NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

No way to know, but that does not seem to be what the company has suggested. Plus, the notion that there is nothing new to going commercial with a highly customized production process is not really true. Clinical trial production over a few years was just 331 patients, plus some random patients for compassionate use here or there and some patients in one side-arm trial.

Getting approved for commercial manufacturing means having the ability to get hundreds of thousands of patient's samples and data and keeping it all straight. Putting the right cells together with the right tumor tissue, following the process all the way through, storing the doses appropriately over years and distributing each patient's dose as and when they need it to the right destination.

It's a completely different animal. It's very complex. And there hasn't been a considerable delay. They said the MHRA is still backed up. This is a novel product, like none other out there ever approved, in reality, though I know that is difficult for some to fathom. So yes, right now it's a few weeks later than would be normal in normal times, but so was the non-commercial Special approval weeks late. There were no Flaskworks machines then either, and that was a much less complicated task, but still ore complicated than the clinical trial potentially, if demand had been there. I would not jump to conclusions based on pure speculation therefore.