NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

thank you for that info

NW Bio also has orphan drug status granted in both the US and Europe for DCVax-L for GBM and other glioma brain cancers. The orphan drug laws grant 7 years of market exclusivity in the US and 10 years of market exclusivity in Europe for products that are the first of their type to reach the market. Such market exclusivity could apply to NW Bio’s DCVax-L. If so, the scope could be broad: for treatment with DCVax-L, there are no limitations based on either tumor characteristics or patient characteristics. Generally, any GBM patient can be treated with DCVax-L if their immune cells are adequate and just 2-3 grams of their tumor tissue (roughly similar in size to one sugar cube) can be obtained, to provide the antigens for the product.

One could wonder why the FDA would grant Orphan Drug Designation to two similar treatments in development. Anyone?
Of course, the orphan drug status that was granted to NWBO is now 11 years ago.