NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

Marzan, I do hope your optimism is well -founded!
My own view, as stated previously, is that I doubt that adoption of any new guidelines will make much material difference to NWBO.

The FDA had the flexibility to make exceptional decisions previously, so I don't envisage much change, excepting change that further benefits BP.
After all, wasn't that the point of the exercise? (He says cynically.)

And as a proponent of Evidence-based medicine, I don't support approvals that are based solely on post-hoc or ad hoc subgroups.
But, meth / unmeth was prospectively identified and stratified for, and is universally accepted as the most important prognostic biomarker, so that subgrouping comes with validity.

On historical controls, I would just say that the EF-14 trial Optune trial is a form of historical control, as are Stupp 2005, Brandes and one or two others. The more that our OS data (particularly at OS36 and further) surpasses EF-14, the more difficult it becomes to not approve.

But hey, the US is only one theatre anyway!
UK and Europe may be positively different.

JMO.