Replies to post #817784 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

The company has already run a P1 for Direct. Why on earth would they have to run another one?

A new IND, new API, new manufacturing and possibly a new adjuvant. That is a new drug, just because they still call it by the same name does not make it so.

I expect the trial, if ever launched, would be a P1/P2.

[antihama]

The new improved preparation of Direct will have a new IND but I would think by showing the similarities to the old Direct I'm guessing they can start w a P2 to get to accelerated approval, IMO.

EDIT: Just Ex's post, we're somewhat in the same ballbark.