Replies to post #560069 on NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

Please reread the documents. I still think you are mixing up the trial number as a date.

have a good one gro.

[CherryTree1]

Not sure this post has to do with this allegation which I was responding to:

the protocol, the endpoints, the comparators and the SAP. All the trial had been complete. It is unheard of

Like I shown you repeatedly in detail it have been standard practice for well over 20 years.
so again
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=170236939
Completely false and the protocol NWBO is following have been standard practice for some time.Here is information from 2010
http://onbiostatistics.blogspot.com/2010/04/when-to-finalize-statistical-analysis.html

When to Finalize the Statistical Analysis Plan (SAP)?
"The statistical analysis plan may be written as a separate document to be completed after finalising the protocol. In this document, a more technical and detailed elaboration of the principal features stated in the protocol may be included. The plan may include detailed procedures for executing the statistical analysis of the primary and secondary variables and other data. The plan should be reviewed and possibly updated as a result of the blind review of the data (see 7.1 for definition) and should be finalised before breaking the blind. Formal records should be kept of when the statistical analysis plan was finalised as well as when the blind was subsequently broken.
If the blind review suggests changes to the principal features stated in the protocol, these should be documented in a protocol amendment. Otherwise, it will suffice to update the statistical analysis plan with the considerations suggested from the blind review. Only results from analyses envisaged in the protocol (including amendments) can be regarded as confirmatory."

This indicated that the ICH principal is followed as long as the statistical analysis plan is finalized or signed off prior to the study unblinding (or database lock if it is open label study). I believe this is the common practice in industry.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.