I strongly disagree. This is a device, not a drug. DD by other members has revealed that our type of submission, without requests for further data by the FDA, averages around 180 days to decision. Also, this is the 2nd submission by AMIC for the same device. Remember, last year they submitted this under Class III, and that submission was back in Feb.-March time frame I believe. So any prediction of a late fall approval is WAY off base IMO. And in a conversation I had with the FDA about a week or two ago, they confirmed that 120 days is mandated to "fast track" de novo submissions in order to get them to market. That's the entire purpose for the de novo program. They can go over, but not by a year.
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