The FDA declined to review Moderna's application for approval of an mRNA seasonal flu vaccine called mRNA-1010. The reason for this is the RTF letter, which criticizes the design of the third phase of the clinical trial, especially the control group with the licensed standard-dose seasonal influenza vaccine. The FDA stated that this control group does not reflect the best available standard of care. Moderna says no federal regulations or FDA guidelines require a best-standard-of-care control group, and that the FDA agreed to this design when planning the study with CBER. Moderna CEO Stéphane Bancel called the decision an obstacle to the development of innovative drugs in the US. The company published an RTF letter requesting a meeting with the FDA to determine next steps. The vaccine is currently under trial in the EU, Canada and Australia, and Moderna does not anticipate an impact on financial forecasts.[1]