Jmcll, It depends on what type of approval we g
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Posted On: 01/16/2020 7:16:21 PM
Jmcll,
It depends on what type of approval we get. Worst case it gives us a shortened path to approval by reducing the trial requirements. Best case (unlikely) we receive an unconditional approval that allows us to start selling immediately.
There are several options in between these two. We may get a conditional approval, or a customized (shortened trial) (ie FDA may request 20 patients over 12 weeks)
It depends on what type of approval we get. Worst case it gives us a shortened path to approval by reducing the trial requirements. Best case (unlikely) we receive an unconditional approval that allows us to start selling immediately.
There are several options in between these two. We may get a conditional approval, or a customized (shortened trial) (ie FDA may request 20 patients over 12 weeks)
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