Don't you agree HB delayed the "complete" NDA on purpose...
Why would he file 99.5% and wait weeks to file "routine CMC data"? We have been preparing "minor, routine, technical" parts of the application for almost a year now.
I think HB intentionally delayed a complete filing to ensure our launch ready date of October 31st happens prior to early approval.
And so why would we be launch ready on October 31st only to carry those expenses for several months into mid-Q1'13?
Because....a mid-September complete filing starts FDA 45-day clock to receive Priority Review by end of October followed by early approval by Thanksgiving.
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