Your analysis is totally contrary to the facts. The reality is, the longer it takes, the less likely it is to be bad news. Look at the data that Guru has posted, or look at the FDA's website if you have reason to doubt the accuracy of his numbers. NSE determinations are made quickly, SE, particularly in hot button industries like radiation emitting devices, takes time.
Remember this, just because something takes longer than you would like it to take, doesn't mean it's delayed. You ask why the delay in SE, and I say, what delay? I wish we would have heard by now, but what delay are you talking about? The FDA has not come back and asked more questions, which would be a delay, they have not sent a "Hold" letter, which would be a delay, and they have not come back with an Additional Information action request, which would be a delay. So I ask, what delay are you talking about? We are 3 weeks short of the longest time the new FDA has taken, which was over 180 days, at the end of which was a determination of SE for a radiation emitting device. In the mean time, we have received no bad news from the agency. To the contrary, we have been told twice now that they did not have any additional requests or questions. We see on their process review flow chart that we are at the final box, and that what the FDA expect to satisfy that final box is a review from a radiologist in exactly the same form as Dean sent them.
I wish we would have already heard by now, too, but that doesn't mean there is a delay and it absolutely doesn't mean a "bad indicator," since every single one of the NSE's reported by the FDA since the new FDA team has taken over, have come within 60 days of the submission and did not involve back and forth exchanges b/n the review team and the applicant. We'll hear when we hear, and I'm betting big on SE, especially based on the way this review cycle is playing out.
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