PM,
The printers aren't delaying anything. If they're submitting in a rolling manner they continue to do so as sections are completed. If they're submitting the entire application as a singular document it's probably done electronically, but even if printed it can't be submitted until they have a commercial production facility ready for inspection. They've submitted for commercial inspection in the U.K. utilizing many individual cleanrooms, but it's pretty clear that all other submissions will be based on FlaskWorks for commercial production and that cannot possibly be submitted until they have approval of the FlaskWorks unit to produce the vaccine.
If your looking at the FlaskWorks like they're a printer, it's true, they may not be any more complicated than a high quality ink jet, but proving that their output is as good or better than what's produced in a clean room is as easy, or difficult as regulators choose to make it. Ink jet printers with the right paper stock can make currency that's nearly impossible to detect is counterfeit, yet they can be detected. Proving that what we produce is not counterfeit DCVax-L when using the FlaskWorks unit is up to those inspecting it, regardless of how certain the company is that it's the real thing, the regulators have the last word. I would hope that we gain it's approval by mid-year or sooner, but I know the regulators can take 6 months to decide how to make 4 minute eggs.
Gary
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