On the last submission, from what I understand, it was just a labeling issue that held things up. Are there any other issues that are of concern? I know that there have been phone calls between the FDA and Dean with more questions that he answered. If he has answered the questions and the labeling issue has been addressed, what is left? Why would the FDA call Dean and be asking questions? Does the FDA give that benefit to the submitter in lieu of giving a flat denial? We are obviously close because I don't think they would bother calling Dean with more questions if the DVIS was not what he said it was. Based on what I see,things look more positive than negative. Am I off on my thinking? GLTA
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