NorthWest Biotherapeutics Inc (NWBO)

[MI Dendream]

Not to rehash, but the tot bag appeared after a full page advertisement.

I am not backing away from the idea that they were given the Green Light to premarket promote within the acceptable guidance, just that 6 months may be a bit of a moving target due to COVID. I am sticking with UK & US approval is coming soon. Just maybe a few more weeks than the three that remain on the clock.

Let me ask this, when you see structural or culture change there is a precipitating event. What was the precipiating event that finally pushed FDA to change their stance on external controls?

My answer is DCVax SAP submission followed by BLA completion. The rGBM Hybrid ECA designs were already approved despite the guidance be draft, and not the kind of draft that is immediately implemented as they are also known to do. Approving a drug based on this DRAFT is another story.

Parallel paths, both NWBO and FDA are able to focus on more than one thing at a time, and even coordinate those things.