NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

The FDA has allowed historical controls in some situations for over 2 decades.

What I have never seen is a company running a randomized trial, and when the comparison between the arms fails tries to get approved based on post hoc endpoints against historical comps.

Have seen other trials where "everybody lived longer", but the arms did not separate. No approval.

I do not expect a BLA to be filed w/o at least the original OS endpoint being a success. Doing so opens a risk that the FDA will accept it for review then call an ODAC to go public. LP may not want that.