NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

Actually dmb2, I wasn’t being pragmatic. As you may know, after the ASCO manufacturing presentation last year, I was convinced that the Flaskworks’ Eden system had been qualified and was completing validation, and I thought it had been included in the automated process that Advent used for the commercial license. However, last fall, I was told by an associate (who talks to management) that Flaskworks wasn’t included because its development wasn’t completed by July, when Advent applied for the commercial license for Sawston.

When I saw the biosensors on the prototype system on the slides of the ASCO presentation, (after nearly 2 years of development time) I assumed that it was completely functional, (and mostly validated) but maybe it wasn’t. Flaskworks and Advent both hired some key personnel in September which appeared (to me) to be related to Flaskworks’ development. (Flaskworks hired for product development engineers whose responsibilities included “Identifying design improvements and integrating technology for monitoring cell culture to ensure reliability” and Advent hired for multiple computer validation, and software/firmware script writing positions) So, as of last fall, Flaskworks/Advent may still have been working to control the biosensors for the culturing/feedback parameters of the automated culture process, and the software integration with the Autolomous Manufacturing Execution System software at Sawston to control the Flaskworks system, and/or validation work on the biosensor controls. Perhaps a sense of urgency finally occurred last fall for the proper resources to get the Flaskworks system ready for the comparability study, so that it could be approved in time for commercial production by the end of this year.

I think marketing approval in the UK can be much faster than the comparable timeframe in the US that you’re referencing. In the UK, DCVax has been designated as a Promising and Innovative Medicine (PIM) for a rare and deadly disease with limited treatment options, so it qualifies for an accelerated review process. Many of us believe that it could already be in a rolling review, which allows modules of the eCTD dossier to be submitted incrementally for pre-assessment by the MHRA, rather than as part of a consolidated full dossier, and it also allows enhanced regulatory interaction and advice to reduce the risk of failure, and “the final decision on approvability reached by Day 100.”

I anticipate that Northwest Bio will announce the MAA filing when the final submission has been accepted by the MHRA. Northwest Bio is likely interacting with a very busy, and back-logged regulatory agency, and potentially may be working out a schedule, so that once the completed final MAA has been submitted, it can be assessed and approved within the MHRA’s 100-day window.
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If that is true, then I would anticipate regulatory approval within about 3 months of the filing announcement, but potentially up to 5 months, if there are issues that require follow up information. And by the way, that previously mentioned associate also thinks that approval in the UK will be very rapid.