NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Hi Gary, I do not think that approval will be delayed for Flaskworks. If Flaskworks gets approved sooner, that's great, but the commercial manufacturing approval is pending without Flaskworks. Everything right now hinges on that commercial manufacturing application in terms of timing of the next step, application for the BLA both in the UK and elsewhere. If the company has expressed a desire to use the ILAP program to ultimately get into the Project Orbis program, then very likely the MHRA is making sure that the factory will be acceptable for that program, meaning for all the other parties.

I expect that NWBO will contract with CRL to enable delivery of cleanroom capacity as a stated growth plan will require, and that such a plan will be submitted to the relevant regulators. It may require an immediate agreement, but possibly with an initial capacity that may not be the full capacity they may require, but with plans to scale up, thus incurring more costs on a reasonable basis. You don't have to have production for years from now immediately available today to get approval. You need to have a workable plan, as in providers like CRL, under Contract, where the agency is assured that there is a reasonable scale-up plan that can be accelerated IF you need the production for rapidly expanding demand. With such a plan, I anticipate that they can grow production reasonably fast to meet that demand. But getting Flaskworks up and running will allow them to adapt that plan as well and to scale with that production rapidly. They don't need to have Flaskworks approved before applying or before approval, but they do need their initial production factory approved and the ability to make the necessary reassurances that there is a plan to address expansion of demand and that it can be acted upon in a reasonable amount of time to address what may come.

I think they are putting that into place.