Replies to post #430460 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

You speculate there is a contract in place between NWBO and Advent ok lets say there is.

Theer are 2 contracts known to be in place.

One is for "Specials". NWBO pays Advent about $5M a year to run that program.

The other is for Sawston buildouts. That is on a piece basis and is 15% + cost with no agreement for further work.

For actual commercial manufacturing, that would be a required disclosure as it would be material contract between related parties. None has been disclosed.

Oh, I am sure LP and LP have a general agreement. Somehow, they cannot agree enough to get it on paper.

[Maverick0408]

We have the same thought process. I don’t care what additional money they (Merck) pay to purchase Advent as long as we (NWBO) get the value our technology deserves. Advent wouldn’t cost them much, probably around $100M or thereabout….when they pay around $20B for NWBO acquisition, another $100M is a drop in the bucket. But this gives them immediate access to trained and experienced personnel that can not only scale the existing facility but also help them to conceptualize, expand, and build out bigger manufacturing operations around the world in a relatively quick fashion rather than starting from ground up. For them, the most important thing is going to be to realize revenue growth as quickly as possible. That’s the best way to justify such an acquisition, otherwise it’s not even going to get approved by their board….forget about analysts and investor community post acquisition….

[Lykiri]

We keep forgetting that the legally independent company Advent is in possession of the granted license to manufacture DCVAX products and NWBO is NOT. If NWBO were to be acquired and Advent will remain independent, then the acquiring party is incredible vulnerable in its quest for production. Any BP now owning NWBO will have then unwanted uncertainty if Advent will be able to keep producing DCVAX in the future for the acquiring party yes or no.

dennisdave,

The facility holds the licence. And the facility is owned (leased) by Northwest Biotherapeutics.
Read the email attached from Richard Parker, Senior GMDP Inspector MHRA, replying to my inquiry.

Nov.1, 2021

Dear XXXXX,

Thank you for your email.

You are correct that a facility manufacturing an ATMP must have a current GMP Certificate to manufacture either an IMP(material for clinical trials) or an MA product.

If the facility is in the UK or EU it must also hold either a Manufacture Import Authorisation MIA or a Manufacture Import Authorisation for Investigational Medicinal Products MIA(IMP) depending on what product is being manufactured. If in the UK the facility/company must apply to the MHRA for an MIA or MIA(IMP) and this process could take 90 days, during which time an inspection will also be carried out at the facility. Depending on the time taken to close out the inspection and issue the GMP certificate/s this may be longer than 90 days especially if there are any issues found at the inspection. This application can be made at the same time as the MA application so long as there is an intention to manufacture product at the manufacturing site. However, it should be noted that the processes are independent of one another and an MIA and or GMP Certificate must be in place for the manufacturing facility before the Marketing Authorisation can be granted.

If the facility performing the manufacture is outside of the UK but in the EU it is a the current time the responsibility of the competent authority in that country to carry out such an inspection and issue the manufacturing authorisations, which are recognised by the UK.

If the site is a third country then MHRA would carry out an inspection of that facility and issue a GMP Certificate only. The marketing authorisation applicant must highlight that this is the case so that an inspection can be arranged if required.

Further guidance and application forms can be found on our website:

https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences

I hope that this is of help to you.

Kind regards

Rick

Richard Parker
Senior GMDP Inspector
Inspection, Enforcement and Standards

MHRA, 10 South Colonnade, Canary Wharf, London E14 4PU

[lrdpdx77]

Not speculation there are contracts in place. As a thought experiment, would BP partner acquire CRL if they were NWBO's contract manufacturer at a price north of $800MM or would they assume the contract and have CRL manufacture the Vaccine. I think they would just assume the contract unless they wanted to bring manufacturing in house and become a contract manufacturer. This is really a silly discussion.