NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

Manufacturing Timeline(s)

In the UK

Paul Grundy, NHS England - Chair of Specialised Adult Neurosciences Transformation Program

...have to take a step back and look at it from a global funding perspective...

NWBO PR about Sawston Commercial Manufacturing Certification:

Following completion of any post-inspection actions, the Company is hopeful that a manufacturing license for commercial production of cellular products in the Sawston facility may be approved by year-end.

In the USA

Richard Pazdur, FDA, Director of Oncology Center of Excellence

...when you have a truly important breakthrough therapy drug, it is important that it has relatively widespread, worldwide distribution...

Cognate, now Charles River Labs (CRL), applied for a $57 million grant / tax abatement from the City of Memphis Edge PILOT program back in November 2020. Primarily to increase its manufacturing, warehousing and distribution footprint at their Memphis facility from 88,000 SF to over 250,000 SF. Almost tripling in size. This major expansion will include dozens of new clean room suites, and there were only 2 companies directly mentioned in Cognate’s application to help support and explain this expansion: Northwest Biotherapeutics and Atara Biotherapeutics. (cite below from ATLnsider)


In a December 10, 2021 CRL correspondence it was stated:

Their communications person checked with the Memphis site director, and told me that (1) no changes are planned to the original expansion plan that was awarded the public incentives (2) 4600 Shelby Drive is now undergonig expansion construction to double its size and that work should be completed by late 2022 and (3) the space at 6100 Global Drive will be used for additional capacity required for making personalized therapeutics.

(cite below from Lykiri)

Thoughts + Wild Speculation:

We have heard from top level opinion leaders in the UK and USA showing the importance of global manufacturing/capacity. We see an end of year goal for UK manufacturing certification. We see a potential "late 2022" completion to US manufacturing capacity at CRL. The US buildout was reconfirmed less than one year ago, in December of 2021.

I shouldn't speculate this wildly, but here goes:

1. I believe NWBO thought the JA would be out by now and it has been delayed for whatever reason. See Dave Innes comments about earlier ASM (going to have one in July and then September). I believe NWBO thought the JA would be out and they could hold an ASM after the JA. No JA, no ASM (to date).

2. I believe NWBO has ALWAYS targeted late 2022 for BOTH US and UK manufacturing capacity.

3. I believe approvals for BOTH the MHRA and FDA will come shortly after commercial manufacturing readiness.

4. I believe we are looking at parallel approval processes going in both the US and UK with approvals happening Q4 of '22 or Q1 of '23. Think Project Orbis.

5. I'm not as warm on EMA progress as I've seen nothing about further filings on their website (such as the PIP).

Cites

Big thanks to ATLnsider & Lykiri for sharing the following information cited in this post.

ATLnsider - https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169565138

Lykiri - https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169574952&txt2find=memphis