The off label demand argument seems backwards to me. NWBO does not even have the initial label approved yet, and there is still no clear evidence that they can manufacture enough product for the labeled population at commercial scale.
So why is expanded off label use suddenly part of the story? That sounds like jumping several steps ahead. First you need approval. Then you need a validated commercial process. Then you need capacity. Then you need reimbursement. Off label demand is not the starting point.
Specials may show that some physicians and patients are interested, but it does not prove broad commercial demand, and it certainly does not prove that regulators are planning around expanded use beyond the initial label.
I also do not read preparation itself as proof of approval. For a product like DCVax-L, manufacturing readiness is not some optional post-approval detail. It is part of the approval problem. NWBO may have to show that the manufacturing process, staffing, facilities, quality systems, and capacity plan are in place before regulators are comfortable approving anything. That does not prove approval is imminent. It may simply show what still has to be demonstrated before approval can happen.
Manufacturing and capacity buildout may simply be prerequisites for approval, not evidence that approval is imminent. Some things have to be in place before regulators let you proceed. The cost of adding lifeboats to the Titanic only proved that even an “unsinkable” ship still had to meet requirements before it could sail.
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