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Seattle Genetics, Inc. Message Board

  • josve942 josve942 Sep 18, 2013 2:35 PM Flag

    9/14 DECISION

    SCR200, please answer the question re. fda extending ADCETRIS DURATION.

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    • We repeatedly tried to tell newbies on this board that the FDA ruling came months ago, that the Adcetris 16-cycle treatment limitation already has been removed, and that the Sept. 14 PDUFA was no longer relevant or even in force. Here is SGEN CEO Clay on this issue just last week: “Clearly, the thing that was most important to us was getting rid of the 16-cycle limitation….,” Siegall said. “We were very pleased to get the 16-cycle cap removed…. We got pretty much everything we were looking for.”

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