Replies to post #114069 on NorthWest Biotherapeutics Inc (NWBO)

[monentum2play]

Funny I had said that months ago that the hold was manufacturing problem. Every company that had a manufacturing live cells had problem getting licensing. It takes around a year. Then you have to do a batch test of DCVAX and that has to be approved .

[marzan]

TC, very interesting for highlighting those bold lettered sentences in the 10k. must be something brewing at the regulatory levels both here and in Europe. Otherwise why putting Cognate personnel there and produce DC Vax L?

[flipper44]

Thanks TC. Here is another section from the 10K that might be of some interest, and in case anybody was wondering, this was in this year's 10K for 2016 -- but not in 2015. In fact, Israel was not mentioned in the 10K for 2015.

Pursuant to an institutional financing of Cognate in October 2016, Cognate’s operations outside the US were separated from its operations in the US. The operations outside the US include Cognate BioServices GmbH in Germany, Cognate BioServices Ltd. In the UK, and Cognate Israel in Israel. Both Cognate BioServices, Inc. in the US and the Cognate affiliates outside the US are owned by Toucan Fund III. The Cognate affiliate in Germany works with the Fraunhofer Institute to produce DCVax-L products there, and Cognate affiliates in the UK and Israel are preparing for production of DCVax-L products in those locations. Approximately $4.3 million of the total research and development cost were related to Cognate entities outside the US are included in the overall amounts reported with respect to Cognate.

[Know-Fear]

Protein based CI's are the smart initial play for BP's. CI's are not individualized (autologous) so are easier to manufacture (batch). As I've posted before one of my holdings BMY (BMS) is spending nearly $2bil to establish their biologic production on two continents. An autologous therapy will need to be proven before BP will jump onboard.

[chinatown1980]

The regulatory requirements relating to manufacturing and cellular products are especially challenging and are one of the most frequent reasons for the development of a company’s cellular products to be put on clinical hold (i.e., stopped by regulatory authorities).

What are your thoughts on this? Do you feel differently? about it now versus when the company said it a year ago in the 2015 10K?