In my own experience with submitting approval documents to a local governmental authority having jurisdiction on a project I was assigned to, oft times I'd get back a rejection when one was not deserved, only then to find out that they were too busy to get to the review- so they kick it back out.
My point here is, I believe the NDA has been accepted for review and as you noted the "clock" started clicking when the application was received. The PDUFA date is a target that could come sooner or later.
Tigrdog (Rik) - yes, we need to get Koufax over here so kudos on your message post on the carnival venue!
jab9
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