WILEX AG (ISIN DE0006614720 / WL6 / Frankfurt Stock Exchange) and IBA (Ion Beam Applications SA: Reuters IBAB.BR and Bloomberg IBAB.BB) today announced that the Pre-BLA Meeting with the American Food and Drug Administration planned for the second quarter has taken place. The aim of this type of meeting is to discuss the application for approval and the approval process for a product in advance of filing. Two issues remain to be resolved by WILEX and its partner IBA.

The FDA had granted WILEX a special protocol assessment (SPA) for the design of the pivotal Phase III trial with REDECTANE® prior to the start of the trial. With this SPA the FDA confirms that the design and planned analysis of the clinical trial adequately address the requirements for a regulatory submission for REDECTANE®. The aim of the Phase III REDECT trial was to determine whether the combination of REDECTANE® with positron emission tomography (PET) and computer tomography (CT) versus the use of CT alone could improve the diagnosis of renal masses. Sensitivity and specificity were the defined endpoints of the study.

The endpoint sensitivity, the correct diagnosis that clear cell renal cell cancer is present, was reached with statistical significance (p value, p≤0.016) compared to CT. The study endpoint specificity, the correct diagnosis that clear cell renal cell cancer is not present, was confirmed with a highly statistical significance (p

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