NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Is anyone thinking FDA will not approve based on using Historical Control Group? Or ask for another phase 3 trial?

I do not even expect NWBO to submit a BLA.

The patients randomized to placebo live longer than those randomized to DCVax-L. There is plenty of reason to assume the results were based on no more than "intent for near total resection" compared to other trials. Not exactly strong grounds.

If NWBO actually submits a BLA, the FDA could go nuclear and disclose LP's dirty underwear.