While I do believe that Flaskworks and other capabilities will be extremely important to commercial scaling and it is definitely important to get expedited approval and therefore into programs like Project Orbis to have a plan for scaling, I disagree that there is some sort of disregard for the issue and that it is this issue that is holding them back from disclosing TLD or publication. Also, the FDA has approved Car-T related applications with very limited scalability and extremely high cost.
So while manufacturing enough can be an issue for attaining a new SOC status, and that is why accelerated approval is basically limited to companies that can scale to become SOC, or at least that have a practicable plan to do so, not that they have it all in place when the FDA accelerates approval, it is not a reason to deny approval.
I follow companies that have been denied approval for manufacturing reasons, but in those cases the issue was that they had a product that could not only not scale, but could not be made consistently and distributed consistently as a product, and the product was not customized, so the failing of the manufacturing process in my opinion is almost a catastrophe, even though I made very good money when I got out of that stock, entirely, and their trial results, though without a placebo, were quite good.
I do think the FDA is careful with cell therapies, but there has been no suggestion that NWBO is experiencing those kinds of issues. I agree that the scaling plan will be important for accelerating approval and they may be proceeding carefully therefore in their validation process. I just do not think it is exactly as some say. I also think NWBO would have had Flaskworks machines whether they bought the company or not, but owning the company and patents makes it much, much more valuable. So that is a different issue in my estimation. Huge victory for shareholders, one less other company to sustain to get to commercialization.
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