Thanks Biosect,
For both your recent answers, clearly you know far more than I do. As I understand it, by the end of the six months the regulators allow for evaluating the BLA you either need to have an approved production facility, or they'll issue a document extending the period I believe it's called a CRL.
I believe they're smart to know that they'll have the production capability approved prior to the PDUFA date. While I believe they could gain approval before that date, if there manufacturing is still incomplete they'd give them until then to complete it. I think that on occasion they move the PDUFA date without giving the specifics as to why, so it's not always the CRL.
I hope you're right about a clean room being able to handle more than one person's vaccine at a time with the conventional methodology, many in the past have made it sound like that was the limit. I gathered that at Sawston they build rather small clean rooms, and lots of them, but I don't know that to be the fact. Hopefully each room also has sufficient power, climate control, etc. to be adapted to handle multiple FlaskWork units as well.
Gary
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