You all sound like the little boy who cried wolf, then realized it was a mouse. Let it go people, we will get approval when we get approval. Stop the dribble, its tiresome. Sell if you cant stomack it, hold if you believe. Nuff said!
Sir Duke Your FDA comments. Are they - Speculation, interpretation or direct experience? I do not know when the FDA calls meetings. If they want to tell you something they have guidelines that call for written communications. Meetings are for....issues regarding the review that cannot be resolved by email, facsimile, or telephone calls. Issues. Just what are these "issues"; technical, commercial, documentation? We are waiting to hear.
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