NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

ILT.
You quoted correctly.

Though I seriously question any need or requirement for this to be with the statisticians for 'several weeks'.
They simply need to apply the data to the Statistical Analysis Plan (SAP), which must have been finalised before the unblind.

There is no need, in my mind, for it to be with the statisticians for 'several weeks'

Nor is there any need for the company not to even see the unblinded data for those several weeks.
And if I was the CEO, I wouldn't wait anyway! The more cogitation time the better.

But yes, the Scientific Advisory Board and probably the trial steering committee need time to digest the unblinded data, draw conclusions, and advise the company accordingly, and then there needs to be a collective conflab between the company, their medical advisors, and the stat guys, before any topline data and topline interpretations are publically released.

Statisticians understand data and stat significance (hopefully), but they don't understand how some data may have more medical significance than other data. And on the other side, the SAB (though some members have experience of regulatory submission and data interpretation) don't possess the pure statistical skills.

So the process shouldn't just be a longitudinal process (first them, then us, then them). It must involve collective thinking, where all disciplines put their heads together.

And needless to say, I trust that this will indeed happen!



JMO underlined!