Northwest Biotherapeutics announces two German approvals Northwest Biotherapeutics announced that it has received approval from the Paul Ehrlich Institute of a "Hospital Exemption" early access program under Section 4b of the German Drug Law. Under this Hospital Exemption, NW Bio may provide DCVax-L to patients for the treatment of any glioma brain cancers, both newly diagnosed and recurrent, outside of the company's clinical trial and charge full price. The patients may be from Germany or elsewhere. This approval has a term of five years, and can be re-applied for and re-issued at the end of that period. DCVax-L products that are to be covered by the Hospital Exemption in Germany must be manufactured in Germany, but can be administered to patients from anywhere. As in the company's clinical trial, DCVax-L will be administered under the Hospital Exemption as an adjuvant treatment after surgical removal of the tumor and radiation/chemotherapy where applicable. The company will provide annual data reports to the German regulatory authority during the five-year term of the Hospital Exemption. The company expects to activate this program over the coming months.
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