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FDA Grants Acceptance To File And Priority Review For TopoTarget A/S's Beleodaq™ (Belinostat) NDA In PTCL


2/6/2014 9:44:33 AM

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Topotarget A/S announces that the FDA has granted acceptance to file and Priority Review for the BeleodaqTM NDA for the treatment of relapsed or refractory PTCL. The FDA decision date based on PDUFA is set for August 9, 2014. The acceptance to file entails a milestone payment of USD 10 million and 1 million shares in Spectrum Pharmaceuticals, Inc. to Topotarget.

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