Seems the U.S. procedure...
is a lot more arbitrary than the European. Although, even with the prciseness of the European model one never knows the ammount of delay periods requested by the applicant. For instance, we are not certain if Arena has, or has not, requested a 30, 60, or 90 day delay for its oral presentation to CHMP. I noticed that Vivus requested a delay in the European process and issued an 8K but we can only assume that since we have not seen an 8K we are on schedule, but that may not be necessarily true.
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