Msg 7551 of 7559 at 2/13/2013 2:17:52 PM by
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In response to msg 7550 by pineappleguava ignore topic, view thread, thread start
Re: Ru, in your opinion, when would they get approval given manufacturing issues?
Think 'rolling submission' in which clinical data is submitted for review and CMC data is provided as it becomes available. This approach an be used to trim time off of the timeline. The use of CMOs with solid FDA inspection track records etc will minimize the needs for pre-approval inspections as well. I would expect that a lot of info will be seen in the next Q update, as I would expect to see a large increase in the burn rate as outsourcing costs etc will be seen in the numbers. This is good and will indeed be an indication that the 'Manhattan project' is well under way.