NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

https://www.law.cornell.edu/cfr/text/42/11.48

Under § 11.44 d.3 the following is determined
“(3) For each submission of partial results information for a clinical trial, as specified in paragraph (d)(1) of this section: (i) If any amendments were made to the protocol and/or statistical analysis plan as described in § 11.48(a)(5) since the previous submission of partial results information, the responsible party must submit a copy of the revised protocol and/or statistical analysis plan”

So in case anyone was wondering why NWBO has not updated the clinicaltrials.gov with the new SAP, which we know exists from the EMA website. The reason for that is they are required to do so when submitting the trial results and legally not before that date.