It depends on if they are granted fast track or not. If they are it speeds up the process. They could conceivably file a BLA with rolling review in under a year (I've seen as fast as 6 months) and regulators would receive portions of the BLA as they are completed, thus speeding their review of the material. I've seen FDA take as little as 6 weeks from the time of completed BLA filing before coming to a decision (actually is was a NDA). But that was one with rolling review. The range is vast, though, and it could take upwards of two years or even longer. And yes they must show they have capacity before regulators will give them the green light. They must examine the same facilities they will commercialize from. I believe this is where DNDN ran into so many issues.
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