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Noting 25 September as the target action date under the Prescription Drug User Fee Act (PDUFA), Pain Therapeutics was informed in July 2016 that FDA had determined that an advisory committee meeting was unnecessary for the opioid, and that the hearing would not be held as previously planned on 5 August.

“Pain Therapeutics also stated that the FDA advised them that the regulatory review remains active and is on-going, and the PDUFA date of September 25, 2016 remains unchanged,” the SEC filing says.

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