I disagree, but this is one of those points that can never be proven because the FDA is going to respond when it responds regardless of how it treats an application, a response or a question. We are in the Fast Track Program. The FDA told Dean we are in the Fast Track Program. Regardless of whether you are in the Fast Track Program or not, the FDA's guidelines say that minor inquiries made by telephone or email to which the applicant can quickly respond do not stop the review clock. If such an inquiry does stop the review clock, then the FDA needs to send a letter to the applicant in writing saying that the clock is stopped. The types of questions asked by phone and email in late April are the exact types of questions used as examples in the FDA's guidance documents as the type that do not stop the clock. Regardless of whether the clock stopped or not, and whether we have hit 90 days or not, it doesn't matter because those are only targets/goals anyway. They could have stopped the clock and so we are not at 90 days yet and they could still give an answer today. They could have kept the clock going and we are at 97 days and we could still get an answer today. The fact is, regardless of how many days into a review cycle we are, the types of questions the FDA was asking, and how long ago they were asking them, all indicate that a positive response is likely and any response is likely to come soon. In my opinion, we should have already had the response, but I still think it's any day.
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