Sunday, April 21, 2019 10:38:03 AM
We are approaching the 60 day mark on the FDA timeline which will be on or before the end of April. The clock starts after the administrative review and on to substantive review. Will the clock stop for either or both submissions? nobody knows! FDA response at best without the clock stopping will be at the end of May, if stopped we are looking for June responses.
Have a nice day.
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