Drug is approved in Canada and EuropeBut the FDA decides to stick it to them for nothing. FDA believes it is smarter (give me a break they just allowed mRNA to be used as a vaccine without any approvals). than others. Here is what it is all about.
"the FDA has determined that it cannot approve the NDA in its present form and has provided recommendations specific to additional clinical/statistical data and analyses pertaining to the primary and secondary endpoints of the completed pivotal Phase III study"
Absolute verbal garbage. Political games being played as big pharma putting pressure on the small guy.