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Ryoko

06/09/19 10:37 PM

#5399 RE: ElevenWall #5398

Seems unlikely that the FDA would ask for more info. As another poster had mentioned, SESN has already held a number of meetings already, presumably coordinating what data they expected from the clinical trials. I'm not sure when the meetings took place. But there is a process where the FDA reviews clinical trials as they are happening. The result is that when they receive the BLA, most of the review is already done which speeds the BLA review process in the end. I don't know if that's what happened here. But it would be a welcome development.