NorthWest Biotherapeutics Inc (NWBO)

[drcs]

external control groups: its not so simple like some (cheerleaders) people are telling you.

in detail; first see the fda protocol:
https://www.fda.gov/media/164960/download

Page 4, (page 7 in pdf document) there is the important sentence:
"Sponsors should finalize a study protocol before initiating the externally controlled trial, including selection of the external control arm and analytic approach, rather than selecting an external control arm after the completion of a single-arm trial."

-> not done by nwbo.

Also see footnote 18: very clear.

Page 13 „Analysis Considerations“ much clearer:
"Before conducting an externally controlled trial, sponsors should develop a statistical analysis plan that prespecifies analyses of interest, such as analyses of primary and secondary endpoints, calculations of statistical power and sample size, and plans to control the chance of erroneous conclusions (e.g., to control the overall type I error probability). The statistical analysis plan should be submitted along with the protocol to the relevant review division before initiation of enrollment in the clinical trial for the experimental treatment.“

So - we think - NWBO has a max. (!) 50-50 chance to get through the application because of the of the subsequent change of the study protocol and the subsequent change of the control arms.

But its not zero !