NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

[]]Nope. It includes “initial assessments,”and guess what, DCVax-l, while not commercially approved yet, is an established medicine for compassionate use.

Initial assessments of established medicines are a generic's first approval..

Saying the Specials program makes it an established medicine is ludicrous. The Specials program is not even designed for drugs going towards an MA. LP found a loophole to allow it. The Specials program is designed to allow MDs to use unapproved agents for specific patients who have Special needs. It says nothing at all about the drug/biologic being used. The restriction on the manufacturer is no advertising and GMP. That is all.

You have read the Specials rules I assume, so you know this.