Bradbury responds: "So, that's a great question. The tQT study wasn't required through the initial approval in the United States of Byetta. It was requested by another agency for us to complete and we did that for them. It is now, I believe, a requirement. This is part of the evolution of the increase in focus on cardiovascular safety for all medicines, particularly those in diabetes. It is now a requirement for all medicines in diabetes to have a tQT study, as far as I'm aware."
Bradbury alludes to the Canadian heart-safety study of Byetta, but he fails to mention that Amylin tried to keep the data out of FDA's hands during the Bydureon review. Had FDA been aware of the study at the beginning, it would have almost certainly been raised as an issue by U.S. regulators. Bradbury also ignores the fact that FDA very much wanted to see the Byetta tQT study in order to fully assess the safety of Bydureon.
"We responded appropriately to requests for additional data, and followed processes outlined by FDA for our submission," said Amylin's Izzo on Friday, disputing the FDA's charge that Amylin and its executives concealed important safety data related to Byetta and Bydureon from the agency.
In early November 2010, two weeks after the FDA rejected Bydureon, Amylin held its regular third-quarter conference call. According to a transcript, one analyst on the call prefaced his questions to Amylin executives with a note of thanks to how they handled the Bydureon setback. "Hey guys. Thanks for all the disclosure. I think I speak for everybody, you guys handled this well. We appreciate it."
"I appreciate your kind remarks with regards to disclosure," Bradbury says, in response. "We do try very hard to be as transparent as possible with everybody about what we know about the business."
The FDA has a problem with Bradbury's definition of "transparent" -- so, too, may investors and potential Amylin suitors now that the company's version of events leading to the second rejection of Bydureon have been revised.
--Written by Adam Feuerstein in Boston.
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