Finding an alternate CDMO may be a good idea, but an existing GMP facility is not automatically a DCVax-L/EDEN approved site. It would still require contracts, tech transfer, qualification, validation, QA/QC setup, chain of identity controls, release testing, MHRA acceptance, and the money to pay for it.
That matters because NWBO is already cash constrained.
And EDEN itself has not been publicly shown to be validated or accepted for commercial DCVax-L manufacturing. So before talking about bringing EDEN to a third party site, NWBO would first need to show EDEN is validated, that EDEN-made product is comparable, and that the process is accepted by MHRA. Only then does the third party site question even become meaningful.
After roughly 2.5 years in MHRA review, the delay has to be somewhere. If DCVax-L works “without a doubt,” then the delay would seem to point toward manufacturing, CMC, validation, comparability, release testing, site readiness, or some other part of the manual artisan process. If that process is still unresolved after all this time, why assume validating an automated commercial scale process at a third party site would be quicker or simpler?
So I do not see a third party manufacturing site as a chip shot. “Continued discussions” means they are still talking. The hard part would still have to happen. Unless there is evidence that tech transfer, validation, site qualification, and MHRA acceptance are already underway, this looks a long way off at best.
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