Replies to post #26967 on NorthWest Biotherapeutics Inc (NWBO)

[austinmediainc]

I am confused regarding what point you are trying to make here.

It appears to concern "commercial manufacturing approval".

USA: the facility in Memphis is a commercial facility manufacturing DCVax.
Kings in the UK: there appears to be a commercial facility here that is manufacturing DCVax.
Fraunhofer in Germany: DCVax is being commercially manufactured here.

Eval, we don't have commercial manufacturing approval yet. Cognate has an FDA approved site in Memphis which currently produces vaccine for our Clinical Trials, and Fran has been given approval to manufacture for the German Trial and HE.

Flipper had used KITE and ARGS recently saying that they were way behind NWBO because they didn't have commercial manufacturing approval and only had the approval to produce through a contracted manufacturer (same as us) for their clinical trials. At this point with the exception of the HE, it doesn't seem we have anything more.

[flipper44]

Back for one post today, then returning to gravitational challenges.

Also,

The Company and its partners have completed a 7-month process of obtaining the necessary regulatory and institutional approvals in both Germany and the U.K. to expand the scope of the manufacturing in Germany of the Company's DCVax-L product for brain cancer. The scope is being expanded in two major ways: in its geographical reach, and in the product categories covered.

Geographically, these approvals for expanded scope of German manufacturing will enable DCVax-L to be produced in Germany and supplied across borders to the U.K. for the clinical trials. Getting this important cross-border arrangement in place is a key step towards building a Europe-wide distribution network for DCVax products. Although Europe has a common market, the manufacturing and supply of medical products (and especially products composed of living cells such as immune cells) across borders must meet detailed regulatory and institutional requirements in all countries involved.

This approval for cross-border supply of DCVax-L is in addition to the manufacturing capacity in the U.K. already developed by the Company with its partner, Kings College London. Such cross-border supply and distribution will provide valuable flexibility to draw upon manufacturing capacity in either the U.K. or Germany as needed. It will also enable economies of scale for serving all of Europe.

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.... 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.

Argos and Kite are way behind.