Replies to post #529270 on NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

Thanks for posting your view. I think what you’re trying to say is that a wise company must be prepared, and they must lay the groundwork for manufacturing in advance of regulatory approval. In fact, the capacity to produce the drug is required by regulators. Quite simply, we are living in a new era of cell-based technology. The rapid growth and expansion of the capacity to manufacture cell-based agents is crucial. Any company aiming to commercialize successfully and not be left behind must be prepared to scale up production. CRL recently acquired Cognate Bio and NWBO recently acquired Flaskworks. Those on the cutting edge of this new field of science are preparing to address a global market.

https://p.widencdn.net/ud1zkk/DS-TS-immunology-dendritic-cells-activation-assay







https://www.cnbc.com/video/2021/02/23/charles-river-laboratories-ceo-on-unprecedented-drug-discovery-demand.html

https://virtualtrials.org/dcvax.cfm

[dstock07734]

The management cares a lot about shareholders. That's why LP has been treading very carefully. She knows first hand why NWBO ends up on OTC market which is a tough place full of vampires and vultures.

[Doc logic]

HyGro,

The MIA approval (commercial scale manufacturing UK) must happen BEFORE MAA approval. FDA also requires proof of ability to ramp up to expected demand levels before any BLA can be approved and that proof can be submitted during the course of a rolling BLA application especially if one method is being exchanged for another during the submission period leading to a completed BLA.
The building and use permit at the Memphis site for Cognate/CRL has publicly established plans for a massive expansion next year in line with expectations for an approval of a new, high demand cell based product. Commercial scale readiness has been moving at a rapid pace ever since the time that the company would have been unblinded which is also the time when loans were granted to NWBO for funding of ongoing operations. In days to months what is obvious to thousands will be obvious to millions which means no stopping NWBO then. Best wishes.