Northwest Biotherapeutics ( NWBO) takes umbrage at anyone who describes the German Hospital Exemption decision for its brain cancer vaccine DCVax as "compassionate use."
"There are some commentators who have either misunderstood or mis-represented what we achieved and what I just described to you," said Northwest Bio CEO Linda Powers, speaking at a conference Wednesday. "Some commentators have said this [German Hospital Exemption] is just the same as compassionate use. That just reflects a complete lack of knowledge of the European system."
May 18, 2011
Northwest Biotherapeutics announced today that it is partnering with Fraunhofer for production of DCVax-L for brain cancer, for clinical trials and compassionate use cases in Europe...
The Fraunhofer Institute for Cell Therapy and Immunology IZI, based in Leipzig, Germany, has dedicated a substantial portion of its state of the art manufacturing facilities to the production of DCVax®, and is assisting NWBT with the applicable regulatory requirements for both clinical trials and compassionate use cases. The Fraunhofer IZI is also selecting and initiating connections with leading clinical centers on behalf of NWBT and its DCVax products.
May 1, 2012
Northwest Biotherapeutics, Inc. today announced that, working together with the Fraunhofer Institute (IZI), it has received approval of a major grant from the Sachsische Aufbau Bank (SAB or Saxony Development Bank) in Germany. The grant will reimburse fifty percent (50%) of the costs for manufacturing in Germany and for NW Bio's clinical trial with DCVax-L for brain cancer at up to 30 clinical sites in Germany...