NorthWest Biotherapeutics Inc (NWBO)

[Umibe5690]

Not if the FDA decides, instead of approval or outright rejection, to issue a complete response letter. Hard to argue that the FDA abused its discretion by issuing such a letter if it can raise legitimate questions. And that is not difficult to do. The FDA has wide latitude and even though a CRL will delay things indefinitely, the FDA has a right and even a duty to do so if it has questions/concerns.

NWBO's silent strategy could backfire and embolden the FDA to do so. NWBO is rather unknown and has little leverage. Did Beau Biden, John McCain or Susan Bayh(who was on the NWBO BOD) avail themselves of DC VAX L? IMO, not likely.

Why NWBO cannot even defend itself against a poly-sci major who has done a great job creating FUD and battering the share price. This is not lost on the FDA. Anyway, the FDA is a political animal and has its bread buttered by much more powerful and influential interests than NWBO.

How does NWBO deal with this? Silence is definitely not the answer. Stellar results and/or a partnership/BO. At this point, I think many shareholders would be happy with a buck or two BO and call it a day. Going it alone is a long, uncertain and highly risky road. JMHO.