Replies to post #69685 on NorthWest Biotherapeutics Inc (NWBO)

[HappyLibrarian]

FDA takes forever on even idiot-proof things (see our screening halt) so we might be waiting a long time even if you're right. That said I sure hope you are, because I'll money in that case!

[AVII77]

The done deal is pending on the FDA green light to begin dosing patients with combo PD-L1/DCVax direct and PD-1/DCVax direct.

IND's would be required for both of these trials.

Has it been 30 days?

Maybe the the FDA imposed a Clinical Hold on these INDs also.

Nah, that couldn't be possible, NWBO always clearly discloses .... wait a minute, wat?

Notwithstanding doc logic's suggestion that there might be sufficient experience in the clinic evaluating the combinations, I think the FDA will likely require a Phase 1. Or, at least, a dose escalation component built into a Ph 2 with a restricted early enrollment rate.