NorthWest Biotherapeutics Inc (NWBO)

[ADVFN_doclee]

I cannot honestly understand why the regulators conflate efficacy with production. If DCVax-L has been shown to work in the Phase 3 trial using a manual method for production, that is something that the regulator can licence for use without any undue delay. Of course, it must also satisfy itself that the commercial production of DCVax-L is safe and reproducible for every single dose of the vaccine.
To that end there should be nothing stopping the Regulator from licencing DCVax-L for use provided that it is produced by the manual process. This will allow some patients to access the treatment now and not have to wait for some time in the future.
When the closed automated system is perfected and found to produce an adequate vaccine, the Regulator can then licence that production method as well.
Its not rocket science!