To: Robohogs who wrote (136 ) 12/14/2006 11:12:44 AM From: tuck Read Replies (3) | Respond to Givens said the FDA "would be within its rights" to restart the clock, but refused to speculate on whether or not they would do so. He said that he learned of the letter last night and had not had the chance to speak to the people who would be doing the reformatting. As such, he did not know if it would be a few days or a few hours, but strongly suggested that early next week at the latest, they'd be able to resubmit. He emphasized that they got communications from the FDA of this sort during the review process, but usually by email. I gather that since the FDA for some reason chose do put this formatting request into an official letter, ENCY is obligated to go public with it. My impression is that it is not anything of the magnitude of NBIX' early screwup of their electronic submission for Indiplon.
