NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

There is a reason why RA demand patient level data for the primary approval decision. It is not unexpected the MHRA guidance followed suit.

The JAMA paper notes the lack pf patient level data as a limitation. So basically the authors or saying this trial is not suitable as the primary decision for efficacy.

LL was asked about that in an interview. She did not try to deny it was an issue for approval, When asked if there would be a well designed trial to establish efficacy simply said that it would be up to NWBO. And she hoped there would be some way for patients to get -L in the meantime.