NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Thanks. Many longs will cheer his because they fail to read more than the title.

A few choice notes:

15. A RWD ECA comprises patient level data collected outside of a clinical study which will be used as a control or part of a control arm to estimate the comparative efficacy and safety of an intervention being studied in a clinical trial.

26. It is important that the protocol is finalised before enrolment begins e.g. the design and analysis methods should be sufficiently specified in the protocol and there should be no amendments planned to fill in important missing details. Ideally the protocol should encompass all plans for the trial including the use of a pre-specified RWD ECA

27. Without sufficient pre-specification there could be issues related to multiplicity. For example, if a trial is analysed without an external control, and after the analysis an external control is added, this may inflate type I error if it is not clear which was the primary analysis. Therefore, it must be clear what the pre-specified primary analysis for the trial is.

I guess he MHRA failed to read the JAMA paper.