Replies to post #363746 on NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

Just to finish the thought:

Advent BioServices Agreement
On November 8, 2019, the Company and Advent entered into an Ancillary Services Agreement with an 8-month Term for the U.K. Facility Development Activities and the Compassionate Use Program Activities. The Ancillary Services Agreement establishes a structure under which Advent will develop Statements of Work (“SOWs”) for each portion of the U.K. Facility Development Activities and Compassionate Use Program Activities, and will deliver those SOWs to the Company for review and approval. After an SOW is approved by the Company, Advent will proceed with or continue the applicable services and will invoice the Company pursuant to the SOW. Since both the U.K. Facility Development and the Compassionate Use Program involve pioneering and uncertainties in most aspects, the invoicing under the Ancillary Services Agreement will be on the basis of costs incurred plus fifteen percent.

I believe the Statements of Work (SOW’s) were to get Sawston certified by last summer and begin producing a small revenue stream under the UK Specials Program, while establishing commercial processes using the MicroDen system. Eight months from November 2019 was July 2020, but the construction was delayed due to Covid. From the 10-Q, Q2 2020:

Advent BioServices Agreement
The Company has a Manufacturing Services Agreement with Advent BioServices for manufacture of DCVax-L products at an existing facility in London, as previously reported.  The Company also has an Ancillary Services Agreement with Advent, which establishes a structure under which Advent will submit Statements of Work (“SOWs”) for activities related to the development of the Sawston facility and the compassionate use activities in the UK, as previously reported.  To date, Advent has not yet submitted SOWs and the Company has not yet made any payments for these Ancillary Services. The Ancillary Services Agreement had an original term of 8 months, ended in July 2020. On August 7, 2020, the Company extended the term by 12 months, and did not make any other changes.

These were my thoughts last fall, and I was anticipating certification in March or April this year:

hyperopia   Thursday, 10/08/20 01:09:46 AM
Re: kabunushi post# 315196

Post # 315201 of 363225 
right kabunushi, we don’t know the details of the Advent services agreement. I posted that to show that the SOW’s for “activities related to the development of the Sawston facility and the compassionate use activities in the UK,” was not completed as expected by July, and it was actually extended on August 7th for an additional 12 months. That tells me that although there is a mid October completion date for phase 1 at Sawston, the facility will not be ready for manufacturing until well into next year. You’re probably aware that there were additional disclosures in the 10-Q that no compassionate use manufacturing occurred during Q2 due to lockdowns, travel restrictions, and personnel under lockdown, and this could be halted again if they’ve been restarted during Q3 and Q4. I suspect that the cell characterization and optimization work that needs to be done to produce DCVax on the MicroDEN system can’t be started until the phase 1 construction has been completed, but Advent personnel may have to prioritize the backlog of compassionate use cases over this work. What do you think?

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=158770796

So now my guess is Sawston is certified in June or July, and commercial readiness will be achieved shortly after that.

[Basin Street Blues]

Three moving parts :

The meeting of various endpoints

Agreement on added value of D

Legal and Compliance related loose ends

Regulators changed endpoints to meet our SAP , so probability of approval will be far
higher than JUNO & KITE and just about any other pre approval buy out I can think of and Merck know that far better than us.

The deal is done.