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quimper27

10/18/13 11:18 PM

#18105 RE: wmjenkins3938 #18103

They could send the letter a month from now. that letter is part of the review process. They are under no obligation to finish by pdufa date. The decision gets delayed. Happens all the time. I am not suggesting it will be delayed, only that it can be delayed.
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quimper27

10/18/13 11:20 PM

#18106 RE: wmjenkins3938 #18103

And having a meeting does not mean they will work out their differences. Having a meeting is the first (and maybe only) step in the dispute process