NorthWest Biotherapeutics Inc (NWBO)

[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.