The agency believes there was not a sufficient weight of clinical evidence from the limited number of patients included in the phase II data to conclude that the risk benefit for patients has been proven beyond doubt.
Ark said it will be examining the feedback regarding the outstanding concerns, when received, before deciding how to progress the regulatory approval process. The company believes the concerns may be able to be resolved through the provision of further data or analyses from the existing phase II trials. However new data may be required from the larger ongoing phase III study.
According to Ark, the phase II clinical trials completed to date have shown that Cerepro treatment produces an average extension of 7.5 months of life, giving around 15.5 months survival compared to the standard care group, which survived around 8 months.