Due to the rapid enrollment of patients in the ... study and the ongoing need to carefully monitor safety, we believe that the [monitoring board's] recommendation to temporarily suspend enrollment in the study is the right thing to do for patients in order to enable a more detailed analysis of safety data. |
This application represents a summary of data from more than six years of rigorous clinical study and the dedication of thousands of patients and physicians hoping to improve outcomes for those with this devastating disease. We look forward to working with the FDA in our efforts to bring this potential therapy to patients quickly as it may offer benefit to patients with all types of wet AMD. |
We believe that the [safety monitors'] recommendation to temporarily suspend enrollment in the study is the right thing to do for patients in order to enable a more detailed analysis of safety data. |