Cerepro sitimagene ceradenovec regulatory update

Ark filed a formal request to EMEA for reexamination of an MAA for Cerepro sitimagene ceradenovec to treat operable malignant glioma. Last month, EMEA's CHMP issued a negative opinion on the MAA stating that data from the Phase III trial included in the application indicated that the benefits of Cerepro did not outweigh its risks (see BioCentury, Dec. 21, 2009). The company said it will provide additional data from a Phase III trial to support the reexamination, and expects a final decision early next quarter. ...