BiondVax Pharmaceuticals announced the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) reviewed BiondVax's Phase 3 trial plan, provided advice, and allowed the company to proceed with the Phase 3 clinical trial plan for M-001, BiondVax's universal flu vaccine candidate. The CHMP advice will facilitate procedures in the countries where the Phase 3 study will take place.
The CHMP response states, "It is agreed that a single pivotal efficacy trial that provides a robust demonstration of efficacy against laboratory-proven influenza like illness (ILI) could suffice for an approval."