FDA advisable that Ocugen “pursue a Biologics Licence Utility (BLA) submission as a substitute of an EUA software” and “requested extra data and knowledge”. Ocugen anticipates that knowledge from extra medical trials will probably be wanted to assist the submission. “We have been near finalising our EUA software once we obtained (FDA’s) suggestion to pursue a BLA path. Whereas this can lengthen our timelines, we’re dedicated to bringing Covaxin to the US,” stated Ocugen’s Shankar Musunuri. companies