Lymphoseek tilmanocept regulatory update

Navidea said it believes EMA's CHMP found the safety and efficacy data submitted in a MAA for Lymphoseek tilmanocept for use in intraoperative lymphatic imaging for breast cancer and melanoma was "acceptable" based on feedback the biotech received at a meeting with CHMP. The company said the committee is now focusing its review on the remaining areas of product specifications and on data from the Phase III trial in head and neck cancer. The MAA covers the use of Lymphoseek for general lymphatic mapping and is not restricted to any particular solid tumor type. The company still expects "material" revenue generation in Europe beginning in 2015. ...