"The 483 issues will go to the end of the year only because there is no need to get them done sooner. "
I wonder how many reinspections on average would it take to correct a 483? How are we sure that the minor issues and remedies would not fail in another inspection - what if 2 more reinspections would be necessary to straighten it out?
The only other purpose the delay serves would be to conserve cash. But if the issues were minor, it would not have been costly to fix it, right? Anyone has any idea how much can be saved in slow-mode?
I always thought there were ample time to do everything - as long as the management stamp their foots on it. But the reality was as follows:
Since the filing would not begin until 2006, let's wait till the last minute to get the jersey plant up and running - because Gold etal thought CMC would not be a problem. How many months elapsed since september 2005 before the pods were ordered?
Since FDA might approve provenge beause of the March AC panel positive recommendation, and it thought 9902b enrollment could be put on a back-burner, so by D-day, the trial was still 70 subjects short.
Since FDA has now issued CR and interim look would not happen until mid-2008 (partly because we did not see the need to hurry up the enrollment), well, we now have plenty of time to fix the CMC issue.
AI
