ANX- "Of course, a 30% injection site reaction by users of Vinorelbine might well fit that definition..wouldn't you think"
Even if you eliminate all reactions there's better drugs available. How can you get an unmet need designation for a second line drug. Its not the reaction thats the problem its the drugs efficacy.
zigzagman: I can’t think of a case where an NDA submitted under Section 505b2 was granted a priority review, so I think such an outcome is unlikely for ANX-530. Regards, Dew