The FDA has issued an approvable letter for MGI Pharma's therapy for oral mucositis, but is requiring the drug developer to do a new Phase III trial before a full approval is made. The news of a new trial requirement sent its shares down as investors considered the likely impact on MGI. MGI CEO Lonnie Moulder said that the company will evaluate ways to "maximize the value of Saforis." He also noted that MGI hadn't been anticipating a significant financial contribution from the therapy next year.
- here's the AP report on MGI