Pfizer fell over ? You mean the timeline got stretched out a bit...

Pfizer fell over ? You mean the timeline got stretched out a bit in the US ?

It's all regulatory with FDA having a query that needs to be addressed around the potency assay matrix before they can start enrolling patients in the Phase 3.





To date, we have opened 15 trial sites in 8 countries (Italy, Spain, Israel, the UK, South Korea, Japan, Russia and Canada). In the U.S., we are actively working with the FDA to address outstanding questions related to our Investigational New Drug Application, including technical aspects of our potency assay matrix, so that we can begin enrolling patients in Phase 3 U.S. study sites. While we have high confidence in our current quality control overall and with the potency assay matrix, which has been accepted in countries outside of the U.S., the FDA has additional technical requests that we are working to address as quickly as possible. We understand the sense of urgency among many families in the U.S. who were hoping for sites to open soon. While we cannot speculate at this time as to when sites may open in the U.S., we do not expect a resolution in the first half of 2021. We are working with a sense of urgency and hope to reach alignment with 8 the FDA as soon as possible"