Epix upbeat on mixed appeal decision from FDA, eyes late 2008 approval
This article was originally published in Clinica
Executive Summary
The US FDA has turned down Epix Pharmaceuticals' appeal for immediate approval of its MRI blood pool imaging agent, Vasovist, but has said that further trials of the product may no longer be necessary. A blinded re-read of the company's completed phase III trial data will now be carried out under the guidance of the agency. It the results prove positive, they could support an approval submission to the agency. The move has prompted the company to estimate an end-of-2008 approval decision for the product "if all goes well".
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