Nearly three years after being handed a rejection by the EMEA for Yondelis, an experimental therapy for soft tissue sarcoma, Spain's Zeltia says it plans to submit a new application in two to three months. The announcement closely follows a meeting with the EMEA on the STS-201 trial. Zeltia partner Johnson & Johnson says it will submit an application to the FDA once Phase III trials begin.
- here's the AFX report for more information