Re: This proves that I have too much time on my hands...
in response to
by
posted on
Jan 09, 2013 08:07PM
Edit this title from the Fast Facts Section
Stizzer,
It's nothing to worry about.Al said a year or so ago that the only trial necessary for approval is the Type 1 trial.The Type 2 trial will make for a much better label but we don't need even that one for approval.If you look at trial # 24 that also started in 2008 but wasn't completed until May,2011.That's well after the last PDUFA date.It,like #27, had nothing to do with the submission.