There is no ambiguity in these situations. The FDA's guidance is crystal clear, there are only three instance in which the clock is stopped: (1) final determination (SE/NSE), which is communicated by a formal clearance (or NSE) letter; (2) an informal request for additional information followed by a formal "hold" letter; and (3) a formal written AI Request. There is no room for interpretation by the applicant or the public. The clock only stops if there is a formal written communication from the FDA stating explicitly that the clock is on Hold or stopped because of a formal AI request.
On the last conference call, this exact question in those exact words was put to Dean and he answered as clearly that he had received no written hold letter, no written AI request and no other communication from the FDA informing him the clock had stopped. Dr. Polk just posted that Dean even explicitly asked the reviewer if the clock had stopped and they said no. This is not a matter of dispute. It is resolved. That being said, it doesn't guarantee anything will happen at any given time. The clock is still ticking, the clock has passed 150 days, the clock will keep ticking until we hear. Dean is not hiding anything from anybody. It would be one thing to wonder about that in a vacuum, but when the question was put to him directly and clearly with no wiggle room, he answered it just as clearly... he had not received any written request for AI nor had he received a "Hold" letter. When this process is completed with the FDA, those communications with the FDA will be available by FOIA, and if he was lying in answer to those questions, he will be ruined. He knows that, and hence, he would not lie.
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