HL,
I know they've never clearly stated how long it would take to gain approval of a FlaskWorks based commercial production facility, but I believe that it's been clear that it's the critical path toward approval. Their application for inspection of the production capability in the U.K. I believe marks the fact that everything is falling into place. The key will be the acceptance of that facility.
I know it's just the U.K., we really don't know if the other three regulators will agree. The FDA has been know to hold up approvals for substantial periods of time while waiting on changes to the production facilities to be made, these facilities had often been approved by inspectors from other regulators. I just hope that the facility is acceptable to the FDA and others and can be duplicated in sites in the other countries required to market DCVax-L in those areas of the world.
While it would be thrilling to find we have all four regulators working together and all will approve simultaneously, I really don't believe this is the case. I can't say our FDA will be last, but their track record makes the odds of that pretty good.
Gary
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