Replies to post #691860 on NorthWest Biotherapeutics Inc (NWBO)

[antihama]

Doc, IMO, the artisan method approval is totally in play. That is the manufacturing process they used for the clinical trial and that should be good for approval. And not to mention, it is the process they are using for the Specials/compassionate use program.

[beartrap12]

Doc Logic, the best case scenario for NWBO has always been if DCVax-L approval coincided with Flaskworks automation validation, and now, because of one delay after anothr, it appears that may actually happen. A week or two ago I wondered if Sawston might be overwhelmed with patients from all over, not just the U.K., if DCVax was approved without Flaskworks in place. Now the first Flaskworks Eden unit is within weeks of being installed and shortly afterward hopefully being validated as the same product as the artisan method. We don't know if the latest delay is purposeful as Eden catches up, but the important thing is approval is coming soon. I had also hoped they would just approve the artisan method, but now that we know how long it takes for quality control to determine the treatment is good (3 weeks), maybe it makes more sense to wait for Flaskworks. Not that any of us wants that. Particularly the patients!
The 10Q also talks about delays in supplies continuing to be a problem. I wonder if some of those delays will disappear once we have approval. With UK approval, management can contract for the products they need per week or month, and the companies that supply them can confidently expand and add additional employees, knowing they had a reliable customer for their products. Of course, if there is a shortage of trained workers, we still might have a supply problem.