Summary of the EMA September 2022 Qualification Opinion for PROCOVA™

On September 15, 2022, the European Medicine Agency (EMA) qualified Unlearn's patent-pending procedure to leverage historical  data and machine learning to reduce sample sizes or increase power in pivotal trials using patient-specific prognostic scores without creating bias. The adopted qualification opinion focuses on our 3-step PROCOVA™ procedure, which provides the regulatory framework for  planning and conducting a Phase 2 or Phase 3 TwinRCT™, the novel randomized  trial enhanced with Prognostic Digital Twins.

The adopted qualification opinion was published including  links to a handbook for the target trial statistician and two other documents that were  part of the review process with Committee for Medicinal Products for Human  Use (CHMP). The four documents collectively are 62 pages long. Thus, the purpose of this document is to (1) direct the reader to the most important  sections of the qualification opinion, (2) to give a brief overview of the  critical elements of the PROCOVA™ procedure, and (3) to address FAQs about the opinion and the supporting documents.

The  draft qualification opinion, published in March of 2022, can be found here.