.

I’d want to know more, but very interesting situation.

[exwannabe]

Should be fun to watch. The FDA will (I think) be able to tell their side of the story which rarely happens in this space.

I am a bit curious what the point of the suit is. There is no way I see a Judge making a summary judgement to lift a hold. I could see the Judge issue an order to force the FDA to state their reasons, but the FDA has already said they would have the formal reply by Nov 15 so I fail to see the point.

The argument that the CFR is an unlawful delegation is worth a laugh. If that was the case, 90% of US Federal law could be tossed.

[TopelRoad]

That is an interesting regulatory strategy (read extremely bad idea).