Replies to post #608247 on NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

Yep it can be decades

[exwannabe]

There's no universally accepted baseline of time for preparing a biologic licensing application.

There certainly are plenty of examples though, virtually every approved drug.

I have never seen it taking longer than about a year from data cutoff. I imagine somebody might find an odd example otherwise, but even if so that is the exception, not the norm.

NWBO is over 3 years now (data cutoff would be prior to locking of the clinical site databases that was announced in June 2020).

Well, CVM is in the running for the same timeline. Maybe it is just a lot harder to submit based on a trial that the FDA put on hold due to futility,