Replies to post #753471 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I'll repeat again that you cannot apply until you have a commercial production facility that will be ready for inspection by the regulator. The company doesn't have any such facility until such time as the EDEN can be used to make the vaccine.

20 tiny cleanrooms in Sawston don't constitute such a facility, they're adequate to get the UK started, but not the US or other more populous places.

If I'm right about 20 cleanrooms, each one is capable of making roughly 50 batches a year. That's 1000 total patients that could be treated in one year. Currently according to Google there are over 300,000 new cases of GBM annually worldwide, 1000 is less than the rounding error. It may be enough to get the UK started, but demand should require the EDEN there very shortly as well.

Once we've learned when approval of the EDEN is anticipated we'll know when filing with other regulators might be anticipated.

I'm not saying EDEN approval must occur prior to filing. I'm saying that it must be approved by a few months into the process when inspector can check the commercial production facilities. Clearly the company would need to be practically certain of EDEN approval before filing with one or more regulator.

Gary

[Investor082]

Understaffed, are you kidding me? The reason why they took over 3 years to submit MAA and double/triple check the application before submitting to the UK was so that they could apply to multiple RAs. They simply lied to investors at that point.

When your existence and ability to turn profit depends on US approval, you do whatever it takes to submit an application and not come up with excuses. This is why no credible institutions would back them.

They won’t be able to hide anymore. The lies and dangling of carrots catches up soon.

[dennisdave]

One reason could be that they're understaffed and unable to handle both agencies at the same time.

They are understaffed BUT are able to pay for the salaries of 85 highly educated staff at Advent Ltd a Toucan subsidiary? That would have been hilarious if it weren't so tragically corrupt.