NorthWest Biotherapeutics Inc (NWBO)

[beartrap12]

Doc Logic, I believe MHRA needs to see that our Flaskworks Eden units work before we get a green-light for MAA. I don't mean Eden needs to be hooked up, validated and running. I believe MHRA already knows it's getting done. The question is, how long will the tweeking take? A month? A year? In the February PR we were told that they had chosen a company to make the Eden units GMP-compatible and it talked like it would take several months to build it. I thought we were ready to go into production, but obviously there have been things that needed tweeking and changing on the prototype. We're obviously there now, with the very definitive statement they made in the 10Q:

The design work to make the Flaskworks system GMP-compatible was completed.

The question now: will the company wait to produce the Eden units until the they have reduced the footprint? Antihama suggests that's for next year's model and I'm beginning to agree. It just doesn't make sense to me that they would build the GMP-compatible unit, tell us it's done, then decide to re-design it as a smaller unit.

So, I'm ready to hear that the first unit will arrive in X-number of weeks or months. Or better, that it has arrived and is hooked up and ready to go through validation runs.

When will MHRA decide we're close enough to confirm our MAA? Are we there yet? Or does MHRA need to validate the first Eden before we're close enough for MHRA to make a decision on our MAA? Or maybe I'm wrong and MHRA is not paying attention to when Eden becomes available. I think they are.

Linda said we would begin with the artisan method and I believe her. But I think both NWBO and MHRA want the Eden units up and running in a matter of months, not a year, after marketing approval, which I feel sure they get. I say this because the UK, according to statistics, has about 1,500 new GBM patients a year. The artisan method will only handle about 500 per year. So without Eden units up and running, we immediately start out overwhelmed in the manufacturing of our product. If it's just a few months delay, it's not as much an issue because all new products have a run-up to fully operational, but longer than that and we start to look like the little biotech who failed and our price dips before we have a chance to get off the ground and running.