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beachhyena

12/02/21 7:48 PM

#423517 RE: Gus McCrae #423508

Maybe just maybe a contract between NWBO and Cognate/CRL is not required at this point. I say this because NWBO has gone into a self imposed quiet period and it looks like they are proving that they will have capacity to start manufacturing very shortly in the UK albeit for specials only at this point. More importantly I believe work is also being concurrently advanced with Flaskworks per recent posts by iwasadiver. The companies goals have certainly changed since they acquired Flaskworks and they must believe this is the way forward.
When DCVAX-L meets full approval here in the US sometime after topline and publication I believe they will be in a better position to assess how they meet demand, and if they do indeed need CRL will renegotiate at that point.
We also have the outlier that may still be in play and that is a partner is waiting in the wings for NWBO to reach a number of set goals before they step in, some of these goals may involve Sawston/Flaskworks/Publication/TLD etc. Flipper has outlined many of these goals and events within the oncology space that have been highlighting the growing importance that a new paradigm to treat GBM is revealed in short order. JMHO.
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Doc logic

12/03/21 11:11 AM

#423630 RE: Gus McCrae #423508

Gus McCrae,

“Other regions” would make no sense to include North America except as patient paying Specials Program patients. The issue with even this idea is that the Flaskworks device that iwasadiver has told us is in equivalency testing now, which makes sense, still might not provide enough initial capacity, based on current buildout, to meet initial demand for all of Europe let alone North America and rest of world medical tourism even at 500 patients per month treated at Sawston. There is a significant amount of initial demand that would come from GBM and rGBM patients.
Bottom line is the whole process is probably in silent mode as capacity is increased in anticipation of worldwide SOC demand, not only for GBM but also off label. Contrary to what I have said before, the validation “process” may actually be helping NWBO/Sawston/Cognate/Charles Rivers Labs buy time to get manufacturing up to speed for this challenge although it probably could have started sooner under more updated regulatory and peer review conditions. Could more patients have been treated on a limited basis using the old methods during this time if NWBO and others could profit a little more along the way? Probably but Covid definitely would have impacted even a better opportunity like this had it been in existence.
Bottom line is that every day that goes by the more compacted the eventual news cycle becomes making the news more explosive when it arrives. If you don’t know what to think then be prepared for an active vs passive wait with regard to your investment. For me, that means buying more at certain price points. Best wishes.