Since FDA has not officially started review, are we at 'By Day 60' state or 'By Day 15' state?
If we are at 'By Day 60' state, then it will take another 30-40 days once FDA officially starts review, otherwise there may be another 75-90 days' wait.
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- Ann: FDA Strategy and Regulatory Update
Ann: FDA Strategy and Regulatory Update, page-101
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