Lilly and Avid Receive Complete Response Letter from FDA for Amyvid™ (florbetapir F 18 injection)
The complete response was primarily focused on the need to establish a reader training program for market implementation that helps to ensure reader accuracy and consistency of interpretations of existing Amyvid scans.
"Lilly and Avid have been engaged in an active and ongoing dialogue with the
Since questions on the reader training program were raised by
About Amyvid™ (florbetapir F 18 injection)
Amyvid is a molecular imaging agent under investigation for PET imaging of beta-amyloid plaque in the brain. Clinical studies for Amyvid are being conducted in the E.U., North and South America,
About
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in
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This press release contains forward-looking statements about Amyvid™ (florbetapir F 18 injection) for use as a molecular imaging tool for the detection of β-amyloid (beta-amyloid) plaque in the brains of living patients. It reflects Lilly's current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that Amyvid will be approved by the
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