Way too speculative. I think the explanation is much more simple. Complicated trial and analysis, major publication takes time. That’s all there is to it. In parallel they are working on manufacturing and maybe BLA. But to suggest the FDA is that involved as you say is highly doubtful
If in fact NWBO cannot qualify the FlaskWork unit in time, I believe the company does have a fall back position. I believe that CRL and others have extensive clean room capability that can meet anticipated initial demand. I don't believe it's what they want to do, but I do believe it's a possibility.
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