Replies to post #17520 on NorthWest Biotherapeutics Inc (NWBO)

[longusa]

gnawkz, NW already has PEI-approved manufacturing in Germany; Fraunhofer was set up as manufacturer via installing Cognate's process over a several year process. This item in the 10Q must then refer to the need for expansion beyond what Fraunhofer can do, so I take it as indication that NW expects significant HE demand in Germany, and as well is setting up manufacturing for all of EU, like Cognate in Tenn is for all of US.

See this from the March 12, 2013 PR

NW BIO ESTABLISHES CROSS-BORDER MANUFACTURING AND DISTRIBUTION FOR DCVAX® IN EUROPE
Approvals Expanding the Scope of German Manufacturing Are Key Steps

...on pg 2:
In regard to the product categories, these approvals will enable DCVax-L to be produced in Germany not only for the Phase III clinical trial, but also for Hospital Exemption cases under Section 4b of the German Drug law (similar to compassionate use in the U.S.) Separate regulatory applications and authorizations are required, at both the Federal and local levels, for the manufacture of products for Hospital Exemption (Section 4b) versus for clinical trials.

The Company and its partner, Fraunhofer IZI, already received the manufacturing authorization for the Phase III clinical trial last summer, as the culmination of a 1-1/2 year process of technology
transfer, regulatory applications, regulatory review and inspections.

The separate manufacturing authorization for Hospital Exemption cases (Section 4b) has recently been approved as well, by the local regulators and the German Federal regulator (the Paul-Ehrlich-Institut, or PEI – the German equivalent of the U.S. FDA).

The Company is now awaiting a decision from the same German regulator (the PEI) on the Company’s Section 4b application itself (the application for approval to treat Hospital Exemption
cases) – the cases for which the manufacturing authorization has now already been received. The Section 4b application was submitted to the PEI last fall, following a 5-month Scientific Advice process with the PEI.

And we know now that approval to treat was received March 2014.