The ODAC recommended by a vote of eight to five that the FDA delay the approval ofselinexor until the results of the randomized Phase 3 BOSTON study in multiple myeloma are available. We are working with the FDA as it continuesto review our NDA requesting accelerated approval of selinexor. In March 2019, the FDA extended the PDUFA action date from April 6, 2019 untilJuly 6, 2019
|
Thread abonnieren
