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Wednesday, December 26, 2018

FDA accepts Acer Therapeutics’ NDA and priority review


Acer Therapeutics (NASDAQ:ACERannounces that the FDA has accepted for review Acer’s NDA for EDSIVO for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation.
The FDA also granted a priority review of the NDA and assigned a PDUFA target action date of June 25, 2019.
Priority Review shortens the review clock to six months from the standard 10 months.

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