Posted On: 10/16/2014 6:07:38 PM
Post# of 30070
A question to others that know more about the orphan application process than I do. I do know they have to deliver a response in 30 days. One of the valid responses is to request more information. I suspect they do that to give themselves more time.
JN said that he expects the FDA to respond in early 2015. So should I read between the lines that there will be at least one "Request for more information"?
JN said that he expects the FDA to respond in early 2015. So should I read between the lines that there will be at least one "Request for more information"?
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