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Fly News Breaks for September 10, 2019
ITCI
Sep 10, 2019 | 10:12 EDT
SVB Leerink analyst Marc Goodman reiterated an Outperform rating on Intra-Cellular after the FDA said it does not have plans to schedule an Advisory Committee, or AdCom, meeting in connection with its review of the company's New Drug Application for lumateperone for the treatment of schizophrenia. In a research note to investors, Goodman says that while he is "surprised" at the FDA's move, he notes that the FDA "has not been doing AdComs like they used to, and this product may fit into that new paradigm," and believes no AdCom is "probably good news." Goodman also notes that some investors have expressed concern with the efficacy data because of prior failed studies for Luma, but feels the FDA understands that this is a part of drug development in the category.