Goose . Is it possible the wait on the new trial protocol is a positive ? Maybe be FDA is correct considering the ole patient data . Is does match historic percentage deaths of past EIND’s . But do you have a link to the statement of when this was mentioned or printed ??
Did THE FDA EVER APPROVE?????
“”””What I remember when the FDA approved our extension was the mention of only 70 people would be needed in the critical group to give us a stronger p-value and maybe a better overall mortality with some adjustments to the protocol.”””””