NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

I agree with senti, that the delays in the submission of the marketing application, delayed the timing of the approval of DCVax, which made it months closer to the potential approval of the Flaskworks’ process. I also agree that the wording of the press release seems to back this up, particularly this line:

The Company believes that the Flaskworks system will play a central role in enabling the efficient and timely scale-up of manufacturing to make DCVax-L products for large numbers of patients, and in reducing the manufacturing facility costs.

The company hasn’t guided any timelines, so how can it be a bait and switch? There are three independent timelines; one for commercial approval of DCVax, one for NICE reimbursement, and one for Flaskworks process approval. They will likely occur in that order, and potentially reasonably close together, so it’s not necessarily inconsistent with a 150-day approval process for DCVax.

For many of us, it’s not about being right or wrong, and we’re open to the possibility that commercial production begins with the current manual process, but it’s certainly possible, depending on the timing of the Flaskworks approval process, that the company begins commercial production with the Flaskworks automated process, for a number of reasons, including economic feasibility.

I know that everyone is anxious for commercial production (and revenues) to begin, and probably no one is more anxious than desperate glioblastoma patients, and Northwest Bio’s management, but generally commercial production doesn’t begin immediately upon approval as you seem to be advocating. There are usually insurance reimbursement issues to iron out, inventory and supply chain to build, physician awareness campaigns, hospital procedural training, and other preparatory activities after approval, before commercial production actually begins. So yes, that all could align with a “timely” Flaskworks process approval.