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Ann: FDA Strategy and Regulatory Update, page-38

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    Mate on Day 60 FDA start the 'Substantive Review' Process which normally takes 30 days.The outcome of that 'Substantive Review' process is a Decision which than communicated to company and published on their website. That is what I understand. As you can see we are already in the review process and 7 days already been passed so a decision could come within or less than 21 days. GLTAH.
 
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