NorthWest Biotherapeutics Inc (NWBO)

[Evaluate]

Interesting.
From the 10-K:

In the U.S. alone, on an annual basis, there are some 40,000 new cases of primary brain cancer, and 160,000 new cases of metastatic brain cancer.

and

Further, after seeking regulatory approval for DCVax for the GBM subset of primary brain cancers, in the future we plan to conduct clinical trials and seek approval for other (lower grade) primary brain cancers and for metastatic brain cancers.

From http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM311928.pdf

An orphan drug is defined in the 1984 amendments of the U.S. Orphan Drug Act (ODA) as a drug intended to treat a condition affecting fewer than 200,000 persons in the United States, or which will not be profitable within 7 years following approval by the FDA.

It appears therefor, that DCVax-L would not be eligible for Orphan Drug designation for future clinical trials for other primary brain cancers and for metastatic brain cancers, since that would apparently exceed the 200,000 person limitation (unless it would drop below this number by excluding the GBM patient subset).