Replies to post #292247 on NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

Hankman. Learning from experience, I tend to make what I consider realistic time estimates for myself, not best case estimates.
Having said that, and seeing as you asked, I think best case is 6 months plus 6 months. 6 months to BLA submission and assuming they get priority review, 6 months for the FDA to do their deliberations.
Realistically though, I personally wouldn't expect an approval decision until 18 months after topline.

They will get a waiver on the PDUFA fee though, so they won't have to pay for the FDA appraisal of their application.