Amylin To Resubmit Symlin In June; Ex-Guidant Exec Graham Named CEO
Executive Summary
Amylin's resubmission plans for Symlin will give the diabetes agent a chance for approval before the end of 2003
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Symlin “Approvable” Letter Will Be Addressed By Ongoing Trials, Amylin Says
Amylin hopes that data from two ongoing open-label Symlin trials will address questions outlined by FDA in an "approvable" letter for the diabetes agent
Symlin “Approvable” Letter Will Be Addressed By Ongoing Trials, Amylin Says
Amylin hopes that data from two ongoing open-label Symlin trials will address questions outlined by FDA in an "approvable" letter for the diabetes agent
Amylin’s Symlin resubmitted
Amylin submits amended NDA for diabetes agent Symlin June 17, making FDA user fee goal date Dec. 17. Amendment includes dose titration study data requested in October 2001 "approvable letter." Amylin already is planning "concentrated" detailing strategy (1"The Pink Sheet" June 16, 2003, p. 34)...