NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

biosectinvestor,

You made a bit of a mental leap in your first conclusion. The reason for a self imposed hold can be varied including the possibility that blinded data points to a strong trend, which if statistically and more specifically confirmed, could lead to an ethical dilemma for a regulator hence a deeper, not necessarily completely unblinded, look by regulators. Look at the time line of the NWBO 2015 Spring Refresh not disclosed until 2017, which was a blinded look followed by the halt after time for conclusions to be drawn. PEI guidance clearly states that a sponsor can self impose a halt voluntarily and, as just described, the reason doesn’t need to be because of seeing unblinded data but potential concerns about ethical treatment or potential safety concerns seem to rise to the top.
Take a look at a recent voluntary halt by Astellas on 09-01-2021 of their x-linked myotubular myopathy gene therapy trial
https://globalgenes.org/2021/09/01/astellas-voluntarily...
Best wishes.