NorthWest Biotherapeutics Inc (NWBO)

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George Bailey said:

”The definition of established medicine includes medicine in use for 10 years with safety and efficacy making it established. I conclude since DCVax was not previously approved then the National established medicines rules regime do not apply.” — GeorgeBaily

However, over a decade ago, NWBO had already provided many months of data to achieve this.

BETHESDA, MD, September 16, 2014 – Northwest Biotherapeutics (NASDAQ: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that its DCVax-L is the first product to receive formal designation as a “Promising Innovative Medicine” (PIM) under the new “Early Access to Medicines Scheme” (EAMS) launched in the UK in April 2014. A PIM is the first step in a 2-step process for early access approval under the EAMS.

The PIM designation for DCVax-L covers all malignant gliomas, which would include both Glioblastoma multiforme (the most severe grade) as well as less malignant grades, and would include both newly diagnosed and recurrent gliomas.

The EAMS is an important new initiative in the UK, launched by the Medicines and Healthcare Products Regulatory Agency (MHRA, the FDA of the UK), to lead the way in accelerating patients’ access to innovative new medicines for serious diseases. Information about the EAMS program can be found on the MHRA website at: http://www.mhra.gov.uk/Howweregulate/Innovation/EarlyaccesstomedicinesschemeEAMS/index.htm

The first step under the EAMS is MHRA’s scientific evaluation of whether a product candidate meets three criteria for a PIM designation: (i) the product is for a serious disease or condition with high unmet medical need; (ii) the product is likely to offer a major advantage over treatments available today; and (iii) the potential adverse effects of the product are outweighed by the potential benefits.