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Acer Therapeutics Inc. (ACER) ("Acer" or the "Company") is a pharmaceutical company headquartered in Newton, Massachusetts. The Company's focus is to acquire commercial or near-commercial stage orphan or ultra-orphan drugs to treat rare and ultra-rare diseases with critical unmet medical needs.
Last June, the Company suffered a major set back when the New Drug Application ("NDA") for its lead drug EDSIVO resulted in a Complete Response Letter ("CRL") being issued by the FDA.
On December 30, 2019, Acer submitted a Formal Dispute Resolution Request to the Office of New Drugs