Replies to post #235111 on NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

What do you conclude from that, Lykiri?

It suggests to me that between June '13 and Aug '14, European manufacturing was only approved in the UK.
And then in Aug '14, the green light was given for German manufacturing for 'German patients'.

I don't have any axe to grind here, but it seems to me that some DCVaxL manufacture for the trial likely did occur in the UK at Kings, between 2013 and 2015.

Then something happened. Everything went quiet on the £2m extended contract with Kings.
It's why I still hold possible (small possibility) something happening at Kings being linked to the hold.
UK manufacturing switched to CCGTT, and a year or so later, the UK arm of Cognate became Advent.
Whether any trial dosing manufacture actually happened at CCGTT, I don't know.

But we do know that Advent is now based at CCGTT, and believed to be the sole operational manufacturing site for DCVaxL in Europe.

The move to Sawston has been put back a few times now.

[Hugie]

NWBO !!!!!!

[flipper44]

Right, but the batches for the Phase III trial were manufactured in Germany.

Besides monitoring quality standards at the clinics, manufacturing company Cognate BioServices Inc. also established the manufacturing process and related analytic methods in 2011/2012 at Fraunhofer IZI. Following successful validation, manufacturing authorization was granted specifically for DCVax®-L by the Landesdirektion Sachsen (Saxony Land authorities) and the Paul-Ehrlich-Institut (responsible federal pharmaceutical supervisory authority) in accordance with Section 13 AMG.
Furthermore, applications to conduct respective clinical trials were submitted to the responsible authorities in the United Kingdom and Germany and initially authorized in the UK. Consequently, in June 2013, production commenced for the treatment of patients there. Authorization of the trial in Germany the following year then also gave the green light for the production of batches for German patients, which has been ongoing since August 2014.