Sorry for the confusion. I don't know when the new FDA team took over NEPH. Perhaps someone could pop over to the NEPH Board if there is one and ask the folks over there if they know. I only know that we got a new team in late fall 2009 and that it was part of a major overhaul at the FDA. Presumably NEPH was in the same boat as Imaging3 because the entire review division of the CDRH was shaken up from top to bottom. The January request we received was the 1st request from the new team. They took over the application in late fall, and got a formal AI request back to Imaging3 within 90 days with the first formal AI Request. We responded and are now on the verge of 150 FDA days since the response.
I don't know the history with NEPH. In particular, I don't know when the new review team took over, but I do know that a new review team had to have taken over, because the old reviewers were replaced. When that happened specifically, and what communications they had with NEPH after taking over, I'm not sure of. But it makes sense to me that the FDA is not counting the long history before the new review team took over.
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