The sponsor of this EAP will limit the publication of any partial data collected by any participating treating physician or site without prior written authorization.
With rare exceptions, such authorization will likely come after the sponsor has closed program enrollment, completed the data analysis and evaluated the final data set for the primary safety outcomes.
The rationale for this approach is that the data being collected under the U.S. COVID Plasma EAP will be used to assess safety and help guide regulatory decision-making. Thus, per FDA guidance, the data should not be subdivided until the sponsor has completed key safety and — to the extent possible — efficacy analyses.
Data Safety Monitoring Board Report Summary