NorthWest Biotherapeutics Inc (NWBO)

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Hard to believe there is still negative commentary about the partial clinical hold that subsequently was lifted after allowing active treatment to continue to full enrollment while restricting new placebo patients to enter the trial, quite illogical if there were any active treatment doubts.

There was no failed IA in 2015 for multiple reasons starting with the company statements and the subsequent 6 years of trial continuation and product use continuation by top medical community practitioners.

All my opinion of course.

Multiple people have addressed this and I apologize if this is redundant but the way the SAP document works today is:

- a draft SAP is typically done at time of protocol or shortly after, complementing the stat plan in the protocol (the stats and trials became more complex and needed another document which allows more flexibility for possible stat mods prior to unblinding)
- the SAP must be finalized (as has been stated stated on this MB multiple times) prior to unblinding of the data/results and sent to FDA for commentary, particularly if there are significant changes
- sending to FDA also confirms finalization timing, though with
today's validated electronic document systems it is quite
difficult to falsely date a document
- the SAP is not required to be drafted early but it is recommended
and in most cases today it is of significant benefit due to the
complexities of and attachment of the stats to the data
collection

The regulatory guidance and in-practice usage of the SAP document is still evolving and has been evolving through guidance such as ICH E3&9. Since NWBO began this trial over 10 years ago, when they first drafted their SAP is unknown to me, it could have been close to data lock-unblinding or it could have been earlier and then modified close to data lock-unblinding, it is inconsequential from a compliance perspective. Senti seems sure there was no SAP until closer to datalock-unblinding. What matters most is that they modified and finalized prior to unblinding, which they apparently did. It is illogical to do an IA without an SAP to specify and control all the activity and possibilities that could arise. In addition they informed shareholders they would not unblind until they received feedback from the 4 RA's they worked with in the trial on the modified SAP.

All good here, my opinion of course.

GLTA