FDA delay of Impax's Rytary should have little impact on outlook, says Needham After the FDA extended the PDUFA for Impax's Rytary by three months but didn't request any new clinical trials, Needham expects the move to little impact on the outlook of investors, who had expected the drug to be approved with little difficulty. The firm expects the drug to be approved but believes that peak sales will be below the company's guidance. Needham maintains a Hold rating on the shares.
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