$CRMD Read this,its new: "Following a Type C meeting with the FDA, Sesen Bio Inc (NASDAQ: SESN) said it has reached an agreement with the FDA that the post-marketing confirmatory trial for Vicinium will enroll BCG-refractory patients who have received less-than-adequate BCG. Apart from the initial indication for BCG-unresponsive patients who have received adequate BCG, labeling will be expanded to include the additional population of patients who have received less-than-adequate BCG, provided the confirmatory trial is successful." I am expecting something similar with our Neutrolin, that it's labeling will be expanded behind the initial indication for hemodialysis and will include oncology and TPN if the post marketing confirmatory trial is successful. Watch it, it's coming.
  • 2