The FDA is going to be hard pressed to find a good reason to extend the 3/5/10 Pdufa Date.

Efficacy - Well Established

Safety - Well established thanks to the recent label update which covers any and all of the most recent safety issues surrounding both clinical and post marketing events for the Exenatide Compound.

Manufacturing - Amylin was made to jump through several hoop's prior to submitting an NDA in order to prove bioequivalency and the drug being produced at Amylin's Ohio Facility is being used in clinical trials and is ready to be produced at commercial scale.

Unless the FDA comes up with a bogus issue to delay their decision, the NDA should be signed, sealed and delivered on 3/5/10.

JMO
Kevinmik