Zadie, it's a simple fact that without the EDEN, only 20 tiny cleanrooms are producing 50 batches of the vaccine annually, for a grand total of 1000 batches a year. What good would worldwide approvals do if only 1000 patients a year could be treated.
More capability must be available by the time the approval is granted and I believe it cannot be submitted until you have equipment approved to produce it at volume, in our case, the EDEN Unit.
I believe an application could be submitted if approval of EDEN was anticipated roughly 3 months later. That would allow for an inspection that's in line with the 6 month PDUFA date the FDA establishes after accepting a BLA submission. I don't know that the company would gamble on getting such an approval in the future, but it is a decision they could make.
Can you imagine the chaos at Sawston if worldwide approvals were granted with a tumor agnostic label and Advent was the only supplier and they could only make 1000 batches of vaccine a year. Who in the world would get one of 1000 batches when there were millions who wanted the vaccine. With a tumor agnostic label I suspect well over a million patients would want the vaccine. Remember, currently over 300,000 new patients are found to have GBM annually, that number would be multiplied many times if you simply added some of the other deadliest cancers. Pancreatic cancer alone adds over half a million.
Gary
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