Tuesday, July 27, 2010 1:32:59 PM
Possible answer: Seems to me if the FDA requested two images then the smart thing would be to send only the requested images... not a "whole new" 1200 pages with the promise that only two things had changed. A responsible FDA reviewer would then be forced to review the entire document to assure that nothing else had changed.
Like most, I'm here til the end... but there are just too many fish in this barrel.
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