NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

Company is not unblinded until TLD is completed and delivered.

You mean they are going to PR topline without knowing what's in it?
No, perhaps you mean the Stats are going to deliver topline to the company.

'Topline data' is simply a term for whatever the company or trial sponsor decide to first release into the public domain.
It would normally contain a few key significant outcomes and more often than not a reference to whether a primary endpoint has been met.
And perhaps an indication as to when and where more comprehensive findings will be released, and whether a following regulatory application is intended.
Obviously topline release has to be factually accurate, so as not to mislead, and it can't omit a clear adverse outcome, if one exists.

Whatever the Stat's data analysis finds and is communicated to the company, I wouldn't describe it as 'topline'. The company are going to want to know everything about every endpoint including the pre-defined subgroups. Not some abbreviated 'topline'.

From a data integrity point of view, I can see no real reason why the company has to remain blinded until after the Stats have had it for 'several weeks'. After final hard datalock, the results are immutable; they are what they are, and the final version of the SAP went in before the unblind.
So why a requirement for the company to remain blinded for a further 'several weeks'?
If there is a valid reason, I don't know what it is..

Though they might simply prefer to let the Stats do their stuff, without looking over their shoulder as they do it.