Replies to post #25012 on NorthWest Biotherapeutics Inc (NWBO)

[austinmediainc]

I thought for HE and reimbursement in Germany the Frauenhofer Institut is manufacturing. Or I am wrong?

No I think you are right. Frauenhofer was to supply Dcvax L for clinical trials and I would assume that would be for the German HE as well. I would think the manufacturing could be moved once we are approved and manufacturing on a full scale.

BETHESDA, MD, July 25, 2012 — Northwest Biotherapeutics, Inc. (OTC.BB: NWBO) (the “Company” or “Northwest Bio”) announced today that its partner in Germany, Fraunhofer IZI, has received the official approval and certification from the regional and national regulatory agencies in Germany (including the Paul-Ehrlich-Institut, or PEI – the German equivalent of the U.S. FDA) for the manufacture of Northwest Bio’s DCVax®-L immune therapy for human patients with Glioblastoma multiforme brain cancer.
Fraunhofer IZI will be able to manufacture DCVax®-L in Germany and supply the DCVax®-L product for clinical trials both in Germany and throughout the European Union.

http://www.nwbio.com/fraunhofer-izi-receives-official-certification-for-manufacturing-of-northwest-bios-dcvax-l-product/

March 10th, 2014 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.

http://www.nwbio.com/nw-bio-announces-two-german-approvals-hospital-exemption-for-early-access-program-with-dcvax-l-and-eligibility-of-dcvax-l-for-reimbursement/