Tuesday, September 28, 2010 2:01:48 PM
You would think if they had any major questions then they would've sent the application back with Dean to make corrections. But it appears they have no issues whatsoever according to Dean.
When does the point come when Dean says to the FDA: Look it's been x amount of days so whats the verdict? Can he go over the reviewers head and contact the director to find out what's going on if this continues down the same path?
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