NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

"major protocol changes are not credible if knowledge of interim outcome data is available to any individual who is involved with those planning the change. If there is any potential for such changes, sponsors should be encouraged to describe fully who has had access to data and how the firewalls were maintained, among other information. "

www.fda.gov/media/87621/download