Accelerated Approval Procedure: How to Demonstrate the High Therapeutic Benefits?

A summary of 15 to max. 30 pages is expected for the application for an accelerated approval procedure. criterion c, supported by a description of the studies performed is often responsible for the rejection of an application.. Information on the design of the clinical trials, primary outcomes, and a summary of the results on efficacy and safety should be provided. Complete clinical reports are not to be submitted. The applicant should also evaluate the data on efficacy and safety (as in a Clinical Overview) and, based on this data, give reasons why a high therapeutic benefit can be expected.