ANX’s RTF was probably the result of a technicality with stability testing, but we can’t yet be certain of that. It’s unusual for the FDA to change its rules regarding any aspect of NDA submissions without issuing guidance documents, so I’m a hesitant to accept ANX’s explanation as the gospel truth until there’s more information as to whether the FDA has in fact changed the rules on stability testing.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”