TD, thanks. The take away when I talked last week with Jack about the very same subject, was that at the end of the day, the FDA is somewhat of a wild card - in the sense that the timetables are goals that they do have and sometimes, if the agency or particular reviewing committee assigned to your particular NDA doesn't have enough time for the thorough review, they then will issue a "cover you rear end" type of letter which is disguised as a "RTF" (refusal to file)or to request more info. But he did say they hold true to the initial 60 day 'filing review' time frame.
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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