These are very good points, gentlemen. The FDA takes its performance against its internal goals pretty seriously, but they just need to justify to themselves and to Congress that they are meeting those goals. So they could easily "make the decision" within their guidelines, but not communicate for a few days. What we have seen lately is that applicants ARE HEARING within (often right at) 150 days, but there is no deadline for them to communicate the decision. They will not report it publically before communicating it to the applicant, but they do not have the same SEC-driven 72 hour requirement that Dean has. These days they are most often communicating SE determinations to applicants by fax, so it stands to reason that we'll know very shortly after they decide, but there is no guarantee of that. While I believe Sept. 8 is the 150th day, I'm looking at next week in general as when I expect to hear. Or today.
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