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Biotech / Medical : CLTR COULTER PHARMACEUTICAL
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To: Bob L who wrote (160)12/8/1998 10:30:00 PM
From: Vector1  Read Replies (1) of 666
 
Bob,
Fast track allows company's to submit portions of their NDA as they become ready. YOu have to negotiate which portions are submitted when but in effect the FDA is reviewing as the company is finalizing all of its submission info. An NDA is a very complex voluminus series of documents and can be quite time consuming to put together even months after the clinicals are finished. My guess is they will first be submitting trial efficacy and safety data which will be followed up by manufaturing info and inspections. The FDA reviews each step of the manufacturing process all of which has to be properly documented. It is a monumental task for a company that has never done it before.
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