NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Maybe you should look up that other dendritic vaccine while you’re at it and tell me how long Provenge took to get approved?

DNDN tried in 2006/7 to gain an approval based on 2 P2 trials that failed the primary PFS endpoint by noting in a post hoc analysis they showed an OS benefit. The FDA denied them on that, So they completed the ongoing P3.

DNDN completed the IMPACT P3 trial in April 2009.
DNDN submitted the BLA based on the P3 Nov 2009.
FDA approved in April 2010.