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POZEN Inc. Message Board

  • yrubinek yrubinek Apr 27, 2014 1:33 AM Flag

    FDA actually approve both POZN's PL doses. This CRL gives FDA time to finalize labeling.

    "There were no clinical or safety deficiencies noted with respect to either PA8140 or PA32540 and no other deficiencies were noted in the CRL"

    "Final agreement on the draft product labeling is also pending"

    Conclusions :
    (1) FDA is short with human resources.
    (2) FDA buying some time to finalize labeling.
    (3) 90 days approval delay.

    Sentiment: Strong Buy

7.07+0.02(+0.28%)Nov 25 4:00 PMEST