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Trader
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ABIO's date is expected to be today (Sunday) and HEB's original date was on 5/25 (Memorial Day). What gives?
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UberTrader
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They just give a date 6 or 12 months from filing date, or 3 months from a 'delay' announcement. I don't think they actually look on a calendar as to what day those land on. If it's a holiday or whatever it's probably understood that the deadline is the next working day.
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Trader
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Does the FDA have set in stone rules about giving a response on those time frames you just mentioned, or are these just ballpark estimates?
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UberTrader
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As far as I know they must issue some sort of response within the time frame. Whether it's an approval, denial, extension or whatever.
Someone mentioned in the HEB thread that by law they have to give some sort of response by the date, whether that is accurate I'm not sure. |
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