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My understanding is that the FDA have a goal of responding to...

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    My understanding is that the FDA have a goal of responding to all ODD applications within 90 days.
    (https://www.fda.gov/media/106012/download)

    Presumably all applications go into a queue and are seen to in the order they are received.

    Our initial application took 59 days to make it through the queue. Presumably once additional data was submitted the application returned to the back of the queue.

    Assuming the queue length hasn't changed much in the last 5 months, we should have a response pretty soon. Next week perhaps?

    Is this how the system works?
 
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