Replies to post #392607 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

I discussed my view of the most recent clarification and pointed the language out to others who had missed it. I think it is an approach of least resistance, and a starting negotiation point, first with regulators, then also with third-parties if they get it approved. They can play a bit harder to get if they don’t absolutely need local manufacturing.

[ATLnsider]

hyperopia, I believe the simple explanation for the change in language is due to Brexit. Up until 12/31/2020, the UK was part of the EU (European Union). So, NWBio could refer to all the EU, including the UK, collectively as the “European region”.

However, once the UK separated from the EU due to Brexit, effective 1/1/2021, the UK was no longer part of the EU. As a result, NWBio had to refer to the UK by itself, separately from the European region.

Also, other countries outside of the EU, but are in the area, like Switzerland, can be referred to as in “other regions. So, although Switzerland is in Europe, they are not in the EU. But, because Switzerland is 1 of the 6 participating Project Orbis countries, SwissMedic can still approve DCVax-L through the Project Orbis program. And, the Switzerland market can be serviced through Sawston, unless SwissMedic gives NWBio different requirements.

[flipper44]

CRL’s international reach, imo, means the UK (Sawston) won’t have to supply everyone outside the Americas. This is a fluid expansion, with consolidations and acquisitions mixed in. Imho.

Fun fact. Orbis and CRL are essentially active in the same countries.

[exwannabe]

BTW - Do you (or anyone else) have an explanation for the language change from this:

Fairly clear what it says. They no longer have plans for using Cognate.

The section of the 10-K used to say the rely on Cognate in the US/Canada and intend to use Advent for Europe. It now says they have used Cognate in the past and intend to use Advent for UK and other regions.

That is just one clear statement in the 10K on the subject. Many others show the same. For example, the shutdown liability:


2019 page 27:

(6) We have possible contingent obligations to pay certain fees to manufacturers if we shut down or suspend programs.

For Cognate BioServices (in addition to any other remedies) if we shut down or suspend its DCVax-L program or DCVax-Direct program, the following obligations exist are not reflected in the accompanying balance sheets. See Note 12, Variable Interest Entities, for further details.
...
While our DCVax programs are ongoing, under our agreements with Cognate we are required to pay certain fees for dedicated production suites or capacity reserved exclusively for DCVax production, and pay for a certain minimum number of patients, whether or not we fully utilize the dedicated capacity and number of patients. The same is the case under our agreement with Advent.

2020 page 28:

(5) We have possible contingent obligations to pay certain fees to contract manufacturers if we shut down or suspend programs.

For a shut down or suspension of the DCVax-L program at Advent, the Company must give 12 months’ advance notice. During the notice period services would still be provided. Minimum required payments for this notice period total approximately £3.8 million ($5 million).

And under manufacturing service agreements:

2019 page F-27:

Manufacturing Services Agreements

The Company has manufacturing services agreements with Cognate BioServices in the US, and with Advent BioServices in the U.K.

2020 page F-35:

Manufacturing Services Agreements

The Company has a manufacturing services agreement with Advent BioServices in the U.K.

Reason is obvious.