The Food and Drug Administration sure gave Amylin Pharmaceuticals
The companies announced bad news yesterday. The FDA wouldn't let Amylin use its in vitro-in vivo correlation studies to prove that the extended-release Byetta manufactured on a commercial scale at its new plant using Alkermes' technology is the same as the drug manufactured on a smaller scale that was used in clinical trials.
The companies, along with marketing partner Eli Lilly
The other possibility, a new bridge trial, could result in the company not being able to file a new drug application by its goal of the middle of next year. A delay would be a huge benefit to Novo Nordisk
The companies and investors knew a delay was possible -- the FDA is giving Genzyme
Amylin may be knocked down, but this is only round one of a three round fight. Don't give up on "the kid" yet.