Published in Obesity and Diabetes Week, October 18th, 2004
Resubmission of a complete response after receipt of an approvable letter is intended to answer all of the questions that need to be addressed prior to approval.
The FDA is expected to respond to this new submission within 6 months.
"Based on numerous discussions with the FDA, we believe that data generated since our last Symlin submission in June 2003 and additional analyses of earlier studies, including the pivotal studies, answer the...
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