Amylin Pharma Byetta FDA letter concerns overblown, says Jefferies
Dec 24, 2009 7:50:00 AM
Jefferies said that the FDA's proposed Risk Evaluation and Mitigation Strategy, or REMS, requirement is not surprising or onerous. The analyst actually views the post-approval study requirement for thyroid cancer as a positive for Byetta and the GLP-1 class. He is encouraged because the risk-benefit of Byetta as a monotherapy was seen as favorable. Finally, the analyst notes that the company was only asked to do a post-approval epidemiological study to look at thyroid cancer rates, as the government refrained from implementing harsher alternatives. Shares are Buy rated with a $22 price target.
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