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Re: DewDiligence post# 225659

Wednesday, 07/24/2019 11:10:52 AM

Wednesday, July 24, 2019 11:10:52 AM

Post# of 251620
ITCI -7%—(vs -32%/AH)—on PR explaining reason for adcomm cancellation:

https://www.globenewswire.com/news-release/2019/07/23/1886816/0/en/Intra-Cellular-Therapies-Provides-Update-on-FDA-Advisory-Committee-Meeting-for-Lumateperone-for-the-Treatment-of-Schizophrenia.html

The Company recently provided additional information to the FDA in response to information requests relating to non-clinical studies. The FDA cancelled the Advisory Committee meeting to allow sufficient time to review this new and any forthcoming information as they continue the NDA review. This information may result in an extension of the September 27, 2019 Prescription Drug User Fee Act (PDUFA) target action date for the lumateperone NDA.


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