Posted by jrbecker on March 15, 2005, at 9:33:23
In reply to Re: Anxiety, Ocinaplon and clinical trials » pseudonym, posted by KaraS on March 15, 2005, at 3:39:02
it's extremely unfortunately, but analysts are predicting a big slowdown on approval timelines from the FDA. Given all the media attention currently surrounding the agency, there is enormous pressure to put more scrutiny on safety protocols.
I think DOV is doing the right thing by being proactive with further liver testing. This will most likely expedite the review process once submitted. So perhaps this will actually save some time in the end. But once again, I think we'll see the typical drug review timeframe of 12-16 months no longer be the norm -- at least until less criticism falls on the agency.
poster:jrbecker
thread:471132
URL: http://www.dr-bob.org/babble/20050312/msgs/471240.html